Oracle® Argus Safety

User's Guide

Release 8.2.2

F33921-01

July 2020

Oracle Argus Safety User's Guide, Release 8.2.2

F33921-01

Copyright © 2020, Oracle and/or its affiliates.

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Contents

Preface

- Where to Find More Information

- Documentation Accessibility

- Conventions

1 Know your basics

- 1.1 Log in

- 1.2 Change your password

- 1.3 Begin on the Personal Argus Status page

- 1.4 Use the Quick Launch Toolbar

- 1.5 Use field validations

- 1.6 Acceptable date formats

- 1.7 Use other (than English) language text

- 1.8 Enter reasons for missing (Null Flavor) data

- 1.9 Log out

- 1.10 Dynamic workflow indicator

- 1.11 Integrate with Argus Insight

- 1.11.1 Sharing a case series in Argus Safety with Argus Insight

- 1.11.2 Sharing a case series in Argus Insight with Argus Safety

- 1.12 Case form user preferences

- 1.13 FAQs

- 1.13.1 Why can't I access Argus Safety?

- 1.13.2 What happens if I enter a wrong password?

- 1.13.3 Why can't I change my password?

- 1.13.4 How do I get help?

2 Enter case data

- 2.1 Create a new case

- 2.1.1 Enter a new case

- 2.1.2 Initial case entry—fields descriptions

- 2.1.3 Check for duplicates

- 2.1.3.1 Receipt range—fields descriptions

- 2.1.4 Initial case entry—BookIn dialog box

- 2.1.5 Accept incoming cases

- 2.1.5.1 View pending case

- 2.1.5.2 View rejected cases

- 2.2 Enter general information

- 2.2.1 General information—field descriptions

- 2.2.2 Enter study information

- 2.2.2.1 Study information—field descriptions

- 2.2.3 Enter reporter information

- 2.2.3.1 Add reporter information

- 2.2.3.2 Reporter information—field descriptions

- 2.2.4 Enter literature information

- 2.3 Enter patient information

- 2.3.1 Enter current medical status

- 2.3.2 Copy patient information from reporter information

- 2.3.3 Patient information—field descriptions

- 2.3.4 Enter patient notes

- 2.3.5 Enter patient details

- 2.3.5.1 Enter pregnancy information

- 2.3.6 Enter patient death details

- 2.3.6.1 Event death details—field descriptions

- 2.3.7 Enter other relevant history

- 2.3.7.1 Other relevant history—field descriptions

- 2.3.8 Enter lab data—lab test and test results

- 2.3.8.1 Lab data—field descriptions

- 2.3.9 Enter additional test information

- 2.3.10 Enter parent information

- 2.4 Enter product information

- 2.4.1 Search for products

- 2.4.1.1 Product Browser based search

- 2.4.1.2 WHO Drug Browser based search

- 2.4.2 Enter time measurement information

- 2.4.3 Enter drug information

- 2.4.3.1 Product information—field descriptions

- 2.4.3.2 Enter product indications

- 2.4.3.3 Enter Quality Control information

- 2.4.3.4 Enter dosage regimens

- 2.4.3.5 Enter product details

- 2.4.3.6 Enter study drug information

- 2.4.4 Enter device information

- 2.4.4.1 Enter product information

- 2.4.4.2 Enter Quality Control information

- 2.4.4.3 Enter product indications

- 2.4.4.4 Select product delivered by device

- 2.4.4.5 Enter device component information

- 2.4.4.6 Device information—field descriptions

- 2.4.5 Enter vaccine information

- 2.4.5.1 Enter product details

- 2.4.5.2 Enter prior adverse events information

- 2.4.5.3 Enter product information

- 2.4.5.4 Complete vaccine administration form

- 2.4.5.5 Enter vaccine history

- 2.5 Enter event information

- 2.5.1 Events tab—field descriptions

- 2.5.2 Enter event information

- 2.5.2.1 Event information—field descriptions

- 2.5.2.2 Review a diagnosis-event relationship

- 2.5.2.3 Associate a symptom with the diagnosis

- 2.5.2.4 Auto-populate event information

- 2.5.2.5 Configure regulatory reporting rules

- 2.5.3 Enter event coding information

- 2.5.4 Enter seriousness criteria

- 2.5.4.1 Enter death details

- 2.5.4.2 Enter hospitalization details

- 2.5.4.3 Select nature of event

- 2.5.4.4 Enter event notes

- 2.5.5 Enter event assessment information

- 2.5.5.1 Event assessment tab—user actions

- 2.5.5.2 Filter event assessment details

- 2.5.5.3 Enter product-event details

- 2.6 Add attachments to your case

- 2.6.1 Enter additional information for the attachments

- 2.6.2 Sort attachments

- 2.6.3 Search for Documentum links

- 2.6.4 Attach files to a case

- 2.6.5 Enter keywords

- 2.6.6 Attach references to a case

- 2.6.7 View and print attachments

- 2.7 Review local labeling

- 2.8 Enable local data entry for Japan

- 2.8.1 Enable local data entry

- 2.8.1.1 About local fields

- 2.8.2 Access local case data lock functionality

- 2.8.3 Process an outlier

- 2.8.4 Activate local locking in Argus Safety

- 2.8.4.1 Enter local reports configuration seed data

- 2.8.4.2 Enter local users seed data

- 2.8.4.3 Enter local fields seed data

3 Process case data

- 3.1 Access cases

- 3.1.1 Search for a case

- 3.1.2 Search for a case assigned to you

- 3.2 Process cases

- 3.2.1 View assigned and unassigned cases

- 3.2.2 View the case workload for one or more individuals or sites

- 3.2.3 View the workflow status for cases

- 3.2.4 Route a case to another workflow state

- 3.2.5 Add a follow-up event to a case

- 3.2.6 Unblind cases to a study

- 3.2.7 Copy a case

- 3.2.8 Lock or unlock a case

- 3.2.9 Delete a case

- 3.2.10 Undelete a case

- 3.2.11 Formally close a case

- 3.2.12 Print case details for a case

- 3.2.13 Print letters and attachments for a case

- 3.3 Review cases

- 3.3.1 View correspondence contacts for a case

- 3.3.2 Generate a letter on a case

- 3.3.3 Track correspondence for a case

- 3.3.4 View case action items

- 3.3.5 View revisions for a case

- 3.3.6 View the audit log for a case

- 3.3.7 View the coding status of a case

- 3.3.8 Perform a medical review of a case

- 3.3.9 Perform a coding review of a case

- 3.3.10 Perform a regulatory submission review of a case

- 3.4 FAQs

- 3.4.1 What is a case owner?

- 3.4.2 Can I reassign a case to another owner?

- 3.4.3 When does a case become open?

- 3.4.4 How do I create a query-type action item for a case?

- 3.4.5 What happens to a query-type action item after its due date has passed?

- 3.4.6 How can I view a summary of all the open cases?

- 3.4.7 How can I view a summary of cases with open action items?

- 3.4.8 When can I formally close a case?

- 3.4.9 What happens to a study if I unblind the cases that are associated with it?

- 3.4.10 How can I track which case revision contains significant follow-up information for the case?

- 3.4.11 How can I interpret the differences between two narratives for a case?

- 3.4.12 What other case details can I retrieve from the Routing Comments log?

- 3.4.13 Can I view the original case from a copied case?

- 3.4.14 What are the lock states for a case?

- 3.4.15 Can I apply a local lock on a case that already has a local lock for another country?

- 3.4.16 If I am an Argus Safety Japan user, can I enter local data, copy or modify a case that has a global lock?

- 3.4.17 If I am an Argus Safety Japan user, can I apply both a local and a global lock on a Local PRPT case that I entered?

- 3.4.18 Can I change the outcome of a case as part of my medical review for the case?

- 3.4.19 Can I change the causality for a case during my medical review?

- 3.4.20 What do the case assessment values stand for?

- 3.4.21 Who is the MDR contact person?

- 3.4.22 How does Argus set the Receipt Date for a case?

- 3.4.23 How does Argus set the Aware Date for a case?

- 3.4.24 How does Argus set the Date Received value for a case?

- 3.4.25 Which actions can I perform on a saved letter?

- 3.4.26 Can I edit or remove a letter after it was sent for a case?

- 3.4.27 If I change the Date Sent value for a letter, must I also change the Due Date for the action item associated with the letter?

- 3.4.28 Where can I view action items for letters?

- 3.4.29 Why do only some action items for a case appear as Sent in Letter?

- 3.4.30 Can I auto-generate a letter for a case?

- 3.4.31 Which actions can I do on an auto-generated letter?

- 3.4.32 What does the coding status icon indicate for a case?

- 3.4.33 Why does a border appear for a coding action item for a case?

- 3.4.34 Why is there a green dot in the Notes area of a case summary?

- 3.4.35 Why do only some user names appear in bold in the Case Workload?

- 3.4.36 Why does the ( ) icon appear as the lock state icon for a case?

- 3.4.37 Why do some letter icons from the Contact Log have an exclamation mark?

- 3.4.38 Why does an asterisk (*) symbol appear next to the username for some users in the Case Routing dialog?

- 3.5 What if

- 3.5.1 The Medical Review page appears empty for a Case Form

- 3.5.2 The narrative text for a case contains blank spaces or placeholders

- 3.5.3 I can't change the assessed seriousness of a case

- 3.5.4 I can't change the determined listedness of a case

- 3.5.5 I can't select the language I need for my text narrative?

4 Filter cases with advanced conditions

- 4.1 Create a single filter

- 4.2 Create a set of related filters

- 4.3 Share filters with other users

- 4.4 Modify a filter

- 4.5 Use filters to view the case series list

- 4.6 Export the case series list to a spreadsheet

- 4.7 Import a case series list from the spreadsheet and save

- 4.8 Find filters

- 4.9 Access filters from the Advanced Condition Library

- 4.10 FAQs

- 4.10.1 What is an advanced condition?

- 4.10.2 What is an advanced condition query set?

- 4.10.3 How do the logical operators work?

- 4.10.4 How do the set operators work?

- 4.10.5 What is a case series (formerly Hit list)?

- 4.11 What if

- 4.11.1 I am unable to find a filter

- 4.11.2 I am unable to view cases that match the filter criteria

- 4.11.3 I am unable to view values of a codelist

- 4.11.4 While adding a value to a property, the Select button is disabled

5 Code an adverse event term

- 5.1 Autocode a term

- 5.2 Manually code a term

- 5.3 FAQs

- 5.3.1 Which dictionaries does Argus Safety support?

- 5.3.2 What is the MedDRA browser?

- 5.3.3 What are the five levels of the MedDRA dictionary?

- 5.3.4 What is a synonym?

- 5.3.5 What is autocoding?

- 5.3.6 What happens if you don't enable autocoding?

- 5.3.7 What are Standard MedDRA Queries (SMQs)?

- 5.3.8 What is a full search?

- 5.3.9 What is a non-current term?

- 5.3.10 How can I view details for a coded term?

- 5.3.11 How can I narrow my search in the MedDRA browser?

- 5.3.12 Why does a dictionary coding appear highlighted in yellow in the MedDRA browser?

- 5.3.13 Why can't I use the Export button to export a coding?

- 5.3.14 What is Null Flavor data?

- 5.4 What if

- 5.4.1 Autocoding is not enabled in my application

- 5.4.2 Autocoding is unsuccessful

- 5.4.3 I receive a "No Records Found" message when I manually code a term

- 5.4.4 The coding I previously used for a term now features an asterisk and can no longer be selected in the MedDRA browser, as it is labeled as non-current

6 Manage your Expedited Report submissions

- 6.1 Schedule an Expedited Report

- 6.1.1 Schedule a report manually

- 6.1.2 Auto-schedule a report

- 6.1.3 Create unscheduled expedited reports

- 6.1.4 Batch print or create reports

- 6.1.5 Review a draft Expedited Report

- 6.1.6 Review your scheduled reports

- 6.1.6.1 Review a list of your scheduled reports

- 6.1.6.2 View your scheduled reports

- 6.1.6.2.1 Report filter options

- 6.1.6.2.2 View filter results

- 6.1.7 View Expedited Report status

- 6.2 Submit your Expedited Reports

- 6.2.1 Generate an Expedited Report

- 6.2.2 Approve your report

- 6.2.3 Transmit an ICSR

- 6.2.4 Transmit several ICSRs at once

- 6.2.4.1 Filter reports

- 6.2.4.2 User options

- 6.2.4.3 View routing details

- 6.2.5 Print your reports

- 6.2.5.1 Bulk print user options

- 6.2.6 Store Expedited Reports in Documentum

- 6.3 Track your Expedited Report submissions

- 6.3.1 Track ICSR outgoing status

- 6.3.2 View ICSR transmit status

- 6.3.2.1 Search for reports

- 6.3.2.2 Search for ESM messages

- 6.3.2.3 View search results

- 6.4 Manage your Incoming ICSRs

- 6.4.1 Track incoming ICSR reports

- 6.4.1.1 Button and right-click options

- 6.4.2 Manage pending reports

- 6.4.3 Track bulk incoming ICSR reports

- 6.4.4 Search for duplicate reports

- 6.4.4.1 View duplicate search options

- 6.4.4.2 Search duplicates for incoming review

- 6.4.4.3 View differences report

- 6.4.4.3.1 Accept initial E2B cases as follow-up

- 6.4.5 View processed ICSR reports

- 6.4.5.1 Search for reports

- 6.4.5.2 View search results

- 6.4.6 Track ICSR incoming status

- 6.4.7 View message options

- 6.4.8 Find overdue reports

- 6.5 FAQs

- 6.5.1 What is a scheduled report?

- 6.5.2 What is a generated report?

- 6.5.3 What happens when a report is approved?

- 6.5.4 What is the difference between submitting and transmitting a report?

- 6.5.5 What happens when manually scheduling a Local Japan report?

- 6.5.6 What happens when auto-scheduling a Local Japan report?

- 6.5.7 What components are affected by the expedited reporting rules algorithm?

- 6.5.7.1 Suppression of duplicate reports

- 6.5.7.2 Blinded/forced distribution

- 6.5.8 When are follow-up reports created?

- 6.5.9 When are the amendments created?

- 6.5.10 Why can't I view a draft report?

- 6.5.11 Why doesn't my draft report print a follow-up number?

- 6.5.12 How does the Lock State Column under Reports > Compliance > Expedited allow me to sort my cases?

- 6.5.13 How do I view the status of my Expedited Report?

- 6.5.14 How do I know if an unscheduled report is due soon or needs to be submitted?

- 6.5.15 Where can I view single reports which have been generated as part of a periodic report?

7 Manage your periodic report submissions

- 7.1 Prepare content for periodic reports

- 7.1.1 Prepare your aggregate reports

- 7.1.1.1 Understand aggregate reports

- 7.1.1.2 View saved aggregate reports

- 7.1.1.3 Create a Case Data Analysis report

- 7.1.1.4 Create a CIOMS II Line Listing report

- 7.1.1.5 Create a case listing report

- 7.1.1.6 Check aggregate report execution status

- 7.1.2 Periodic report types

- 7.1.2.1 Store periodic reports in Documentum

- 7.1.2.2 View a summary of periodic regulatory reports

- 7.1.2.3 Use the library page

- 7.1.3 Prepare content for a Clinical Trial Periodic Report

- 7.1.3.1 Create a Clinical Trial Periodic Report

- 7.1.3.2 Enter common fields information

- 7.1.3.3 Configure subject in the report header

- 7.1.3.4 Select products to include in CTPR

- 7.1.3.5 Configure license or study in the report header

- 7.1.3.6 Select inclusion criteria

- 7.1.3.7 Use the Data Lock Point (DLP) version

- 7.1.3.8 Use DLP queries for dates

- 7.1.3.9 Use As of Reporting function

- 7.1.3.10 Find DLP and As of Query functionality

- 7.1.3.11 Include line listing

- 7.1.3.12 Add data elements

- 7.1.3.13 View selected data elements

- 7.1.3.14 Group cases

- 7.1.3.15 Specify summary tabulations for line listing

- 7.1.3.16 Generate single case submission report

- 7.1.3.17 Select summary listing

- 7.1.3.18 Schedule the report

- 7.1.3.19 Setup frequency of the scheduled reports

- 7.1.3.20 Configure security level of the report

- 7.1.3.20.1 Use report templates

- 7.1.4 Prepare content for an ICH PSUR

- 7.1.4.1 Create Periodic Safety Update Reports (PSURs)

- 7.1.4.2 Enter common fields information

- 7.1.4.3 Configure subject in the report header

- 7.1.4.4 Select products to include in ICH PSUR

- 7.1.4.5 Select inclusion criteria

- 7.1.4.6 Include line listing

- 7.1.4.7 Add data elements

- 7.1.4.8 View selected data elements

- 7.1.4.9 Group cases

- 7.1.4.10 Specify summary tabulations for line listing

- 7.1.4.11 Include CIOMS reports

- 7.1.4.11.1 Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials

- 7.1.4.11.2 Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources

- 7.1.4.12 Add cumulative summary

- 7.1.4.13 Add FDA PSUR support information

- 7.1.4.14 Generate single case submission report

- 7.1.4.15 Select summary listing

- 7.1.4.16 Schedule the report

- 7.1.4.17 Setup frequency of the scheduled reports

- 7.1.4.18 Configure security level of the report

- 7.1.4.18.1 Use report templates

- 7.1.5 Prepare content for a US IND periodic report

- 7.1.5.1 Create new IND report

- 7.1.5.2 Enter common fields information

- 7.1.5.3 Configure subject in the report header

- 7.1.5.4 Select products to generate the report

- 7.1.5.5 Select inclusion criteria

- 7.1.5.6 Include line listing

- 7.1.5.7 Specify summary tabulations for line listing

- 7.1.5.8 Schedule the report

- 7.1.5.9 Configure security level of the report

- 7.1.6 Prepare content for an NDA periodic report

- 7.1.6.1 Create NDA summary report

- 7.1.6.2 Enter common fields information

- 7.1.6.3 Configure subject in the report header

- 7.1.6.4 Select products to generate the report

- 7.1.6.5 Select inclusion criteria

- 7.1.6.6 Include line listing

- 7.1.6.7 Specify summary tabulations for line listing

- 7.1.6.8 Schedule the report

- 7.1.6.9 Configure security level of the report

- 7.2 View scheduled periodic report information

- 7.2.1 Available user options

- 7.2.2 View report details

- 7.2.3 View report schedule details

- 7.2.4 View report routing history

- 7.3 Submit a periodic report

- 7.3.1 Specify submission details

- 7.3.2 Add comments

- 7.3.3 Transmit a report

- 7.3.4 View report generation status

- 7.3.5 Create unscheduled periodic reports

- 7.3.6 Approve and submit a report

- 7.3.7 View submitted reports

- 7.3.8 Use bulk report

- 7.3.8.1 Filter bulk reports

- 7.3.8.2 View bulk report filter results

- 7.3.8.3 Print reports in bulk

- 7.3.8.4 Sort cases

- 7.3.8.5 Lock state icon options

- 7.4 Track your periodic report submission

- 7.4.1 Use submitted reports search results

- 7.4.2 Reopen submitted reports

- 7.4.3 About initial and follow-up cases in periodic reports

- 7.4.4 View batch reports scheduled for generation

8 Work in a multi-tenant Argus environment

- 8.1 Access your global worklist items

- 8.2 FAQs

- 8.2.1 What is a tenant?

- 8.2.2 What is multi-tenancy?

- 8.2.3 Can I open both the Global Portal homepage and the Argus Safety application in my browser?

- 8.2.4 Can I open the Argus Safety application a second time for the same or a different tenant?

- 8.2.5 Can I open the Argus Safety application for different tenants?

- 8.2.6 Can I launch different Argus applications in separate browser windows?

- 8.2.7 Is there a Japanese version of the Global Portal homepage?

- 8.2.8 Which actions can I perform from my global worklist?

- 8.2.9 Can I perform actions on multiple cases from my global worklist?

- 8.2.10 Can I open Argus Safety cases for multiple tenants from my global worklist?

- 8.3 What If

- 8.3.1 There are no items in my global worklist

- 8.3.2 I can't see cases for a tenant even though I used its Enterprise ID as search criteria for my global worklist

- 8.3.3 The results list from my global worklist includes case data items that are not referred to by worklist menu actions

- 8.3.4 A case data item appears in my Argus Safety worklist, but does not appear in the results list from my global worklist

Preface

This document describes the components of the Argus Safety Solution application.

Where to Find More Information

Oracle Help Center

The latest user documentation for Oracle Health Sciences products is available at http://docs.oracle.com/en/industries/health-sciences/.

My Oracle Support

The latest release notes, patches and white papers are on My Oracle Support (MOS) at https://support.oracle.com. For help with using MOS, see https://docs.oracle.com/cd/E74665_01/MOSHP/toc.htm.

Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers that have purchased support have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Conventions

The following text conventions are used in this document:

Convention

Meaning

boldface

Boldface type indicates graphical user interface elements associated with an action, or terms defined in text or the glossary.

italic

Italic type indicates book titles, emphasis, or placeholder variables for which you supply particular values.

monospace

Monospace type indicates commands within a paragraph, URLs, code in examples, text that appears on the screen, or text that you enter.

1 Know your basics

1.1 Log in

1. Open Microsoft Internet Explorer and enter the URL for Argus Safety in the address bar.

Note:
Contact your System Administrator for the Argus Safety URL.

2. When the Argus login screen opens, perform the following:

1. Enter username and password.

2. Select a value from the Database drop-down list.

3. Click Login.

The default Home page set by the Administrator appears. This can be the Personal Argus Status page or one of the worklists, depending on user preferences defined in the Argus Console.

1.2 Change your password

1. Hover over the Utilities menu, and click Change Password.

2. Enter your current password in the Old Password field.

3. Enter the new password in the New Password field, and confirm the new password by re-entering it.

4. Click OK.

Note:
This capability is available when the user ID and password are maintained in Argus Safety and does not apply if your Oracle single sign-on is enabled.

1.3 Begin on the Personal Argus Status page

The Personal Argus Status page displays the cases assigned to you, your Contact Log entries, your pending action items, and any overdue action items.

- To view your assigned cases, check the Cases Assigned checkbox.

- To view your Contact Log entries, check the Contact Log Entries checkbox.

- To view your pending action items, check the Action Item Entries checkbox.

- To view your overdue actions items, check the Overdue Action Items checkbox.

Note:
If the Personal Argus Status page is not your Home page, hover over the Dashboards menu and click Personal Argus Status.

1.4 Use the Quick Launch Toolbar

The Quick Launch Toolbar is on the top right side of the screen.

Place the cursor over each icon to view the tool tip, which describes the role of each icon.

Note:
Shortcut keys are driven by a combination of common profile switches and menu access rights. For example, the Case Save shortcut/icon is visible only to users who have been granted access to save the case in the group configuration. If the menu option is disabled in the group configuration for a user, the respective shortcut /icon is also removed.
Certain shortcuts/icons such as Field Validation are enabled only through a common profile switch. Shortcuts/icons that are driven through common profile switches are global to all users and are not controlled by group permissions.

Icon

Tool Tip

Description

New Case from Image

Displays a new case from an image.

New Case

Displays the Initial Case Entry dialog box.

Open Case

Displays the Case Search dialog box.

Close Case

Closes the case.

Print Case

Displays the Case Print dialog box.

Save Case

Saves the case with any changes made.

Forward Case

Displays the Case Routing dialog box and enables you to forward the case.

Return Case

Displays the Case Routing dialog box and enables you to return the case.

Worklist

Displays the Worklist dialog box.
If no default Worklist option is defined, then Worklist - New is displayed.

Lock Case

Displays the Case Lock or Case Unlock dialog box. This icon is enabled only for a Local PRPT Case and only if the case has been globally locked.

Local Lock

Displays the Local Lock or Local Unlock dialog box to allow a user to locally lock or unlock a case.
This icon is a toggle icon that allows users to do a Local lock or Local unlock depending on the global and local lock state of the case.

Note: This icon is visible only for a Local Potential Reportable case (Local PRPT case) and only if the case has been globally locked.

Medical Review

Displays the Medical Review dialog box.

Coding Review

Displays the Coding Review dialog box.

Draft Report

Opens the View Draft pop-up. Select the following and click OK.
Report Form—Displays the list of expedited reports.

Destination—Displays the list of reporting destinations as configured in Console.

Product—Displays the list of products added in the case.

ICSR Check

Performs the function that prints the ICSR report - DTD Length Check Warnings and ICSR report - DTD Validation.

Validation Check

Performs case validation.

1.5 Use field validations

1. Click the icon next to a field to view its corresponding Field Justification dialog box.

2. This dialog box asks the user for a justification to perform the selected action. To overwrite the warning:

- Enter a specific reason.
OR

- Select a standard reason from the message box.

3. Click OK to overwrite the field justification warning.
The orange icon changes to green.

The fields in the application are either required or optional. Each field type displays with a different colored icon:

- A red icon signifies that a mandatory validation check has not been met.You need to correct the data entry before being able to save a case.

- An orange icon signifies that an optional validation check has not been met. You need to enter justification but can then continue to save the case.

1.6 Acceptable date formats

Several fields in the Argus Safety user interface enable you to enter dates. Fields that accept full dates appear in the dd-mmm-yyyy format.

Appropriate formats for entering English dates are as follows:

- DDMMMYYYY where MMM is the three-character abbreviation for the month (such as MAR, APR, JUN, and so on.)

- DDMMMYY where MMM is the three-character abbreviation for the month and YY is the two-digit numeric value for the year (such as 09, 10, and so on.)

- DDMMYYYY where MM is the two-digit value identifying the month (such as 01 = January, 02 = February, etc.) and YYYY is the four-digit value for the year.

The dot (.), dash (-) and backslash(/) are acceptable separators.

1.7 Use other (than English) language text

Certain fields on the Case Form let you enter text in languages other than English. The non-English text that is entered in these fields can also appear on Expedited reports.

To enter text in a language other than English:

1. Click the English language icon.

2. Use the pane associated with English to enter the English language text. Select the required language from the Select Language drop-down list to enter text in that language.

3. After completing text entry, you can perform a spell-check for the text.

The table below displays icons representing different languages.

Icon

Language

English

Japanese

Language other than English or Japanese

1.8 Enter reasons for missing (Null Flavor) data

Null Flavors are used to describe the reason for missing data. ICH E2B(R3) and regional agencies such as CBER, EMA, MFDS, and PMDA have published guidelines on the allowed Null Flavors for various fields that are part of the E2B(R3) report. A Null Flavor set is a collection of Null Flavors. Sets are provided by default for various combinations of Null Flavors in the Flexible Re-categorization Codelist.

Null Flavor data can be selected for fields in the Case Form by clicking on the Null Flavor button ( ) next to the fields. On clicking the button, a drop-down list appears and allows you to select Null Flavor data as configured in the Field Properties Configuration in the Argus Console. The background color of the NF button changes (from grey to blue) when a Null Flavor is selected from the drop-down list.

When the Case Form field has data and the user clicks the button, the system displays a warning message that data will be cleared on switching to the Null Flavor field. The data is cleared or retained based on user confirmation. When data pertaining to the field is received, Null Flavor data can be overwritten by actual data by clicking the NF button.

1.9 Log out

- In the upper-right corner of any page, click Logout.

1.10 Dynamic workflow indicator

Dynamic workflow indicators track the amount of elapsed time it takes to complete a workflow step.

- The first number represents the time left or exceeded for a given workflow step.

- The second number indicates the time left until the reporting deadline.

- Time is expressed in days (d), hours (h), and minutes (m) respectively.

The icon changes based on the amount of elapsed time for the workflow step.

Icon

Denotes

Traffic Light

No status can be indicated. For example, when no timing is defined in the workflow.

Red Traffic Light

The timing has been exceeded.

Yellow Traffic Light

The timing is in danger of being exceeded.

Green Traffic Light

The timing is in good standing.

If the time to complete the case process exceeds the allocated time, the value is displayed in red with the time displayed as a negative value. Only archived, locked cases do not display the dynamic workflow indicator.

1.11 Integrate with Argus Insight

Argus Safety has the following integration points with Argus Insight. All these integration points operate within the same enterprise for both Argus Safety and Argus Insight.

Note:
This integration is available only to Argus Enterprise Edition users.

- Case Series Sharing: In case of multi-tenant installations, Argus Safety > Case Actions > Case Open screen > Result from Argus Insight imports the active case series for the user from the same enterprise partition of Argus Insight which is currently opened in Argus Safety.

- Argus Insight Application Launch: The Argus Insight button in the main Argus Navigation bar opens the same enterprise partition of Argus Insight which is currently opened in Argus Safety.

1.11.1 Sharing a case series in Argus Safety with Argus Insight

1. In the Case Search dialog box, search for and select a case in Argus Safety.

2. Open Argus Insight.
The system writes the case series belonging to the alert to the Argus case-sharing table.

3. Check Make Active from Argus to make the Case Search dialog box case series active in Argus Insight.

4. If Argus Insight was already open, the Active Case series in Argus Insight is replaced with cases from Argus.

1.11.2 Sharing a case series in Argus Insight with Argus Safety

A case series can be made available from Argus Insight through Active Case series. To share a case series in Argus Insight with Argus Safety:

1. Hover over the Case Actions menu and click Open.

2. Click Result from Argus Insight to create a search result with the same cases as the Active Case series in Argus Insight.

1.12 Case form user preferences

The application lets you return to the same location on the tab after you tab to a different form. For example, you are on the 8th reporter in the Reporter Section on the General tab and move to another location in the application. When you return to the General tab, you are automatically directed to the 8th Reporter as it was the last Case Form location that you accessed before moving out of the Case Form.

User preferences are only applicable during the same session for a case, irrespective of the case status (read-only or editable). If you exit from the case and open a new case, the user preferences are reset.

Quick navigation

Each page displays the navigation flow to access the page.

Shortcut Key

Output

CTRL+SHIFT+#

Directs to the tab indicated by the # entered. (1=General tab, 2=Patient tab, etc.)

ALT+SHIFT+#

Directs to the sub-tab as indicated by the # entered (= Product 1, Product 2, etc.)
Note: The maximum # for the sub entities is 10 which pertains to ALT+SHIFT+1 for the first entity within the tab till ALT+SHIFT+0 for the 10th entity within the tab.

1.13 FAQs

1.13.1 Why can't I access Argus Safety?

You may not have set up the compatibility view in Internet Explorer.

1. Open Internet Explorer and press the Alt key on your keyboard. The menu bar appears.

2. Click the Tools menu and select Compatibility View settings.

3. Enter the URL for Argus Safety.

4. Click Add and then click Close.

1.13.2 What happens if I enter a wrong password?

The password is case-sensitive.

If you enter an incorrect username or password three consecutive times, based on the current settings, Argus Safety then performs one of the following:

- Disables the Login button and displays a warning message.

- Locks your account. If this occurs, you must contact your company Administrator to unlock your account. If you are still unable to login, please contact My Oracle Support.

Note:
The application sends an email for Invalid Log-in entries to a pre-configured email address that specifies the username used for Login along with the terminal from where the user tried to login to the system.

Tip:
If you still cannot log in and you do not receive the Login Error dialog box, verify that the Pop-up Blocker functionality is disabled for your browser.
Internet Explorer is the only certified client-side web browser for use with Argus Safety.

1.13.3 Why can't I change my password?

You may have exceeded the number of wrong entries. Ask your Administrator to reset your password.

If you are logged in and the password change has not been accepted, hover over the Utilities menu and select View the Error Log under Logs for details.

1.13.4 How do I get help?

To get task-based help, click Help on the top-right frame of the window. This takes you to the respective product page on Oracle Help Center.

To get field-level help on the Case Form, double-click the label associated with the field to obtain information about that field.

2 Enter case data

2.1 Create a new case

When your company receives new adverse event data, you need to enter this information and check for duplicates before saving a case in Argus Safety.

You can create a new case by doing either of the following:

- Select Case Actions, and click New.

- Select Worklist, and click Intake.

2.1.1 Enter a new case

From the Initial Case Entry form, you can decide to book in a case before entering further case information in the Case Form.

To enter a new case:

1. On the Home page, hover over the Case Actions menu and click New.

2. On the Initial Case Entry page, enter the mandatory information (fields with a red flag) and click Continue.

3. Click Search to confirm this is not a duplicate case.

4. A list of cases that match the criteria you entered on the form is displayed. Review the search results for a duplicate case.
If a duplicate case exists, open the case to enter further information related to the existing case. Click the link associated with the case.

5. If a duplicate case does not appear, click Continue in the Initial Case Entry form to display the BookIn and Attachments and References sections.
When a duplicate search is performed, the system remembers the results until the user logs out of the system or performs a duplicate search again. When the Bookin screen is opened, the search results from the last search are displayed again.

6. Enter the relevant information in the following sections:

- Under Reported Causality, select the reporter's assessment of causality. The causality relationship is the causal relationship between the clinically most important event and the suspect drug that is entered in the Initial Case Entry form.

- For Seriousness Criteria, check the appropriate checkboxes to indicate the seriousness of the case, as appropriate.

- Attachments and References

- To insert a file attachment
1. Click Add on the Attachments and References tab.

2. Enter the Classification and Description, as applicable. Select File Attachment from the drop-down list and click Add.

3. On the File Attachment -Web page dialog box, double-click Browse and navigate to the relevant file. Click B.

Contact your system administrator to configure this location.

- To insert a URL Reference
1. Select URL Reference from the drop-down list.

2. Enter the URL after http://.

- To search for and insert a document
1. Select Documentum Link and click Add.

2. The Document Lookup dialog box is displayed.

You can search for a document from the database by specifying a search criterion in this dialog box.

7. Click BookIn.
Once clicked, this button is hidden from the screen. The button is enabled only if the Save operation fails or when the case is booked-in successfully.

8. If Argus has been configured to generate a case number automatically, it is generated now.
If the case number is not automatically generated, enter it according to your company guidelines.

9. When the case creation message appears, click Yes.
Note: If you click Yes, the Case Form page appears. You can now enter case data.

If you click No, the case is saved and closed. You can open the case and enter data at any time.

2.1.2 Initial case entry—fields descriptions

Field

Description

Initial Receipt Date

Enter the complete date on which your company became aware of the case. The Receipt Date cannot be entered as a partial date.

Central Receipt Date

Enter the date on which this information was received by Central Safety.

Country of Incidence

Select the country where the adverse event occurred. This may or may not be the reporter's or the patient's country of residence.

Report Type

Select the item that best describes the type of report. This determines the fields that are made available for entering case information.
The report type also impacts duplicate search. For example, selecting Sponsored Trial makes the Study ID and Protocol ID fields available. The Administrator can adjust the information in this list.

Study ID(applicable to clinical trial cases only)

Click Select to choose the study ID from the Clinical Trial Selection dialog box.

Center ID
(applicable to clinical trial cases only)

Click Select to choose the Center ID from the Clinical Trial Selection dialog box.

Initial Justification

The values of this field are configurable through the standard Argus Justifications dialog box. This field is reflected in the General tab of the Case Form and is also available for duplicate searching for cases.
Click the green dot to view and select justifications from the Argus Justification dialog box.

Product Name

If the adverse event(s) are associated with more than one product, each additional product can be added from the Case Form.
Enter the most suspect product here. Click Select to search for a product from the Trade Name Product Lookup dialog box. Several items are automatically entered on the Case Form based on the product selected here.

Generic Name

This field can be used to enter the generic name of the product. This field is automatically entered when a product is selected from the Trade Name Product Lookup dialog box.

Description as Reported

Enter a brief verbatim description from the reporter describing the event that is most clinically important in the case. The icon denotes that the event is encoded. Click the icon to populate the MedDRA hierarchy dialog box.

Onset Date/Time

Enter the date/time for the onset of adverse event symptoms.

ID

Enter the value to search for a Reporter Reference number, Case Reference, and Case number.

Journal and/or Title

These items are applicable to literature cases only. Click Select to choose a journal and/or title from the Literature Reference dialog box. The Administrator can adjust this list.

2.1.3 Check for duplicates

1. Enter the information related to the case in the Initial Case Entry form.

2. Select the Receipt Range Limits option to check for duplicates based on the dates entered in the form and click Search.

3. Review the list to determine if any case contains duplicate information.

2.1.3.1 Receipt range—fields descriptions

Field

Description

No date

90 days before System Date and 2 days after System Date.

Full Onset Date

10 days before Onset date and 90 days after Onset Date.

Full Initial Receipt Date

60 days before Initial Receipt Date and 60 days after Initial Receipt Date.
Note: This default date range for searching on Initial Receipt Date can be disabled by un-checking the Receipt Range Limits option on the Initial Case Entry dialog box.

Partial Onset Date

Based on the Full Date Range - if only the year is entered, the date range becomes: 10 days before the end of the previous year and 90 days after the end of the year.

Partial Initial Receipt Date

Based on Full Date Range - if only a year is entered, the date range becomes: 60 days before the end of the previous year and 60 days after the end of the year.

Note:

- If an Initial Receipt Date is not entered but an Event Onset Date has been entered, the search will default to look for cases with Initial Receipt Dates 10 days before and 90 days after the Event Onset Date. This feature can be disabled directly on the dialog box by un-checking the Receipt Range Limits checkbox. If you do not check anything, the default date range is 90 days before and 2 days after the current date.

- The Duplicate Search permits you to sort in ascending or descending order in the duplicate search results. You can also use wildcard searches on all text fields in the Book-in dialog box.

2.1.4 Initial case entry—BookIn dialog box

- You can enter the attachment classifications and their descriptions on the Initial Case entry dialog box.

- The values entered in the Classifications and Description fields are transferred after the cases have been booked.

- When you book in a clinical trial case and select a study where the country of incidence value does not match the list of countries defined in the study configuration, a warning message appears.

- Right-click the row, and select one of the following:

- View Case Summary

- Print Medical Summary—Displays the Medical Summary report PDF. If you do not have access to the Medical Review dialog box, the Medical Summary Report is hidden.

- Print—Launches the Case Form print dialog box. If you do not have access to the Case Form print dialog box, the Print Case option is hidden.

2.1.5 Accept incoming cases

The Intake function enables you to view a list of incoming attachments in the Worklist View where you can select an attachment for creating a case.

To access the Worklist > Intake page, hover over the Worklist menu and select Intake.

2.1.5.1 View pending case

Use Pending tab to create a case, reject a case, and so on. Users other than Workflow Managers can reject a case from the Intake Worklist.

Field

Description

Priority

Allows the user to view the priority of the case.

Case Type

Allows the user to view report type information.

Reporter Type

Allows the user to view the Reporter type for the Primary Reporter in the case.

Group

Allows for the current group owner or Unassigned group to be assigned to the case.

Central Site/LAM Site

Allows the user to view the current Site (Argus or Affiliate) of the Case - If there are no Sites defined, ALL users can access the case attachment.

Attachment Name

Allows the user to view the attachment which is associated to the case.

Classification

Allows the user to view the attachment classifications which is associated with the case.

Description

Allows the user to view the attachment description which is associated with the case.

2.1.5.2 View rejected cases

Field

Description

Generic Name

Allows the user to view the generic name of the suspect product in question.

F, LT or H

Allows the user to view Fatal, Life-Threatening or Hospitalized cases.

Reporter Type

Allows the user to view the Reporter type for the Primary Reporter in the case.

Country

Allows the user to view the Country of incident.

Classification

Allows the user to view the attachment classifications which is associated to the case.

Description

Allows the user to view the attachment description which is associated to the case.

Rejected Date

Allows the user to view the date when the case was rejected.

2.2 Enter general information

The General tab captures the case information in categorized sections for category-specific information. It also enables you to enter or view information such as the type of report, literature information, and so forth.

- If a priority has not been assigned to a case, the Case Priority field is hidden.

- If a case owner has been assigned to the case, the name of the case owner appears at the top of the Case form.

2.2.1 General information—field descriptions

Field/Control Name

Description

Report Type

Select a report type that determines the availability of fields relating to clinical studies and literature references.
The Clinical Study report prompts for information relating to the study, and literature-based reports enable to select the journal and reference on which the case is based.

Country

Select the country where the adverse event occurred.

Initial Receipt Date

Enter the date your company became aware of the case. Argus Safety uses this date throughout all reports.
This date can be changed only prior to regulatory report submission.

Central Receipt Date

Enter the date on which this information was received by Central Safety.

Medically Confirm

Specify whether the case was medically confirmed or not, by a healthcare professional.

Initial Justification

Enter the initial justification reason.
The entry in this field is displayed as per the reason entered when the case is being booked in.

Amendments/Follow-ups

On sorting by Follow-up received dates, the serial number still displays the order of entering the follow-ups. The follow-up information can be sorted by:

- Serial Number

- Follow-up Received Date

- Central Received Date

Click the header to sort in ascending or descending order. By default, the sorting is in descending order of the Follow-up Received Date.

Follow-up Received Date

To enter the date on which amendment or follow-up information was received by your company, click Add.
You can select whether the case has significant follow-up information by confirming the message: Is this follow-up significant?.

When sorting on follow-ups, by default, the dates are sorted in descending order.

Safety Received

Enter the date on which follow-up information was received by Central Safety. This field is disabled for an amendment and any prior data in this field is cleared.

Significant

Check this checkbox if the follow-up is significant.

Data Clean up

Check this checkbox to mark the follow-up as a Data Clean up version.
This version is used in the Data Lock Point for Case Versioning in and System Reports.

This field is disabled for an amendment and any prior data in this field is cleared.

Amendment

Specify if the case was updated without adding any new information.
This checkbox is enabled irrespective of whether the Significant checkbox is checked.

Amendment/Follow-up Justification

Select a pre-defined justification for Amendment or Follow-up.
Click the icon to view the standard justifications dialog box. The justification entered in the Amendment field is also populated in this field.

You can select a pre-defined justification from this dialog box or enter a new justification.

Case Requires Follow-up

Check this checkbox if the case requires follow-up information.

Classification

Select up to 50 case classifications used to categorize a case.
To enter additional case classifications, click Add.

When the Classifications field is hidden, the classification section is hidden on the Case Form

2.2.2 Enter study information

1. To choose from the available list of study information, click Select.

2. In the Clinical Trial Selection dialog box, enter Project, Study, and Center information.
The Clinical Trial Selection dialog box allows you to select a clinical trial from the list configured by the administrator.

3. Click Search.

Tip:
To broaden the search results, enter as little information as possible. Select the required clinical study and study center, and click Select.

4. Choose the study information from the list, and click Select.
The details of the selected Study Information are added to each field in the Study Information section.

2.2.2.1 Study information—field descriptions

Field/Control Name

Description

Project ID

Enter the Project ID, or select one from the list.
Selecting a Project ID automatically creates items in the Study ID list.

Study Phase

Enter the Study Phase for the configured study.
This field is pre-populated if you select a Study with an already-configured Study Phase.

Blinding Status

The status is auto-populated based on the type of study.
You need special access rights to use any of the Broken By entries.

Note: The Unblind Case dialog box appears when you try to unblind a study. For Not Blinded studies, saving the case or generating a report, you can enter the actual drug (vs. placebo) given to the patient.

Observe Study Type

The value selected from this drop-down list is populated in the Case Form Study Section when the Clinical Study is selected.

Unblinding Date

Auto-populates when the blinding status is changed to 'Broken by Sponsor' or 'Broken by Investigator'.
If you double-click the date in this item, the Unblind Case dialog box is displayed. If the date of unblinding is more recent than the date for the most significant follow-up information, an automatic follow-up is generated.

The unblinded date is not editable in the Unblind case dialog box when blinded status is changed to 'Broken by Sponsor' whereas it is editable when the blinded status is changed to 'Broken by Investigator'.

2.2.3 Enter reporter information

Enter the information about the person providing the case-related information.

- The Reporter Rearrangement dialog box displays the number of Reporters present in the case. It displays the First Name and Last Name, followed by the Reporter Type in brackets, as entered in the reporter information dialog box.

- To view all the Reporters, click the Quick Launch icon.

- To view the details of the selected Reporter tab, click a Reporter Name.

- To add a new reporter, click the New tab. You can add a maximum of 100 reporters.

- The Primary Reporter is identified by the Reporter icon on the Reporter Information tab.

2.2.3.1 Add reporter information

1. In the Reporter Information section, click Select.

2. In the Reporter Lookup dialog box, enter the search criteria, and click Search.

- All filter criteria you have entered on the Reporter Look Up dialog box are saved as user preferences while it populates the reporter information on the General tab.

- If you have reporter information in the case, the information appears in the Reporter Lookup dialog box and search is performed.

- After performing the search the search criteria is retained as user preferences. The next time you perform a search, these preferences appear.

- When you log out, the user preferences are retained and are available the next time you log in.

- To clear all the values in the filter elements, click Clear.

Tip:
You can choose to search either by Search Cases or by Search List Maintenance.

3. From the search results, select the reporter information, and click Select.
The selected, pre-defined information is added to the fields.

2.2.3.2 Reporter information—field descriptions

Field/Control Name

Description

Reporter Notes

Click this button to enter free text notes relating to this reporter.
This field supports multiple language entries. Click a flag, select the language tab, and enter information.

Institution ID

Enter the reporter's institution ID.
This field value is populated based on the Institution ID selected for the Reporter from the Reporter Lookup dialog box. This field also allows to manually enter or update the value directly in the Case Form irrespective of the value specified in the Institution field for the reporter.

Manually entered Institution and Institution ID field values are allowed in the Reporter Information section even if they are not specified or linked to each other as per Console Institution code list.

Protect Confidentiality

If this checkbox is checked, the name and address of the reporter does not appear on regulatory reports and the reporter's information displays "NAME AND ADDRESS WITHHELD".
The 'MSK' null flavor appears in the eVAERS report when this checkbox is checked. MSK is populated only when the data element contains some data and is not null.

Primary Reporter

Only one primary reporter is permitted per case. The primary reporter is the reporter whose name appears on the regulatory reports. The tab that identifies the primary reporter is displayed in blue as compared to the other reporter tabs.

Correspondence Contact

If this checkbox is checked for a reporter, the reporter's address information is used in letters. You can select more than one reporter as the correspondence contacts for the case.

Reporter ID

If known, enter the Reporter ID. This completes the Case Form reporter fields.

Reporter Type, Report Media, and Intermediary

These lists are maintained by the administrator.

(New) Tab

Creates details for a new reporter.

2.2.4 Enter literature information

You can enter a literature reference for a case manually or you can enter pre-defined literature information.

1. From the list of available literature, click Select.

2. In the Literature Reference dialog box, select a reference in the list, and click Select.
The details of the selected literature information are added to each field in Literature Information.

2.3 Enter patient information

You can enter patient information such as the patient's past medical history and current conditions, and laboratory tests and test results.

2.3.1 Enter current medical status

1. In the Case Form > Patient tab, click Current Medical Status.

2. From the items in the form, select the options that apply to the patient.
If you don't know whether a particular condition applies for the patient, select Unk.

3. To save the current medical status, click OK.

2.3.2 Copy patient information from reporter information

If the patient and the reporter are the same person, the reporter information entered in the General tab can be copied to the Patient tab.

To copy the reporter information, click Patient Info From Reporter.

2.3.3 Patient information—field descriptions

Field/Control Name

Description

Child only Case

If this checkbox is checked, then the pregnancy [Detail] button is accessible from the Parent information tab only and no longer through the Patient tab directly.

Current Medical Status

Captures details about the history and the current condition of the patient from the dialog box.
The items that appear in the Current Medical Status dialog box are mapped to the fields for the German BfArM tab on the Analysis tab. Changing the values on the BfArM tab does not affect these items.

Name
(Title, First Name, MI, Last Name)

During book-in, the patient name is transferred to the relevant name and initials fields. If the Patient Name or Initials are three characters or less, this is transferred to the Initials field.

Number of Patients

Enter the number of patients involved in the adverse event.

Pat. ID

Enter the Patient Identifier number.
Note: This field appears for clinical trial cases only.

Tip: This field can be used while searching for cases in the Case Selection dialog box.

Protect Confidentiality

If this checkbox is checked, the patient's name and address will not appear on any of the regulatory reports and the patient's information will show the word PRIVACY.
The 'MSK' null flavor appears in the eVAERS report when this checkbox is checked. MSK is populated only when the data element contains some data and is not null.

Randomization #

Determines which drug was administered to the patient during the course of the study.
Note: This field appears for clinical trial cases only.

Tip: This field can be used while searching for cases in the Case Selection dialog box.

Sponsor Identifier

Enter the Sponsor Identifier of the patient.
Note: This field appears for clinical trial cases only.

Tip: This field can be used while searching for cases in the Case Selection dialog box.

2.3.4 Enter patient notes

Click to enter free text notes relating to the Patient. If there is no text data for Patient Notes, from the NF drop-down list, select Null Flavor.

Note: This field supports multiple language entries. Click a flag icon to enter data in different languages.

Icon is displayed when there is no data in Patient Notes and NF data.

Icon is displayed when there is data in Patient Notes or NF data.

2.3.5 Enter patient details

Enter patient information, including pregnancy data.

Table 2-1 Patient Details—Field Descriptions

Field

Description

Ethnic Group

Enter the patient's ethnic group such as Hispanic or Latino, Not Hispanic or Latino, and so on.

Military Status

Enter the details of the Military status of the Patient such as Active Duty, Reserve, National Guard, TRICARE Beneficiary, and so on.

Race

Select the patient's race. You can capture up to 5 Race using the Add and Delete buttons.

Note: You cannot select the same Race more than once.

Pregnant at time of Vaccination

Select Yes if the patient is pregnant at the time of vaccination.

2.3.5.1 Enter pregnancy information

1. From the Pregnant drop-down list, select Yes.
This field is shown as active only after the Gender field in this section is selected as Female.

The Pregnancy Information section appears.

2. Enter the available pregnancy information in the form.

3. Click OK.

4. In the Neonate Information section:

- To delete neonate information, right-click the neonate, and click Delete.

- The changes are tracked to the neonate information in the audit log.

The following list describes the fields on the Pregnancy Information and Neonate form.

Field/Control Name

Description

Gestation Period

Enter the gestation period when the reaction or event was observed in the fetus. Select a unit for the gestation period from the accompanying drop-down list.

Number of Fetus

Enter data for a baby who is born to the patient.
To make an additional entry, click New.

Prospective/Retrospective

Select if the information was Prospective or Retrospective.
A prospective information is one where the company hears of the case before the baby is born to the patient who took the drug.

In a retrospective case, a company gets to know after the baby is born.

2.3.6 Enter patient death details

Enter information about the death of a patient.

2.3.6.1 Event death details—field descriptions

Field/Control Name

Description

Autopsy Done?

If Autopsy Done is set to No or Unknown, the Autopsy Results Available is shown as No.

Autopsy Results Available?

The Autopsy Results Available? field is enabled only if the Autopsy Done? field is marked as Yes.
If Autopsy Results Available? is changed to No, and Autopsy Result rows exist, you will be asked to delete the rows first. Click Yes to delete the data.

Add

Click this button to add a Cause of Death and Autopsy Results row.
Note: You can add multiple records, up to 50 entries.

Delete

Deletes a highlighted row.

2.3.7 Enter other relevant history

Enter information related to past drugs administered on Patient, and Current Medical condition of the patient.

To copy the Other Relevant History rows, select the row, and click Copy.

2.3.7.1 Other relevant history—field descriptions

Field/Control Name

Description

Copy

Enables you to copy a row. After you copy the row, the focus will be on the newly copied row.

Add

Enables you to add a row to the relevant history. After you add the row, the focus will be on the new row.

Delete

Enables you to delete a row from the relevant history.

Start Date

Enter the start date of the condition. You can enter a partial date if the actual date is not available. You can also choose not to enter a date.
Note: If you click Add but do not enter a date, the Date column is removed.

Once the date is entered and a test is associated with the date, you cannot clear the date but can only modify it. To remove the date column, individually delete all the cells in that Date column.

Stop Date

Enter the stop date of the condition. You can enter a partial date if the actual date is not available. You can also choose not to enter a date.
If you select Ongoing as Yes or Unknown, the Stop date is cleared and disabled.

Age and Units

Age and Age units are enabled only for condition type with Patient Other Relevant Therapy being set.

Family History

Check this checkbox if this relevant history is reported to be present in another family member. The Family History checkbox is enabled only for Condition types that are mapped to &rsquor;Medical History Episode' in the Condition Type codelist.

Substance Information

Displays the substance name, term ID, and strength unit of the Product separated by commas. If there are multiple records, they are displayed in subsequent rows.

Name Part

Displays the name part and name part type information. If there are multiple records, they are displayed in subsequent rows.
Click Name Part button to enter Product Name Part Type and Product Name Part details.

Product Name Parts Information

Displays the Product Name Part information. Enabled only for condition type with Patient Other Relevant Therapy being set.

Version

Displays the Date or Version of the Product Identifier. Enabled only for condition type with Patient Other Relevant Therapy being set.

Coded PT/Description of condition LLT/Indication PT/Reaction PT

Enter a term to describe the condition. You can either manually encode or auto-encode if you have been so configured by the Administrator.
In manual mode, type the description (for example, Fever).

In Auto-encode mode, enter a partial description and press ENTER or TAB.

The appropriate coding dialog box appears.

In either mode, click Encode and modify the encoding. If the condition type is historical drug, the encoding will be done with WHO drugs.

Product Identifier Type/ Product Identifier Version/MFDS Product Code/WHO Medicinal Product ID/Notes

Displays the type of Product Identifier such as MPID, PhPID, and so on. Enabled only for condition type with Patient Other Relevant Therapy being set.
Displays the Date or Version of the Product Identifier. Enabled only for condition type with Patient Other Relevant Therapy being set.

Enables you to add the MFDS assigned Product Code.

Both MFDS Product Code and WHO Medicinal Product ID fields are enabled only when the Condition Type is set to value configured for Patient Other Relevant Therapy as Yes in Codelist > Condition Type.

These fields are disabled, when the Condition Type is set to value configured for the Medical History Episode as Yes in Codelist > Condition Type.

When drug is encoded using the WHO-DD C3 format then the Medicinal Product ID is populated in the WHO Medicinal Product ID field. If the drug is encoded but already has a value entered in the WHO Medicinal Product ID field, then the value from the Drug Coding browser is overwritten into the Medicinal Product ID field.

When the drug is encoded using any other WHO-DD format where the Medicinal Product ID is not available or displayed in the Drug browser, then the Medicinal Product ID is not populated in the WHO Medicinal Product ID field and remains Null. If you have entered any data in the WHO Medicinal Product ID field, then it is removed when drug is encoded using any other WHO-DD format where Medicinal Product ID is not available.

Encode

Click this button to encode the term. Encode is used in multiple contexts such as coding with MedDRA for reactions and indications, and coding for products using WHO drug browser.
Note: To view the complete MedDRA hierarchy for the encoded term, click the encoding status icon.

Indication PT and Reaction PT

This field is visible on the case form only if the condition type selected in the List maintenance is Patient Other Relevant Therapy.

Ongoing

Indicates whether the condition is continuing. If it is set to Yes or Unknown, the Stop date is disabled.

2.3.8 Enter lab data—lab test and test results

The maximum number of lab test data on the Case Form is 1500.

1. To enter a Lab Test Name:

1. Click Add Test.

2. Enter the description, and click Search.

3. From the search result, select a name.

2. To select a Lab Test Group, click Select.
A list of the lab test that matched the selected group appears.

If lab test data is already in the case form, the lab test group is appended after the last lab test.

3. To add more rows of Lab Test Data, right-click an empty cell, and click Add.

4. To copy a Lab Test Data, right-click the row to be copied, and click Copy.

5. To delete a Lab Test Data, right-click the row to be deleted, and click Delete.

6. To arrange entries in a specific order, click the Order icons.

7. You can sort Lab data in chronological order by Date of the Test and alphabetically by the Test Name.
If there are partial dates entered, the date is displayed at the beginning of the month, and year for the date entered.

8. To view the hierarchy of the Event Term, click the view icon.

9. To view Notes in a Zoom dialog box, click the view icon.

10. To arrange the Lab Test Data, click the arrow button to move data to left or right.
This is available only when the Lab Test is entered for the same date.

2.3.8.1 Lab data—field descriptions

Field/Control Name

Description

Norm Low/Norm High

The Test Name list can retrieve details of the normal range for the test selected (if the administrator has entered the normal range into the list). Otherwise, enter the values manually.

Result/Units

Enter the test result, including units, and select a term to describe the qualitative assessment of the results. The administrator can modify the list of possible assessments.
If test results cannot be expressed in Result/Units or Assessment, enter the data in Notes field.

You must enter Lab test result by using Results/Unit, Assessment or Notes fields, and not in all the fields. Regulatory agencies may send rejection for ICSR if data is sent in all formats.

Assessment

Select a qualitative assessment term to describe the lab test results.

More Info Available

Check this checkbox if there is additional information is available for this Lab test in Additional Info tab.

2.3.9 Enter additional test information

Enter additional information about any relevant tests, such as toxicology.

2.3.10 Enter parent information

The Parent Information tab is similar to the Patient tab.

However, in the Other Relevant History section, the Family history, Age, and Units fields are unavailable.

2.4 Enter product information

Enter and view details for products and dosage regimens. This tab contains the name of the drug that has been entered here. For Blinded Studies, the Blinded Product Name field appears in the tab.

If you do not have access to view unblinded information on the Case Form, some of the fields are hidden.

If the study has been unblinded and a study drug had been selected, the selected Study Drug Name is displayed. You cannot view unblinded information and the tab continues to show the Blinded Product Name.

You can enter details of more than one product and more than one dosage regimen for a company product for which multiple licenses exist (for example, drug and vaccine, or drug and device).

Based on the type of license (drug, vaccine, or device), different views are available in the Products tab. If the selected item is not a company product or if a license for a company product does not exist, all three views are always available.

2.4.1 Search for products

2.4.1.1 Product Browser based search

1. In the Products tab, click Select.
The Product Browser dialog box appears.

2. Click the displayed entities.
The hierarchy above and below the entity being searched is also displayed. For example, if Product Name is searched, it displays the Product Name as well as the Family Name and Trade Name.

3. Search for Products based on the following criteria:

- Ingredient

- Family

- Product Name

- Trade Name—Searches the License Trade Name

4. To select all the search criteria, select the Full Search checkbox, and click Select.

5. Select a product from the search result.

6. To remove the entered search criteria, click Clear.

2.4.1.2 WHO Drug Browser based search

1. To open the WHO Drug Coding dialog box, click Encode.

2. From the Case Form Configuration dialog box where the Dictionaries are selected for encoding, select either the WHO Drug B format or the WHO Drug C format.

3. Enter the search criteria, and click Search.
You can search for a product based on:

- Trade Name

- Formulation/Strength (sequence 3 and sequence 4) of the product

- Country—The Sales Country Code of the Product as defined in the WHO Dictionary

- Generic.
The following criteria are not available for display or searching in the WHO Drug B Format:

- Formulation

- Country

- Strength

- Generic

- Medicinal Product ID

- Product Type

4. To copy the selected drug to the Product tab, click Select.

5. To close the selection dialog box without making any updates to the Product tab, click Cancel.

6. To perform a full search from the WHO Drug browser, select Full Search.

- By default, a like search is performed (e.g., CUREALL%)

- You can use the percent (%) sign to perform wildcard searches

- If you click Full Search, the full search is performed (e.g., %CUREALL%)

7. You can also search for drug formulation and country. This option is available only if you select the WHO Drug C format.

8. To clear the search criteria you entered, click Clear.

9. You can sort the results on all the fields.

2.4.2 Enter time measurement information

You can enter seconds in the following fields:

- Argus > Case Actions > Open > (Select a Case) > Event tab > Event sub tab > {event description} sub tab > Event Information section (middle of screen)

- Onset From Last Dose field

- Duration field

- Onset Latency field

- Argus > Case Actions > Open > (Select a Case) > Products tab > Product sub tab > {Product Name} sub-sub tab (drug) > Dosage Regimen section (lower 1/3 of screen)

- Duration of Regimen

- Argus > Case Actions > Open > (Select a Case) > Products tab > Product sub tab > {Product Name} sub-sub tab (drug) > Product Details section (lower 1/3 of screen

- Duration of Administration

- Time between First Dose/Primary Event

- Time between First Dose/Primary Event

- Any number following by the letter "s" defaults to "#sec."

- The seconds entered in the form are interpreted in the following formats, where:
# is a number from 0 to 9

#s—changes the format to # sec.

# s—changes the format to # sec.

# sxx

where:

x is other letters—that changes the format to # sec

- The Temporal View and the Case Form printout display the seconds.

- The E2B import and export case functions support seconds and M2 Validation for the defined fields.

2.4.3 Enter drug information

2.4.3.1 Product information—field descriptions

This section enables you to enter information about the drug being used for the case.

Field/Control Name

Description

Product Information

Product Name

Enter the name of the product using the Select button or by entering a partial product name. Type a partial product name and press TAB. This displays the Product Selection dialog box.
If only one product is found, this information is entered without showing the dialog box. If no match is found in the company product list, the WHO Drug Dictionary is searched for a possible match through the WHO Drug Dictionary dialog box. If a match is still not found, the text you initially typed in, is used as is.

Note: If the study is blinded, the Blinded Name of the clinical study is displayed in this field. After unblinding, the selected study's Product Name for Unblinded cases is not shown.

Select

Displays the product selection dialog box.
Select a product from the list of company products click Select.

The relevant fields are added to the Case Form.

Encode

Click Encode to retrieve the code.

- Suspect

- Concomitant

- Treatment/Other

Make a selection for the product you are entering. The drug types indicate the involvement of the product with the adverse event(s) reported for the case.
Suspect indicates that the product may have caused the adverse event(s).

Concomitant indicates drugs that are taken with the suspect drug.

Treatment/Other is the drug taken to treat the adverse event.

Generic Name

Enter the generic name of the drug in a manner similar to the Product Name. If the study is blinded, the Generic Name is replaced with the Study Name of the product.
Note: This name is entered based on the selected company product.

If the study is blinded, the Blinded Name of the clinical study is displayed in this field. After unblinding, the selected study's Product Name for Unblinded cases is not shown.

Product Identifier

Displays the type of Product Identifier such as MPID, PhPID, and so on.

MFDS Product Code

Enables you to enter the MFDS product code for the drug.
This field is treated as a blinded field.

OTC Product

Check this checkbox if the product administered was an over-the-counter (OTC) product.

Compounded Product

Check this checkbox if the product administered was compounded.

Company Drug Code

Displays the licensed country for the selected company product.

Obtain Drug Country

Country the drug is licensed in.

Drug Code

Enter the WHO-DRUG code.

WHO Medicinal Product ID

Displays the Medicinal ID associated with the selected WHO drug. The WHO Drug code used to identify the drug.
Note: This ID is populated only if a WHO-drug is selected.

Formulation

Select the formulation of the product. The form in which the drug was administered (liquid, tablet, capsule, and so on.)
Note: This field is entered based on the product. Contact your administrator to adjust this list.

Drug Authorization Country

The country where the drug is licensed.

Market Authorization Holder

Captures the name of the Marketing Authorization Holder of the product that was administered.

Authorization Type

Captures the Authorization Type of the product that was administered such as IND, BLA, PLA, and so on.

Authorization Number

Captures the Authorization Number or License Number of the product that was administered.

Authorized Representative

Select a manufacturer name from the manufacture codelist.

Manufacturer

A different Manufacturer can be selected from the drop-down list and can still be kept as a company product.

Concentration

Indicates the amount of the drug that was administered.
After a drug and formulation have been entered, select the concentration from the list, or enter the concentration.

If this information is changed manually, the product is marked as a non-company product.

Note: This field is entered based on the chosen product. The concentration cannot be modified for a Study drug.

Interaction?

Indicates whether the case involves a drug interaction.

Contraindicated?

Indicates whether the drug was administered contrary to its indication.

Drug Not Administered

Check this checkbox if no drug was administered on the patient.

Substance Information

Substance Name

Displays the Ingredient's name.

Strength

The Strength of the substance used in the Product.

Unit

The drug unit (such as mg, tsp, and so on).

MFDS Ingredient Code

Enables you to enter the MFDS ingredient code for the drug.
This field is treated as a blinded field.

Note:
Drug Authorization Country, Authorization Type, Authorization Number, and Marketing Authorization Holder data are populated from the Argus Console for company products.
For Study Products, the system populates the Authorization Type, Authorization Number, and Marketing Authorization Holder data based on the Primary license number selected in the Argus Console > Studies Configuration. When unblinded at the case level, Authorization Type and Authorization Number data is not accessible for users with restricted access to unblinded data.

2.4.3.2 Enter product indications

Enter information about the indicator of the adverse event, like:

- Reported Indication—Reported reaction

- Coded Indication—Code for the reaction

Both the values could be different or same.

Table 2-2 Product Indication—Field Description

Field/Control Name

Description

Reported Indication

By default, the value of this field is populated with the Product Indication from the Product Configuration, if set up. If not, you can enter a term into the Reported Indication field.

Note: Argus Safety automatically encodes this information. You can also click Encode to open the coding dictionary dialog box.

Coded Indication

This field is populated with the encoded term when you enter data in the reported indication field and tabs out.

Encode (Indication)

Opens the MedDRA Browser with the term already populated from the Coded Indication field.

To view the complete MEDDRA hierarchy for the encoded term, click the Encoding Status icon.

Add

Adds a new Indication row.

Only two indications are visible at a time

Delete

Click this button to delete the selected Indication row.

2.4.3.3 Enter Quality Control information

To enter quality control information, click Quality Control.

When you enter information in this section, an action item is automatically created in that case with text Case Product <<Product Name>> sent for QC requires follow up. This action item is assigned to the you.

If you do not intend to create any action item, then it add a date in the Product > Quality Control > QC Result Date field.

The Action item code when QC info is entered common profile switch is used to set the action item code as selected in this switch. If this switch is left blank, then no action item code is set.

Field

Description

Quality Control Safety Date

Enter the Quality Control department reference number for the analysis.

Quality Control Cross Reference

Enter the Quality Control department reference number for the analysis.

# CID Number

Control Identification Number

PCID Number

Product Control Identification Number

Lot Number

If the Lot Number entered is incorrect, a Lot Number Lookup dialog box is displayed, that allows you to select from the existing lot numbers.

Quality Control Result Date

Enter the date the result of the analysis was received by the Quality Control department.

Quality Control Result

Enter a text explanation as necessary. Use the zoom icon to open the zoom notes and view or edit the text.

2.4.3.4 Enter dosage regimens

Field/Control Name

Description

Stop Date/Time

Enter the stop date and time of the dosage. Entry of time information is optional, and you can enter partial dates.
Note: If no Stop Date is entered, Onset from Last Dose is calculated from the Event Onset Date and the most recent Stop Date or the most recent Start Date.

Ongoing

Select this checkbox if the drug treatment is ongoing.
The Stop Date, Duration of Regimen, and Last Dose fields are removed if this checkbox is checked.

Outside Therapeutic Range

Check this checkbox if the drug has not been used in accordance with the label or has been used for outside the Therapeutic Range.
Contact your administrator for further company-specific information on the use of this field.

Duration of Regimen

This value is calculated based on regimen start and stop dates (if full dates are entered for the start and stop dates). If the value is entered manually, the duration units (for example: minutes, hours, days, months, or years) must also be entered along with the actual duration.
Note: Contact your administrator to set the duration to be inclusive or exclusive. In Inclusive mode, the starting day counts in the calculation of the duration; in Exclusive mode, it does not.

Dose Description

This value is entered by using the values from Dose, Dose Units, and Frequency. If necessary, you can change this value.
If Dose, Units, or Frequency information is changed, this value will be recalculated.

Daily Dosage

This value is calculated based on the dose and frequency. It can be manually overwritten. If either the dose or the frequency fields are blank, this field is not calculated automatically.

Regimen Dosage

This value is calculated based on the daily dose, duration, and frequency. This total can be overridden. If the daily dose is blank or the frequency fields are 0, this field is not calculated automatically.

Regimen Dosage Unit

This value is derived based on the Daily Dose Units.

Accidental Exposure

Select the type of Accidental Exposure from the list. A non-modifiable list of items is provided for this list.

Pack Units

Select the package presentation information of the product.
Contact your administrator to adjust this list.

(New) Tab

Click this tab to create a new dosage regimen entry.

2.4.3.5 Enter product details

Field/Control Name

Description

First Dose

The earliest regimen start date.

Last Dose

The latest regimen stop date.

Duration of Administration

Calculated automatically if full dates are available for the first and last doses.

Total Dosage

Calculated based on daily dose and duration.

Time Between First Dose/Primary Event

The time from the first dose to primary event onset.

Time between Last Dose/Primary Event

The time from the last dose to primary event onset.

Total Dose to Primary Event

The cumulative dose to the time of the event.

Action Taken

Select a term.
If you select Dose Increased or No change, the dechallenge and rechallenge fields are disabled.

Contact your administrator to adjust this list.

Dechallenge Results

Indicates the drug stopped for the purpose of determining if it was the drug that caused the adverse event.

Date

Enter the date the dechallenge was carried out.

Gestation Period at Exposure

Gestation Period at Exposure is automatically calculated for all Products in the case by using the formula: Date of First Dose of the respective Product – LMP Date. It is calculated only if full dates available for both fields.

Taken Previously / Tolerated

Select a response from the list.

Rechallenge Results

Make a selection based on whether the drug was taken again.
If Pos or Neg or UNK is selected for the Rechallenge field, the following fields are enabled:

- Rechallenge Start Date/Time

- Rechallenge Stop Date/Time

- Rechallenge Outcome

Start Date/Time

Enter the date and/or time when the rechallenge was started.

Stop Date/Time

Enter the date and/or time when the rechallenge was stopped.

Specialized Product Category

Select specialized FDA product categories such as combination products, compounded and repackaged products used in eVAERS reports.

Abuse

Check if the patient abused the product (For example: Painkillers taken without pain).

Batch and lot tested and found within specifications

Check if the batch and lot was found to be within specifications, after being tested.

Batch and lot tested and found not within specifications

Check if the batch and lot was not found to be within specifications, after being tested.

Tampering

Check if the product appeared to have been tampered with before it was used.

2.4.3.6 Enter study drug information

You can enter a Study Drug for a Non-Configured Study entered in a case and mark a current product as a study drug.

To mark a product as a study drug:

1. Right-click any suspect product in the case.

2. To mark the current product as a study drug, select Make Study Drug.

When you mark a product as a study product, then the following changes are observed in the Product tab:

- The drug type is disabled to make the product a Concomitant or Treatment/Other option.

- Study Drug is a read-only field that contains the product name selected by you.

2.4.4 Enter device information

2.4.4.1 Enter product information

Field/Control Name

Description

M/W Info

The MW Info dialog box allows you to enter the following device information:

- Is this a single-use device that was reprocessed and reused on a patient?—Indicate whether the device was labeled for single use. If the question is not relevant to the device being reported (for example, an X-ray machine), leave the select box cleared.

- Reprocessor Name—Enter information for Address 1, Address 2, City, State, Country, Postal Code, Fax, and Email Address.

- Select if the device was an Adverse Event or a Product Problem.

- Type of Follow-up Report—Select a checkbox that describes the nature of the follow-up (supplemental) report:
Correction—Changes to previously submitted information.

Additional information—Information concerning the event that was not provided in the initial report because it was not known/available when the report was originally submitted.

Response to FDA request—Additional information requested by FDA concerning the device/event.

Device Evaluation—Evaluation/analysis of the device.

- Enter information for Address 1, Address 2, City, State, Country, Postal Code, Fax, and Email Address.

- Device Evaluated by Mfr—Select the Not returned to mfr. checkbox if an evaluation could not be made because the device was not returned to or made available to the manufacturer.
Select Yes if an evaluation was made for the suspect medical device. You can attach a summary of the evaluation and select Yes, Summary Attached.

If an evaluation of a returned suspect or related medical device was not conducted, check the No checkbox and attach an explanation or provide an appropriate code from the coding manual (Part II, Subpart A).

- Reason for Non-Evaluation—Enter the reason for the device not being evaluated by the manufacturer.

- Other Reason for Non-Evaluation

- If remedial action initiated, check type—Select the applicable actions. If other, specify the type of action in the space provided (for further reference, see 21 U.S.C. 360h and 21 CFR part 803).

- Usage of Device—Make a selection to indicate whether the use of the suspect medical device was the initial use, reuse, or unknown.

- USC 360i(f) correction/removal reporting number—Enter the number that the FDA assigned to the corrective action. If the FDA has not yet assigned a number, the internal number assigned to the action by the company is used.

- Additional manufacturer narrative—Check the checkbox (if applicable) and enter any additional information, evaluation, or clarification of data presented in previous sections.

- Corrected Data—Check if the data is corrected.

EU/CA Device

The EU/CA Device dialog box allows you to enter the device information. Fields are marked by either an EU flag or a Canadian flag to indicate which entity is mapped to the field.

- Associated Devices—Enter the associated devices with the device.

- Associated Accessories—Enter the associated accessories with the device.

- Firmware version—Enter the firmware version.

- Periodic Summary Report (PSR) ID—Enter the PSR ID, if any.

- Identification of Notified Body involved in Conformity Assessment—Enter identification number of the Notified Body involved in the conformity assessment procedure (if any) and the date(s) of the attestation(s).

- Remedial Action by HC Facility: Enter the remedial action taken by the Healthcare facility.

- Update to Initial Report (Follow-up Report): Check if the Follow-up report must be updated to an Initial report.

- Availability of Device: Select whether the device was Destroyed, Returned to Manufacturer/Importer, or Neither.

- Current location of device: Enter the present location of the device that was involved in the incident.

- Other—This field is enabled when you select Other in the Current location of the device drop-down.

- Final Report—Check if this is the final report.

- MIR Report Type—Select the MIR report type as Follow-up Report, Final (Reportable), or Final (Not Reportable).

- Rationale for Not Reportable—Enter the reason why the considered report is not reportable. This field is enabled when the MIR Report Type is selected as Final (Not Reportable).

- Where was the device purchased: Enter the establishment where the device was purchased.

- Root cause confirmed—Select an option.

- Risk assessment—Specify if the risk assessment has been reviewed and is adequate. Select an option as Reviewed and Adequate, Reviewed and Not Adequate, or Not Reviewed.

- Rationale—Enter the reason for why a review is not required. This field is enabled when the Risk assessment is selected as Not Reviewed.

- Results of Assessment—Enter the results of assessment.

- Marketed Device Variant/Subset: Enter the value for device variant or subset.
The valid values are:

0 – Model

1 – Software

2 – Other Variant

3 – Lot/Batch

Similar Incidents

Similar incidents occurring with the same device type or variant of a given manufacturer with the same investigation finding (IMDRF investigation finding; Annex C) and the same medical device problem (IMDRF medical device problem; Annex A) have to be reported to National Competent Authorities (NCA) and European Commission (EC).
Identification and computation of the count of similar incidents is done outside the application. The application captures the fields for the provided results.

- Similar Incident Device Category—Select the device or device variant used for identification of the similar incidents.

- Details of the Device Category—Enter the details of the selected device or device variant.

- Criteria for Number of Devices on the Market—Select the criteria used for the number of devices in the market.

- Other—This field is enabled only when you select Other in the Criteria for Number of Devices on the Market field. Describe the criteria.

- Similar Incident Analysis Based on—Select the details based on the similar incident analysis.

- Rationale—This field is enabled only when you select Other IMDRF Annex or Other Inhouse Codes in the Similar Incident Analysis Based on drop-down.

- Inhouse Medical Device Problem Code and Term—Enter the most relevant in-house medical device problem code and term used for identification of similar incidents. This field is enabled only when you select Inhouse Codes in the Similar Incident Analysis Based on drop-down.

- Inhouse Evaluation Result/Findings Code and Term—Enter the most relevant in-house root cause evaluation code and term used for identification of similar incidents. This field is enabled only when you select Inhouse Codes in the Similar Incident Analysis Based on drop-down.

- Start Date—Enter the start date for the period for which the analysis of similar incidents is performed.

- End Date—Enter the end date for the period for which the analysis of similar incidents is performed.

- No of Similar Incidents in Incident Country—Enter the number of similar incidents occurred in the incident country.

- No of devices in Incident Country—Enter the number of devices in the incident country.

- No of Similar Incidents in EEA+CH+TR—Enter the number of similar incidents that occurred in European Economic Area, (EEA), Switzerland (CH), or Turkey (TR).

- No of devices in EEA+CH+TR—Enter the number of devices in European Economic Area, (EEA), Switzerland (CH), or Turkey (TR).

- No of Similar Incidents in World—Enter the number of similar incidents that occurred in world.

- No of devices in World—Enter the number of devices in the world.

- Comments—Enter the comments for identification of similar incidents.

2.4.4.2 Enter Quality Control information

See Enter Quality Control information.

2.4.4.3 Enter product indications

See Enter product indications.

2.4.4.4 Select product delivered by device

Field/Control Name

Description

Type of Drug

Select the type of drug from the drop-down list.

Other Mfg Product

Displays the Other Manufacturing Product.

Add

Adds another row.

Delete

Deletes the highlighted row.

2.4.4.5 Enter device component information

Field/Control Name

Description

Component Name

The device component name used in the product.

IMDRF Code

Select the IMDRF code for the medical device component via lookup.

Component Term ID

The device component term ID of the device component used in the product.

Version

The Date or Version of the device component term ID of the device component used in the product.

Batch Lot #

The batch lot number of the device component name used in the product.

Add

Adds another row.

Delete

Deletes the highlighted row.

2.4.4.6 Device information—field descriptions

- You can enter up to 10,000 characters in the Additional Manufacturer Narrative field.

- The device evaluation codes have been updated to reflect FDA standards. Go to the following link for more information: http://www.fda.gov

- The evaluation method is available is the following site: http://www.fda.gov

- The evaluation results are available at the following site: http://www.fda.gov

Field/Control Name

Description

Product Information

Catalog #

Under Catalog#, enter the exact catalog number as it appears in the manufacturer's catalog, device labeling, or accompanying packaging.

Implant facility

Enter the healthcare facility where the device was implanted.

Explant facility

Enter the healthcare facility where the device was explanted.

UDI System

The UDI System captures the unique identification type of the given device.
The valid values are:

GS1 – Global Standards 1

HIBCC - Health Industry Business Communications Council

ICCBBA - The International Council for Commonality in Blood Banking Automation

Unique Identifier (UDI) #

Under Unique Identifier (UDI) #, enter any other applicable identification number (for example: component number, product number, part number, bar-coded product ID).
Data is entered in such a way to handle the UDI Device identifier and UDI Production Identifier fields.

UDI -DI

Enter the UDI device identifier.

UDI-PI

Enter the UDI-Product identifier.

Unit of Use UDI-DI

Enter the Unit of Use UDI-DI.

Operator of Device

Select the type of person operating or using the suspect medical device on the patient at the time of the event such as Health Care Professional, Patient, Paramedic and so on.

If Other

If the operator of the device is other, enter the operator of the device.

Malfunction Type

Make a selection to indicate the type of reportable event. For an event associated with a malfunction, the FDA refers to applicable sections in 21 CFR Part 803 reporting guidelines.

Device Available for Evaluation

Indicate whether the device is available for evaluation. Also, indicate whether the device was returned to the manufacturer and if so, the date of the return.

CE Marked

Select whether the device is CE Marked or not. This information is preloaded from License information for a case booked manually, through E2B or LAM, and can be modified as needed.

Similar Device

Check this check box when you report similar devices to FDA. You must report similar devices when a device causes reportable malfunction and it is likely that malfunction can occur in similar devices.
Similar devices are identified in a case when this check box is checked along with the Drug not administered check box being checked and Product Type set to Treatment/Other.

Malfunction Information

-

Reported Malfunction

Enter the malfunction as entered by the reporter.

Determined Malfunction

Enter the malfunction as determined by the company.

Listedness

Enter the listedness of malfunction in respect of the device.

Reportable

Select the reportability of the malfunction.

Patient Problem and Device Problem Information

This section captures the problem details for a patient or device. It contains the following fields:
FDA Code (for patient problem)

Patient Problem

FDA Code (for device problem)

IMDRF Code

Device Problem Term

Use the Patient Problem and Medical Device Problem lookups to search the problem information.

Evaluation/Investigation Code Information

To enter the applicable codes from the categories listed, click Select. It contains the following fields:
FDA Code

IMDRF Code

Method/Type Term

Result/Findings Term

Conclusion Term

Follow the instructions in the dialog box to enter the evaluation codes. Conclusion codes must be entered even if the device was not evaluated.

Health Impact Information

This section captures the health related information. It contains the following fields:
IMDRF Code

Health Impact Term

Incident Information

This section captures the incident details. It contains the following fields and supports multi-record entry. The Event Type Level codes are cascading, that is, Event Level 2 depends on 1.
Event Type Level 1

Event Type Level 2

Manufacturer Event Type Level 3

Event Type Level 3 Description

Manufacturers Final Investigation Results

This section captures the investigation details. It contains the following fields and supports multi-record entry. The Evaluation Type Level codes are cascading, that is, Evaluation Level 2 depends on 1.
Evaluation Type Level 1

Evaluation Type Level 2

Manufacturer Evaluation Type Level 3

Manufacturer Evaluation Type Level 3 Description

EU/CA device dialog box—field descriptions

Field/Control Name

Field Length

Field Type

NCA Reference Number

100 characters

Alphanumeric

Identify to what other NCA's this report was also sent

2000 characters

Alphanumeric

Number of Patients Involved

3 characters

Numeric

Number of Devices

3 characters

Numeric

User facility reference number

20 characters

Alphanumeric

Remedial Action by HC Facility

1000 characters

Alphanumeric

Usage of Medical Device

N/A

Checkbox

Other

15 characters

Alphanumeric

Update to Initial Report (Follow-up Report)

N/A

Checkbox

Final Report

N/A

Checkbox

When you select the EU/CA Device option, the fields on the Case form are printed. A track of the fields and any updates are maintained in the audit log.

2.4.5 Enter vaccine information

2.4.5.1 Enter product details

This section is the same for the Product Details section under all the tabs - in the Drugs tab, Device tab, and the Vaccine tab.

See Enter product details.

2.4.5.2 Enter prior adverse events information

1. Enter the relevant vaccination information items in the form.

2. Click OK.

2.4.5.3 Enter product information

Field/Control Name

Description

Include in VAERS Block

Select the VAERS Form block that this vaccine needs to be printed in.

- Suspect

- Concomitant

- Treatment/Other

Make a selection for the product you are entering. The drug types indicate the involvement of the product with the adverse event(s) reported for the case.

- Suspect indicates that the product may have caused the adverse event(s).

- Concomitant indicates drugs that are taken with the suspect drug.

- Treatment/Other is the drug taken to treat the adverse event.

Generic Name

Enter the generic name of the drug in a manner similar to the Product Name.
if the study is blinded, the Generic Name is replaced with the Study Name of the product.

This name is entered based on the selected company product.

Formulation

Select the formulation of the product. Contact your administrator to adjust this list.
Note: This field is entered based on the product.

Drug Authorization Country

Displays the licensed country for the selected company product.

Concentration

After a drug and formulation have been entered, select the concentration from the list, or enter the concentration. If this information is changed manually, the product is marked as a non-company product.
Note: This field is entered based on the selected product. The concentration cannot be modified for a Study drug.

Units

Select a concentration unit.
Contact your administrator to adjust this list.

Interaction?

Indicates whether the case involves a drug interaction.

Contraindicated?

Indicates whether the drug was administered contrary to its indication. Make the appropriate selection to indicate whether the drug was contraindicated in this case.

2.4.5.4 Complete vaccine administration form

Field/Control Name

Description

For VAERS Form-1 Use Only

Resp. Physician

Enter the name of the physician responsible for the patient.

County

Enter the county where the patient was vaccinated.

State

Enter the state where the patient was vaccinated.

CDC/FDA VAERS #

Enter the verification number.

Purchased With

Select an item from the list to describe how the vaccine was purchased.

Vaccine Facility Information

Facility Name

Enter the name of the facility where the vaccine was administered.

Country

Enter the country of the facility where the responsible physician works.

Facility Type

Enter the facility type where the patient was vaccinated.

Facility Military Flag

Indicates whether or not the vaccination facility was a Military facility.

2.4.5.5 Enter vaccine history

Field/Control Name

Description

Route of Admin

Enter the route of administration or a short code for the route of administration.
Contact your administrator to adjust this list.

Anatomical Location

Select the anatomical location of the vaccination.
Contact your administrator to adjust this list.

Block 14

If this box is checked, this Vaccine History will be printed in the VAERS Form Block 14.

Add

Adds a new Indication row.
Note: Only two indications are visible at a time.

Delete

Click this button to delete the selected Indication row.

2.5 Enter event information

You can enter or view details for adverse events for a case using this tab. It has the following sub-tabs:

- Events tab

- Event Assessment tab

- Product-Event Details tab

2.5.1 Events tab—field descriptions

Field

Calculation

Total Dosage

The sum of all Total Regimen Dosages.

First Dose to Onset

The system calculates this value based on the First Dose Stop date and the event onset date if present.
If any regimen start date is null, the system sets the First Dose to Onset to null.

The system uses only complete date entries for the regimen start and stop date/time fields to calculate First Dose to Onset.

The user can overwrite this field.

Last Dose to Onset

The system calculates this value based on the last dose stop date and the event onset date if present.
If the regimen start date is null, the system sets the Last Dose to Onset is to null.

The system uses only complete date entries for regimen start and stop date/time fields to calculate the Last Dose to Onset.

The user can overwrite this field.

- You can change the listedness for a drug at the individual level.

- The field labels for the Event Assessment tab can be updated and configured on the Argus Console.

- If the Death Seriousness criteria on the Event tab are unchecked, the event outcome reverts to empty and is not set to fatal.

- The MedDRA LLT term selection behavior across the Case Form is based on the profile switch value configured in the Allow User to Add Non-Current MedDRA Terms for and On change of LLT Term Sync English and Japan LLTs, irrespective of the currency.

- The system populates the To be coded value on the MedDRA pop-up window when you check the green checkbox for the MedDRA hierarchy. This applies to the areas where the MedDRA dialog box appears.

- The Event to Exclude from Report field enables you to identify information to not include in a PMDA Expedited report.

- When this checkbox is checked, enter a justification for this action in the Reason to Exclude from the Report dialog box.
The system places a symbol to the right of the field.

- The system does not retrieve events that are excluded from a report as part of CSPSR (Clinical Study Periodic Safety Report) unless it has been configured to include them.

When you click the Recalculate button, the system does not recalculate listedness where the Event Assessment Listedness already has a case justification (generated automatically or manually overwritten).

2.5.2 Enter event information

The Event information tab lets you encode adverse events, record criteria for event seriousness, and display results of automated assessments that determine whether events are listed in data sheets. It also lists the licenses for the data sheets.

2.5.2.1 Event information—field descriptions

Field/Control Name

Description

Relationships

Click the Relationships button to view the Diagnosis-Event Relationships dialog box. This allows you to group symptoms and signs with diagnoses. This requires at least two events and a diagnosis.

Description as Reported

Enter the verbatim term used by the reporter, or patient, to describe the adverse event. As you type, the term is copied under Description to be Coded. Verbatim English translations of foreign languages may also be entered here.

Term Highlighted by Reporter

Indicate whether the primary source reporting the event considered it a major concern. If the information was not explicitly provided, the term is not considered a highlighted term. The seriousness of the reaction/event must be based on the ICH E2A criteria.
Selecting Yes does not mark this case as Serious.

Description to be Coded

You can modify the verbatim term in this field. For example, the original term can be split, or enhanced with an anatomical location. Contact your system administrator to prevent manual encoding of the description. If automatic encoding is enabled, the term can be auto-encoded to the included term level.

Onset Date/Time

Enter the date/time when the event started. Enter a partial date if the full date is not available.

Onset from Last Dose

This field is calculated from the event onset date and most recent stop date listed in the dosage regimen details of the suspect drug(s). You can also enter or modify the field manually. This field is removed if the dosage regimen is ongoing.

Duration

This field is calculated from the event start and stop dates. You can also enter or modify the duration manually.

Onset Latency

This field is calculated from the earliest first dose date of the suspect drug(s) to onset date. You can also enter or modify the duration manually.
Onset Latency = Onset Date - First Dose.

Receipt Date

Enter the date on which information about this event was received by your company. In Flexible Aggregate Reporting, this field is used to filter the events that fall out of the reporting period.

Patient Has Prior History?

Indicate whether the patient has had a prior history or has suffered from the same event in the past.

Intensity

Select the category of severity of the event. Contact your system administrator to adjust this list.

Frequency

Select the frequency of the event from the list. Contact your system administrator to adjust this list.

Outcome of Event

Select the outcome of the event. Contact your system administrator to adjust this list. If Fatal is selected, Death is selected in the list of seriousness criteria.
If the Death checkbox is subsequently cleared, the outcome still remains fatal.

2.5.2.2 Review a diagnosis-event relationship

You can group events in a case, and/or associate them with particular diagnoses. Your company may determine these or they may be reported to it. This helps in interpreting and reviewing individual case reports. You can also enable the reporting of diagnoses only while retaining database records of individual event terms.

Click the Relationships button in the Event Information section to open the Diagnosis-Event relationship dialog box.

The case must contain at least two events and, at least, one diagnosis. The events related to a diagnosis are listed on top in this dialog box and the symptoms are indented to the diagnoses. You can group events together and associate them with individual diagnoses.

2.5.2.3 Associate a symptom with the diagnosis

Click the up or down arrows to associate a selected symptom with a diagnosis. In Argus Safety, select the symptom and click Move Up or Move Down.

For example:

Defining a diagnosis-event relationship can clarify an adverse event report. Suppose an initial case report describes a patient suffering from Somnolence, Sore Throat, and Fever.

AE # Diagnosis AE Term (Associated AEs)

1 Somnolence

2 Sore Throat

3 Fever

For reports on all events, they would appear on a CIOMS-I form as:

- Somnolence [SEDATION]

- Sore Throat [SORE THROAT NOS]

- Fever [PYREXIA]

Suppose a Follow-up report then supplies information that the patient also had neutropenia, and had been diagnosed as suffering from agranulocytosis (the cause of the sore throat and fever). The somnolence was considered to be coincidental, and unrelated to any other adverse events.

Neutropenia and agranulocytosis would be entered into the system, and a diagnosis-event relationship established as follows:

AE #

Diagnosis AE Term (Associated AEs)

1

Yes agranulocytosis

2

(sore throat)

3

(fever)

4

(neutropenia)

5

Somnolence

These events would appear on a CIOMS I form as:

- AGRANULOCYTOSIS

- [AGRANULOCYTOSIS] [SORE THROAT],

- [PYREXIA NOS], [NEUTROPENIA]

- Somnolence [SEDATION]

This immediately provides a clear clinical picture of the case.

2.5.2.4 Auto-populate event information

The MedDRA application searches the term dictionary for a match at the Lower level or at the Synonym level. If a match is found, the following fields are automatically populated: Term code, Preferred Term, Included Term, High Level Term, Group Term and Body System/SOC.

2.5.2.5 Configure regulatory reporting rules

The regulatory reporting rules are mainly configured to look at Seriousness, Listedness, Causality, and Outcome. Out of these, Listedness and Causality can be captured and controlled (using the event assessment section) down to an individual license basis.

This granularity allows individual license holders to override the normal listedness and causality assessment to control the need for submissions to their local regulatory authority. Each affiliate could either suppress the need for a report by demoting the criteria or add the requirement for a report by promoting the listedness or causality.

This serves to promote the global reporting automation while maintaining the level of individual local affiliate control that is often needed.

To obtain an assessment of the adverse event, the product must be in the company's suspect product and the event must be encoded.

2.5.3 Enter event coding information

The Event Coding section enables you to enter information about the event.

Field/Control Name

Description

System Organ Class (SOC) (Code)

Displays the body system or System Organ Class. This item is automatically entered from the event dictionary used and cannot be edited.

High Level Term (Code)

Displays the high-level group term when using the MedDRA coding dictionary. This field is not shown when coding with WHO-ART and cannot be edited.

High Level Term (Code)

Displays the High Level Term when the MedDRA coding dictionary is used. This item is not displayed when event encoding is done using the WHO-ART dictionary and cannot be edited.

Preferred Term (Code)

Displays the preferred term. This item is automatically entered from the event dictionary used and cannot be edited.

Included Term (Code)

Displays the lower level term code. This item is entered from the event dictionary used and cannot be edited.

IMDRF Code

Enter the IMDRF code for Clinical Sign via lookup.

2.5.4 Enter seriousness criteria

Field/Control Name

Description

Death

Displays the Death Details dialog box
Note: If you un-check the Death option in the Seriousness Criteria, you are required to confirm the deletion of the death details.

Hospitalized

Displays the Event Hospitalization dialog box.

Other

Check this checkbox to enter explanatory text. You must mandatorily enter text, specifying the Other Seriousness Criteria.

2.5.4.1 Enter death details

1. Check the Death checkbox under Seriousness Criteria.
The form for Event Death Details appears.

2. Enter information for the items in the form.

3. Click OK to save the entered Death Details.

Note:
When Seriousness criteria Death is unchecked, the system displays a message Do you wish to delete the Death Details?. On confirming, the Death date (NF or date) and Autopsy details are cleared.

2.5.4.2 Enter hospitalization details

1. Check the Hospitalized checkbox under Seriousness Criteria.
The form for Hospitalization Details appears.

2. Enter information for the items in the form.

3. Click OK to save the entered Hospitalization Details.

2.5.4.3 Select nature of event

The Nature of Event section enables you to identify the nature of the event from the drop-down list. You can add a maximum of 50 such Nature of Event rows.

2.5.4.4 Enter event notes

The Details section enables you to enter notes related to the event. If Reported Causality is entered when the case is booked-in, the system transfers it to this field.

2.5.5 Enter event assessment information

The Event Assessment tab enables you to capture causality and listedness information for a case. All encoded events in the case are compared with the listed events for company products (agents) associated with the case.

2.5.5.1 Event assessment tab—user actions

User Action

Result

Click Datasheet column's icon

The system does the following:

- Displays the license view

- Displays the datasheet view

- Displays the License column

- Enables the icon for the License column

Click Product Name link

Displays the name for the selected product.

Click Event Description link

Displays the Event Information for the selected event.

Click Datasheet Description link

Displays the active on date, revision number, and first 1000 terms in the datasheet.
Click Print to view all the terms and click Export to export all the labeled terms to an Excel file in a single column with column header as Labeled Terms.

Event assessment—field descriptions

Field/Control Name

Description

Recalculate

Refreshes the Event Assessment section with the newly entered data if new suspect products or events are entered, or the Event Relationship is modified.

Product

Populated when events are entered in the Products tab and appears as:

- First Line - Product Name

- Second Line - Generic Name

Causality as Reported/Source/ Method/ Result

Provides the source of causality as reported such as Investigator, Healthcare Professional, and so on.
Provides the method used for causality determination.

Provides the result of the causality assessment.

Causality as Determined/Source/ Method/ Result

Provides the source of causality as determined such as Sponsor, MAH, and so on.
Provides the method used for causality determination.

Provides the result of the causality assessment.

Other Causality /Source/ Method/ Result

Provides the source of causality from any additional source such as NCA.
Provides the method used for causality determination.

Provides the result of the causality assessment.

Event

Populated when events are encoded and appears as:

- First Line - Event PT (Verbatim)

- Second Line - LLT

D/S

Displays the Diagnosis/Symptom details by D or S.

Seriousness Severity Duration

Displays the seriousness, severity, and the duration of the event.

Listedness

Indicates whether the system found the event on the datasheet for this product.

2.5.5.2 Filter event assessment details

Only the assessment rows that match the selected criteria appear in the filtering results.

Field/Control Name

Description

Product

The Product filter drop-down list contains all products listed in the event assessment. You can filter on all the products which are present in the Event Assessment dialog box.

Event PT(Description)/LLT

Contains a drop-down list of values of distinct Event PT. You can filter on all the products which are present in the Event Assessment dialog box.

D/S

Contains a drop-down list of values of D for Diagnosis or S for Symptoms.

Datasheet

Contains a drop-down list of values of distinct Datasheets.

Revision #

Displays the revision number of the Datasheet.

Active on date

Displays the date on which Datasheet was made active.

2.5.5.3 Enter product-event details

The Product-Event Details tab enables you to capture causality information for a case.

Field/Control Name

Description

Event

Populated when events are encoded and appears as:

- First Line - Event PT (Verbatim)

- Second Line - LLT

Onset from First Dose

This date is defined as the earliest regimen start date to Onset and is completed automatically. The date calculation is based on the Case Form Calculation for Inclusive or Exclusive.

Onset from Last Dose

This date is defined as the latest regimen stop date to Onset and is completed automatically. The date calculation is based on the Case Form Calculation for Inclusive or Exclusive.

Total Dose to Event

This value is calculated based on daily dose and duration.

2.6 Add attachments to your case

The Additional Information tab lets you attach notes and other items to a case. For example, you could attach a fax message that came in as part of the case and needs to be scanned and attached or an electronic file received by email. It also lets you set up cross-references to other cases such as links between cases referring to mothers and children. The total number of attachments and references attached to a case appears in the header.

- When you click the hyperlink and a reference case is present, the system opens a case number irrespective of the selected reference type when you clicked the hyperlink.

- If no sites are defined for the attachments classification, the system permits all users to view the attachments on the Additional Information tab.

- The system permits Workflow Enterprise to view all attachments across all sites.

- You can send different Case Form attachments to different agencies, based on the Attachment classification specified to the Receiving Agency in the Reporting Destination Codelist in the Argus Console. For more information, refer to the Argus Safety Administrator's Guide.

- After the records in Notes and Attachments are sorted, if the following options are invoked without closing the case, the sort order is respected in these modules:

- Case Form Print

- Medical Review

- Copied Case

2.6.1 Enter additional information for the attachments

Field/Control Name

Description

Notes and Attachments

Notes and Attachments

Lets you sort column headers to sort the records based on the fields in the Notes and Attachment section.

Classification

Select a classification that describes the attachment. Contact your system administrator to adjust this list.
Refer to the Oracle Argus Interchange User's Guide for details about Attachment Classification usage in sending attachments in electronic reports.

Incl. Reg. Sub

Check this checkbox to merge PDF attachments within the Case Form. The Incl. Reg. checkbox identifies the attachments to be included as an appendix to Expedited reports. On checking this checkbox, the Expedited reports - CIOMS I, CIOMS I (Local), US FDA MedWatch 3500 Drug and 3500 A Device print an appendix page before each attachment. This is added to the case, and marked as Inc. Reg. Sub checked.
The checkbox is available only if a PDF is selected as an attachment.

Literature Reference

Select the Literature that is related to the attachment. Attachments that have Literature reference are transmitted as inline attachments for the data element C.4.r.2 in the E2B(R3) report.

Attach File

Inserts a file attachment into the case. Maximum file size is 4 GB.

Attach Documentum Link

This option is visible only if Documentum is available.
Click Searching for Documentum to search for and attach Documentum.

References Type

Select a reference type from the list, for example, a parent-child link. Contact your system administrator to adjust this list.

ID #

Enter the case number of the case that is to be referenced.
Click Select to search for the case that is to be referenced. You can also use this field to record the reference number for external cases.

Select

Opens the Case Selection dialog box for the selected ID.

2.6.2 Sort attachments

Field

Description

Keywords

On clicking this column header for the first time, records are sorted in the ascending order (alphabetically) of the Keywords.

Date

On clicking this column header for the first time, records are sorted in the ascending order (chronologically) of the Date.

Description

On clicking this column header for the first time, records are sorted in the ascending order (alphabetically) of the Description.

2.6.3 Search for Documentum links

1. Click the Attach Documentum Link button to open the Documentum Lookup screen.

2. Enter the desired search criteria as per Type Name, Attribute Name and Search String, and click Search.

3. Select the desired link from the row displaying the search results.

4. Click Select to select the link from the list.

2.6.4 Attach files to a case

1. In the Notes and Attachments section of the Additional Info tab, click Attach File to open the Attachment dialog box.

2. Click Browse to locate a file attachment.

3. Select the file and click OK.

2.6.5 Enter keywords

You can associate keywords with a case in the Notes and Attachments section.

To attach keywords to a case:

1. Go to the Notes and Attachments section and click Select.

2. When the system opens the Attachment Keywords dialog box, select a keyword from the Select a keyword to add to the list drop-down list.
The system displays the selected keywords in the Keywords field.

3. Click OK

2.6.6 Attach references to a case

1. Locate the References section and click Select.

2. When the system opens the Case Search Criteria dialog box, enter the search parameters and click Search.

3. When the system displays the search results in the Total Number of Rows section, select the desired search criteria from the list and click Select to view details about the selected case.

2.6.7 View and print attachments

The Attachments tab enables you to view and/or print case attachments. The system prints date/time information:

- As footers on all printouts (except letters).

- In the following format: dd-mmm-yyyy hh24: mm: ss.

To print case attachments:

1. Click the Description link to display the attachment.

2. When the system opens the letter, click Print to print it.

2.7 Review local labeling

1. Hover over the Worklist menu and select Local Labeling.

2. When the system opens the Local Labeling screen, select the appropriate information as necessary.

- Filtering by Product Family: You can filter products in the Event Assessment dialog box based on the selected product families. Click the magnifying glass icon to filter the search results by product family.

- The system displays the number of cases currently in view and automatically updates the range based on the page size specified in the Search dialog box (read-only). For example, if you select 100, the system divides the displayed rows into groups of 100 cases.

- Events assessment can show all listedness values. By default, it shows listedness only for the core datasheets and countries you have permission to access.

- Diagnosis -- The Diagnosis Filter contains a drop-down list with the following values:

- D (Diagnosis)

- S (Symptoms)

- In the Events Assessment dialog box, you can filter on either the diagnosis or the symptom.

- By default, the system displays all events with the <ALL> option.

- Datasheets

- The Datasheets drop-down list contains a list of distinct datasheets.

- Displays the revision number and the date on which Datasheet was made active.

- All the blank datasheets display as a single row of Unspecified.

- When you click the Datasheet hyperlink, the system displays the datasheet notes.

- Licenses

- The Licenses drop-down list contains a list of distinct countries for the licenses.

- All licenses not associated with a datasheet appears under Unspecified and are aligned with the datasheet view.

- When you click the Licenses hyperlink, the system displays the license references.

- The Process button triggers all the applicable rules (both global and local) for the country/license type for the licenses that are assessed through this screen.

For more information about Local Labeling, see the LAM User Guide for Worklist - Local Labeling requirements.

2.8 Enable local data entry for Japan

Argus Safety supports a concept of global lock that indicates the readiness of case data for global reporting, and a concept of local data locks that indicates the readiness of case data for local reporting having fulfilled the local data entry and assessment needs.

2.8.1 Enable local data entry

The application allows local users to open a case for entering local data without globally unlocking the case and at the same time maintain the integrity of the "global" case data.

In order to achieve this:

1. The fields in the application are categorized into global and local fields. The local fields have been identified as local to one or more countries. The local fields for only Japan are supported in this release.

2. All Argus J users are considered as Japan Local user in this release and as having access to edit the Japan local fields.

2.8.1.1 About local fields

A field is identified as a Local field to one or more countries based on a new attribute in the CMN_FIELDS table. The local fields for only Japan are supported in this release.

Customers can configure any field in the Case Form > General, Patient, Products, Events tabs, and in the Analysis > PMDA tab as a Local field for Japan through back-end updates to the CMN_FIELDS table.

The Enterprise copy configuration action will copy these updates as per existing functionality.

If a customer configures a field that could update global value as a local field, it is expected that the customers maintain the integrity of the global data by business SOPs or custom software processes.

All the fields in a case that is not a Local PRPT case are simply treated as global fields.

All Argus J users are considered as having access to edit the Japan local fields.

All Japanese text fields, including J User-Defined fields are considered as Local fields for Japan.

i. All Japanese text fields are the fields that currently has separate _J columns.

ii. All fields from PMDA tab, PMDA Device Information section.

Argus Safety allows selection of secondary LLT (stored in LLT_J or LLT_CODE_J field) or Synonym (SYN_CODE_J) encoding using MedDRA J browser that does not change the base MedDRA hierarchy of English.

The Event Assessment > Listedness field in the tab for the licenses of the local country corresponding to the local user is considered as a local field. However, this field is available for editing for the user only when the local user has listedness privilege for that local country assigned to them via the User Group > Listedness Determination - Countries access and the datasheet associated with that local country license is configured with "Global / No Local Assessment Required" checkbox as unchecked.

The Events tab > Infection and Event Exclusion checkbox are also considered as a local field for Japan.

Any field where an update to a global field can occur is NOT considered as Local field.

All numeric fields, date fields, drop-down fields which share same data value for English and Japan sides are not considered as Local fields.

However, there are exceptions to this rule where some fields that contain global values are available for update to local users and in such a scenario, it is expected that the global value should be protected by customer's business SOPs.

Case classification is such a field that can cause an update to the global value and it is available as a Local field in the application out-of-the-box.

Study section under General tab requires special handling by the application during local editing. Study Name, Study Description, Protocol Number, Clinical Compound Number and Center Name are local fields.

When the study is a configured study, all these fields are disabled for local editing except Center Name (J). Center Name (J) is available as an editable local field.

Product Information section in Products tab requires special handling by the application during local editing. J Drug Code type and the corresponding J Drug Code/OTC Drug Code/Temporary Code (i.e., DRUG_CODE_TYPE_J, DRUG_CODE_J,), J Generic Name and J Product Name fields are local fields.

Any field that is already editable after case lock will remain editable even after local lock.

An auto-narrative generation performed during Japan Local data entry (after global lock) only updates the J field value and does not update the English or any other language field value.

2.8.2 Access local case data lock functionality

This section lists the different sections where the functionality for Local Case Data Lock has been documented in the Argus Safety suite of documentation.

Refer to the following table for the list of features and the corresponding Guides where they have been documented:

Local Lock Feature

Overview

Documented in

Local Locking and Local Unlocking - Configuration

Introduction of new switches: Allow Local Locking - to allow a local user to be set up with the privilege to locally lock or unlock a case
Enable Local Unlocking - to provide a system level control permitting local users to locally unlock a case and make any corrections to the previously entered local data.

Oracle Argus Safety Administrator's Guide > 2 Access Management > Configuring Users
Oracle Argus Safety Administrator's Guide > 4 System Configuration > Configuring System Management - Common Profile Switches

Oracle Argus Safety User's Guide > Global User Management

Changes to the Case Locking Mechanism in Argus Safety - Case Form Changes

Introduction of action icon - Local Lock - to allow a user to locally lock or unlock a case

Oracle Argus Safety User's Guide > 1 Getting Started > Quick Launch Toolbar

Changes to the Case Locking Mechanism in Argus Safety - Changes to global locking, One Step Global and Local Lock

Allow Global locking and triggering of global and local reports, and allow one step global and local locking

Oracle Argus Safety User's Guide > Locking a Case

Changes to the Case Locking Mechanism in Argus Safety - Changes to Global Unlocking - Configuration

Introduction of new switches:
Allow Forced unlock (Global and Local) - to allow users to be set up with the privilege to forcibly unlock a case that been globally and/or locally locked but pending report generation

Allow Global Unlock on Pending Local Lock - to allow users to be set up with the privilege to forcibly unlock a case that is still pending a local lock

Oracle Argus Safety Administrator's Guide > 2 Access Management > Configuring Users
Oracle Argus Safety Administrator's Guide > 2 System Configuration > Configuring System Management - Common Profile Switches

Oracle Argus Safety User's Guide > Global User Management

Changes to the Case Locking mechanism in Argus Safety - Changes to global unlocking - Case Form changes

Control globally unlocking a case based on local/global reports pending generation and /or cases pending local lock

Oracle Argus Safety User's Guide > Unlocking a Case

Case Form changes - Local Reports Configuration - Local Reporting Rule and Local Reports

Configuring Local Reporting Rules and Local Reports

Oracle Argus Safety Japanese Administrator's Guide > 3 System Configuration > Configuring Local Reports - Local Reporting Rule and Local Reports

Triggering Local Reports - Changes to Report Scheduling and Generation Algorithm - Auto Scheduling

Changes to report auto-scheduling for scheduling local reports

Oracle Argus Safety User's Guide > Report Scheduling - Auto-Scheduling

Triggering Local Reports - Changes to Report Scheduling Algorithm - Manual Scheduling

Changes to report manual scheduling for scheduling local reports

Oracle Argus Safety User's Guide > Report Scheduling - Manual Scheduling

Triggering Local Reports - Changes to Report Generation Algorithm

Changes to report generation for generating local reports

Oracle Argus Safety User's Guide > Triggering Local Reports - Report Generation Algorithm

Changes to Expedited Reports and Periodic Reports on DLP

Changes to DLP while generating local expedited and periodic reports

Oracle Argus Safety Japanese User's Guide > Reports

2.8.3 Process an outlier

When a suspect product with a local license is removed on a follow-up, the case remains a Local PRPT Case (Local Potential Reportable Case) until the corresponding nullification/downgrade local reports is generated.

If a customer wants to change Local Reports configuration data after being in production with this release, it is recommended that customers ensure that cases/reports under processing be completed before changing configuration data to avoid unpredictable results. Note that if a customer changes the Local Reports configuration data mid-way where the reports are mid-way processing (e.g., scheduled), the reports will be determined as local/global based on what type it was at the time when the report was scheduled and will be completed processing that way irrespective of current configuration even if inconsistent with the configuration. Also, note that presence of local reports will determine that the case is a local case.

It is also recommended that customers ensure that cases/reports under processing be completed before up taking the Local Locking feature and (thereby) installing the local lock configuration data (refer to Activate local locking in Argus Safety). Note that if the case was mid-way processing (e.g., case was open in data entry workflow) when customer up took the Local Locking feature, a subsequent case save will determine if the case is local or global.

2.8.4 Activate local locking in Argus Safety

In order to activate the Local Locking feature in Argus Safety, the installer provides the users with an option to install the underlying metadata that enables the local lock feature in the application. A customer, who may not prefer to turn on the local locking feature due to existing business processes that already handle the local processing needs for a company, could choose not to install the metadata and thus not uptake the local lock feature in the application.

A separate database script is provided so that the user can run to turn on the Local lock feature after an upgrade or fresh install. On executing this script, it prompts the user to choose to turn on the local locking feature and uptake the Local Locking seed data.

The application assumes the default value of 1, parses the user input and installs the Local Locking seed data for each of the enterprise specified in the comma separated list.

2.8.4.1 Enter local reports configuration seed data

A new table is seeded to identify Local Reports for Japan:

- Country - The seed data is the country id for Japan (from codelist Countries) for this release.

- Reporting Destination - The script prompts the customer to provide the default value of reporting destination for PMDA.
Prompt - "Please enter Agency Name for the PMDA reporting destination as configured in the "Reporting Destination" codelist. This name will be used to identify Local Reports for all enterprises".

- Report Form - The seed data is the following Japan reports:

2.8.4.2 Enter local users seed data

The upgrade installer script prompts the user to choose if all the Argus J users will be updated to have local locking privileges.

2.8.4.3 Enter local fields seed data

Note that the CMN_FIELDS are always seeded as part of install/upgrade factory data to identify the Local Fields for Japan and will be present irrespective of if the customer chooses local locking feature or not.

In case of Multi-tenancy, the customer input value is used to set the seed values across all enterprises.

This seeding of Local users data is audit logged with the system user.

After install/upgrade, if the customer has turned on the local locking, the icons in the applicable screens start reflecting the local/global lock status of the case.

3 Process case data

3.1 Access cases

3.1.1 Search for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, enter criteria for your search in any of the following fields:

- Search For—Select a parameter from the drop-down list and provide a search value in the adjacent text field.

Tip:
You can select the Pri/Stdy/Othr/Cntr/Rptr/Pat option from the Search For drop-down to simultaneously search for a value that you specified in the field adjacent to Search For by all these parameters: Project ID, Study ID, Other ID, Center ID, Reporter ID, and Patient ID.

- Date Range—Select a parameter from the drop-down list, or enter a custom date range in the From and To fields, and click OK.

Tip:
Select the Follow-up radio button to search by follow-up dates, including significant and non-significant event dates.

- Product Family—Select a product category from the drop-down list.

3. To use a new advanced condition query set as criterion for your search, select New from the Advanced Condition drop-down list or click the AC button. See Create a single filter.

4. If necessary, check the Full Search checkbox and enter a value in the field adjacent to Search For to search for cases that contain the specified value in any word order or combination.

5. Click Search.

6. From the search results list, click a Case ID link.

3.1.2 Search for a case assigned to you

1. On the Home/Personal Argus Status page, check the Cases Assigned checkbox.

Note:
If the Personal Argus Status Page is not your default home page, go to the Dashboards menu and click Personal Argus Status.

2. From the list of cases assigned to you, click a Case ID link.
Alternately, enter the exact case ID of the case in the Case Quick Launch field, and click Open.

3.2 Process cases

3.2.1 View assigned and unassigned cases

1. Hover over the Worklist menu, and do one of the following:

- To view unassigned cases and new worklist items that were assigned but not accepted by users, click New.

- To view cases that were assigned and accepted by users, click Open.

2. On the New/Open page, enter the required information, and click Search.

3. To select a case by its number, enter a value in the Case Number field.
Alternately, choose a filter from the available filters list.

Note:
Argus Safety doesn't include open cases that are assigned to you in the search results.

3.2.2 View the case workload for one or more individuals or sites

1. Hover over the Dashboards menu, and click Case Workload.

Note:
The Case Workload option displays only if you are a Workflow Manager.

2. In the Load Balancing Dashboard section, click the + (plus sign) character next to a parameter top expand it.

- Week Forecast — Displays the number of cases that Argus Safety estimates for the selected workflow state or group in the next five days.

- Refresh — Refreshes the number of cases that appear in the Load Balancing Dashboard every number of minutes you specify.

3.2.3 View the workflow status for cases

1. Hover over the Dashboards menu, and select Worklist Group.

2. Select Workflow Status.

3. Enter search parameters in the search case fields, and click Search.

4. To view cases in a specific workflow state, click a bar graph and perform a select from the drill-down menu.

Note:
The number of cases displayed changes as cases are updated during case processing.
Argus Safety saves your preferences when you return to the Workflow Status.

5. To apply additional filters, click More Filtering and use the Ctrl + Shift keyboard keys to make multiple selections.

- Site—Displays active sites except LAM sites in the Argus Code List.

- Workflow State—Displays active workflow states except Archived or Closed in Utilities - Configuration.

Note:
If you don't apply other filters, the Default Report Configuration filter shows cases for the current month. The cases are evaluated based on their Aware Date value.

6. To go to a specific worklist screen, double-click the Bar Graph.

3.2.4 Route a case to another workflow state

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Activities tab.

5. To route the case to the next workflow state, do the following:

1. Select Route.

2. From the Case Routing dialog box, select the state to which to route the case from the Route to Next State drop-down list.

Note:
You can view states that are assigned to sites in the Workflow Configuration only if you are an Enterprise Workflow Manager.

6. To route the case to the previous workflow state, do the following:

1. Click Return.

2. Enter your password in the Case Routing dialog box.

3. Select the user or group the case will be returned to from the Route to User drop-down list.

7. Enter a routing comment in the Comments field.
Alternately, click Select and choose a pre-defined routing justification from the Select a standard justification drop-down list.

8. Click OK.

9. In the Case Routing dialog box that opens, click OK.

Note:
If a case is routed to multiple workflow states or groups, it is counted multiple times in the Week Forecast.

3.2.5 Add a follow-up event to a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. If the case is locked, unlock the case by clicking the Lock icon ( ) in the Quickstart tool bar at the top right of the Case Form.

5. From the General Information section, in the Follow-ups sub-section, click the Add button.

6. In the Case Form Operations dialog box, choose if the follow-up event is a significant one by clicking the Yes or No button.

7. Modify the system date values in the Follow-up Received and Central Received fields as required for the event.

8. To add a justification for adding the follow-up event to the case, check the Amendment checkbox.
In the Amendment/Follow-up Justification dialog box, enter a comment and click OK.

9. To add more than one follow-up event to the case, click the Add button again and redo steps 5 to 7.

3.2.6 Unblind cases to a study

1. Hover over the Utilities menu, and select End of Study.

2. In the End-of-Study-Unblinding dialog box, select a study from the End-of-Study Unblinding drop-down list.

Note:
The End-of-Study-Unblinding dialog box doesn't include cases that are globally or locally unlocked, or pending local or global report submission.

3. In the Dosage Regimens dialog box, click Select and enter the drug dosage information.

4. Click OK and then click OK again.

3.2.7 Copy a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. Hover over the Case Actions menu and click Copy.

5. On the Case Copy - Webpage page, enter the number of copies to create and click Yes.

6. On the Case Copy page, select the sections from the case to copy.
To copy the entire case, click Select All.

7. Click Copy.

Note:
Argus Safety copies any blank values from the case to the case copy.

8. In the Case Routing dialog box:

1. From the Route to Next State drop-down list, select a value to represent the workflow state for the copied case.

2. From the Route to User drop-down, select a user or user group to return the case to.

3. In the Comments field, add a justification for the copy action.
To add a standard text as justification, click Select, choose the standard text from the Routing Justification dialog box and then click OK.

4. Click OK.

9. If automatic case numbering is disabled, on the Case Form for the copied case, enter a case ID.

3.2.8 Lock or unlock a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Activities tab.

5. From the Case Lock/Close section, click Lock or Unlock.

6. In the Case Locking/Unlocking dialog box, enter your Argus Safety password in the Password field.

7. To add a justification for the case lock or unlock, enter data in the Notes field.

8. If you are unlocking a Case Form, click either button to choose the focus page for significant or non-significant follow-up events:

- Significant F/U — The Follow-up Received Date on the General tab, with the Significant checkbox checked.

- Non-significant F/U — The Follow-up Received Date on the General tab, with the Significant checkbox unchecked.

9. Click OK.

Note:
You can also lock and unlock a case by clicking the Lock icon ( ) in the Quickstart tool bar at the top right of the screen.

3.2.9 Delete a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. Hover over the Case Actions menu a second time, and click Delete.

5. In the Action Justification dialog box, enter a justification in the Please enter a justification for performing this action field.
Alternately, click Select and choose a pre-defined justification from the Select a standard justification drop-down list.

6. Enter your password in the Password field.

7. Click OK.

Note:
Once you delete a case, users can no longer access it from the Argus Safety application.

3.2.10 Undelete a case

1. Hover over the Utilities menu, and select Case Undelete.

2. On the Case Undelete page, enter search values in the fields from the Case Search Criteria section and click Search.

3. Check the checkbox for the case number to restore and click Undelete.

4. In the Action Justification dialog, enter a justification in the Please enter a justification for performing this action field.
Alternately, click Select and choose a pre-defined justification from the Select a standard justification drop-down list.

5. Click OK.

3.2.11 Formally close a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Activities tab.

5. From the Case Lock/Close section, click Close.

6. Enter your password in the Case Closure dialog box.

7. Click OK.

Note:
Formally closing a case isn't the same as closing the Case Form for the case and returning to the previous page.
To modify the details of a formally closed case, you must first re-open it by providing your password.

You don't need to unlock a locked close case before you close it.

3.2.12 Print case details for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the search results list, click a Case ID link.

4. Hover over the Case Actions menu, and click Print.

- To print the Case Form for the case:

- Select Case Form.

- From the Print Case dialog box, check the checkbox for each section to print or check the Select All checkbox.

- If you don't want the print to include product information for the case, check the Blind Study Product checkbox.

- Click Print.

- To print the Medical Summary for the case:

- Click Print Medical Summary.

- From the medical summary report, select File and then Print.

3.2.13 Print letters and attachments for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the Case Form for the case, select the Additional Information tab.

4. Click the Print Case icon ( ) at the top of the page.

5. In the Print Case dialog box, select the tab corresponding to the item type to print (Letters or Attachments).

6. Click the Description link for a letter, or the Classification link for an attachment to view the item in Adobe Acrobat.

7. Click the Print File icon at the bottom.

Note:
Letters are the only Argus Safety printouts that don't include date/time information in the footer section.

3.3 Review cases

3.3.1 View correspondence contacts for a case

1. Hover over the Worklist menu, and select Contacts.

2. On the Contacts page, enter case information in the fields as necessary.

3. From the results list, click a Case ID link for which to view correspondence contacts.

3.3.2 Generate a letter on a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Selection page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. From the Case Form for the case, click the Activities tab.

5. In the Contact Log section, click New Letter.

6. From the Custom Letter Templates dialog box, select a letter template and click OK.

7. From the Save Letter dialog box, click Yes and modify the Argus generated letter as appropriate.
Alternately, click No to save the Argus generated letter as is.

8. In the Attach Letter for Case dialog box, click Browse and navigate to the location of the saved letter.

Tip:
You can then modify the value in the Date Sent field in the Contact Log to schedule an action item for the letter.

3.3.3 Track correspondence for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. From the Case Form for the case, click the Activities tab and select Contact Log.

3.3.4 View case action items

1. On the Home/Personal Argus Status page:

- To view your pending action items, check the Action Item Entries checkbox.

- To view action items for a specific case, click a case number link and then select the Activities tab.
You can view the details in the Action Items section.

2. From the Worklist menu, select Action Items, then select Worklist, and select Action Items.

- To view details for a specific case action item, enter search criteria in the relevant fields:

- S/U/R—Select the case-level assessment values for the case that contains the action items as Serious, Unlisted, Related.

- Action Item Code—Select the case action item code.

Note:
You can modify the Description value that Argus uses for the selected action item code as required.

- Check the checkbox corresponding to the type of case action item to view:

- To view only case action items with due dates before the current date, check the Overdue Action Items checkbox.

- To view only query-type case action items, check the View Query Action Items checkbox.

3.3.5 View revisions for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the search results list, right-click a Case ID link and select Case Details.
Alternately, open the case and select Case Revisions from the Case Actions menu.

4. From the Case Details dialog box, click the plus sign (+) next to Revisions.

5. Click the Revision History text to view all the revisions for the case in the Audit Log Details dialog box.

6. Click an entry under Revision History.

Tip:
For descriptions of the icons associated with the revisions, see What are the lock states for a case?

7. From the Audit Log Details dialog box, to view details for a specific revision in read-only mode, select the revision from the revisions list.

Tip:
You can also view revisions for a case by selecting Case Revisions from the Case Actions menu.

3.3.6 View the audit log for a case

1. Hover over the Utilities menu, and select Logs.

2. Select View Audit Log.

3. Enter or select search criteria for the log in the Search Conditions section and then click Search.

4. Click the Action item icon ( ) for a case.

5. In the Audit Log Details dialog box, to view details for revisions made on the case on specific date, select the date entry at the bottom of the dialog.
Alternately, check the checkbox next to the Revisions Date column to view a listing of revisions made on the case through all the dates.

3.3.7 View the coding status of a case

1. Hover over the Worklist menu, and select Coding Status.

2. On the Coding Status page, enter case search criteria.

Note:
To filter cases by an advanced condition, click Advanced. Select the advanced condition and click OK.

3. Note the coding status icon for the case.
For a description of the icons associated with the coding status, see What does the coding status icon indicate for a case?

3.3.8 Perform a medical review of a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Selection page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. Hover over the Case Actions menu and click Medical Review.

5. In the Medical Review - Case Form dialog box, to add a narrative to the case:

- Manually fill in the Narrative text box.

Tip:
To enter the narrative in a specific language, click the icon representing the language above the text area.

- Alternatively, to fill in the Narrative text box with text from an auto narrative template, click Generate.

1. In the Custom Auto Narrative Templates dialog box, select a template from the list of available templates and click Append. To replace the selected template with a new auto generated narrative template, click Replace instead.

2. To add information in addition to the narrative, click the Case Comment icon ( ).

3. If the case has events that are encoded using the MedDRA dictionary, select either 'D' for Diagnosis or 'S' for Syndrome from the D/S field.

4. To switch to data sheet view and display the License column, click the + (plus) icon for Datasheet.
Revision number and date on which the Datasheet was made active are also displayed.

6. To view a read-only version of the case, click the Temporal View tab.

1. Filter the data categories to appear in the Event Assessment section by checking the corresponding checkboxes in the Display Options section.

2. To view details for an event listed in the Event Assessment section, click the Info icon for the event.

3. Enter information about any relevant tests performed in the Relevant Tests field in the associated section.

7. To attach notes and other items to the case, or to create cross-references to other cases, click the Action Items/Addl Info tab.

3.3.9 Perform a coding review of a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Selection page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. Hover over the Case Actions menu and click Coding Review.

5. Click Product Information and review the existing information about the case.

6. To change information about the case:

1. If the product is not a predefined company product, select a value from the Formulation list.

2. Enter a value for the indication as reported in Reported Indication.

3. Enter the indication to be coded in Coded Indication LLT.

4. To display the associated coding dictionary, click Encode.

7. Click Action Items and review the existing action items for the case.

- To add an additional action item for the case:

- Enter the date an action item was created for the case in Date Open.

- Select an action item code from the Code list.

- Select a group to be responsible for the action item from the Group/Responsibility.

- Enter the date on which the action item must be completed in Due.

- To mark an existing action item for the case as Completed, enter the completion date in Completed.

3.3.10 Perform a regulatory submission review of a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Analysis tab.

5. To view differences in narratives for the case, in the Case Analysis section, click Show Difference.

Note:
The Show Difference button is enabled only if at least one previously locked version exists for the case.

6. To create a MedWatch 3500A Drug Report, select the MedWatch Info subtab.

1. Enter the following details in block B:
- If the product caused an adverse event in a patient, in Block B, select Adverse Event.

- If a product defect or malfunction lead to the death or serious injury of a patient, select Product Problem.

- If a malfunction or problem of the product caused the death or serious injury of a patient, select both Adverse Event and Product Problem.

2. In block C, enter medication data in Suspect Medications.

3. Enter the following information in block F:
- If you selected Product Problem in block B, enter the National Drug Code in Suspect Medications (NDC#).

- Select the option corresponding to the origin of the report – User Facility or Distributor.

- If you don't want the MedWatch 3500A Drug Report to include information from block F, select Suppress Block F Printing.

- Enter the report number in full as shown in the upper-right corner of the screen in UF/Dist report number.

- Enter the details of the user facility or distributor reporting site in User facility or distributor name/address.

- Enter the details of the contact person for medical device reporting (MDR) in Contact person.

- Enter the date when the user facility's medical personnel or the distributor became aware that the device may have caused or contributed to the reported adverse event in Date aware of event.

- Click the first row and column of the FDA Patient and Device Codes section and then click Select.

Note:
You can enter up to six FDA Patient Codes in the FDA Codes dialog box. If the entered code isn't present in the FDA Codes list, Argus Safety deletes it.

- If a report was sent to the FDA, check the Report sent to FDA checkbox and enter the date.

- If a report was sent to the manufacturer, select the Report sent to mfr? checkbox and enter the date.

4. Enter the following information in block G:
- Match all report sources in Reporter Type by checking the corresponding Report Source checkboxes.

Note:
If the country of incidence isn't the US, the value 'Foreign' appears by default.
If the primary reported on the General tab is a health care professional, the value 'Health Professional' appears by default.

Alternately, select Other and enter the necessary text.

- Enter the PLA number in STN# Pre-1938 / OTC Product.

- If the product pre-dates 1938, select Pre-1938.

- If the product is an over-the-counter product, select OTC product.

7. To review information about the history and the current condition of the patient and generate the BfArM 643 form, select the BfArM Info subtab.

Note:
If available, Argus Safety uses the relevant information from the Current Medical Status Form on the Patient tab to fill in the fields on the BfArM Info tab.

1. Enter a causality or modify the existing value from the Causality drop-down list.

2. Select or modify the existing values that apply to the patient from the drop-down lists in the Check One in Each Category section.

8. To assess imputability for the suspect product, select the AFSSAPS Info subtab.

1. Check one or more checkboxes in AFSSaPS Information.

Tip:
Check the Autres checkbox to enable the corresponding field.

2. Enter a description in Future Actions.

3.4 FAQs

3.4.1 What is a case owner?

A case owner is the first user to accept a case after book-in. This user has the right to assign the case to another user.

3.4.2 Can I reassign a case to another owner?

Yes, you can reassign a case to another user if you are a Workflow Manager and the initial owner of the case.

3.4.3 When does a case become open?

Argus Safety assigns the Open state to a case when the user accepts their assignment to the case.

3.4.4 How do I create a query-type action item for a case?

Based on the advanced conditions rules for the query-type action item, Argus Safety generates an open query-type action item when you save a case or when you click the Generate Query icon on the Quick Launch toolbar for a case.

The Due Date for the query-type action item is the System Date plus the Due Date (in days) as defined in the codelist. Similarly, the Open Date is the system date on the day the Query was created for the case.

3.4.5 What happens to a query-type action item after its due date has passed?

Once the due date for a query-type action item has passed, Argus Safety:

- Closes the query-type action item, if it doesn't meet the criteria of the Advanced Conditions for the case.

- Attempts to resolve the open query-type action item in the Case Form without creating a new action item with the same name.

3.4.6 How can I view a summary of all the open cases?

To view a summary of all the open cases in PDF format, hover over the Dashboards menu and select Open Case Summary.Cases in the summary are sorted in ascending order as per the number of days each case has been open.

3.4.7 How can I view a summary of cases with open action items?

To view a summary of cases with open action items in PDF format, on your Personal Argus Status page, hover over the Dashboards menu and select Open Action Items.

3.4.8 When can I formally close a case?

You can formally close a case only if the following conditions are met:

- You have access rights to the case.

- Action items for the case are complete.

- Expedited regulatory reports for the case are submitted.

- Expected follow-up information for the case was received.

- The case isn't locked.

Closing a case is the final stage of the case workflow. After a case is closed, Argus Safety archives it.

3.4.9 What happens to a study if I unblind the cases that are associated with it?

If you unblind cases that are associated with a study that is complete and single or double blinded, Argus Safety sets the Blinding Status value of each case to Broken After Study.

3.4.10 How can I track which case revision contains significant follow-up information for the case?

Argus Safety uses the following designations for items in the Audit Log Details dialog box:

- (S) F/U — Significant follow-up information was attached to the case.

- (NS) F/U — Non-significant follow-up information was attached to the case.

Users can mark follow-up information as significant or non-significant on the General Information tab of the Case Form for the case.

Each company can use its own definition of what significant follow-up information represents.

3.4.11 How can I interpret the differences between two narratives for a case?

Argus Safety uses the following conventions to signal the differences between two narratives on the Show Difference page:

- Strikethrough red text with yellow highlight — Narrative text that was removed.

- Regular text with green highlight — Narrative text that was added.

3.4.12 What other case details can I retrieve from the Routing Comments log?

In addition to user justifications for case routing, the Routing Comments log also includes details of any lock/unlock action that a user did on the case, even if that user was a system user such as the AG Service.

Note that the log displays only one entry if a global/local lock or a global/local unlock is applied at the same time to the case.

3.4.13 Can I view the original case from a copied case?

Yes, to view the original case, open the case form, and select the Additional Information tab for the copied case. The original case appears highlighted in the References section.

3.4.14 What are the lock states for a case?

Argus Safety uses the following states for a locked case:

- Local Locked ( )— The case requires follow-up. Any user who tries to access the case will be required to either view it as read-only, or unlock of the case at the local level.

- Local Unlocked ( )— The case is available to other local users.

- Global Locked ( )— The case requires local reporting.

- Global Unlocked ( )— The case doesn't require local or global reporting.

- Global Locked and Local Locked ( )— The case is a Local PRPT case and is locked at both local and global levels for all local countries for the case.

- Global Locked and Pending Local Lock ( )— The case is a Local PRPT case and is locked at global level but pending a local lock for any local country for the case.

3.4.15 Can I apply a local lock on a case that already has a local lock for another country?

Yes. You can apply a local lock on case that already has a local lock only if:

- Enable Local Unlocking is set to 'Yes' for your tenant.

- There are no local reports pending for the case in the country for which the initial local lock was applied.

3.4.16 If I am an Argus Safety Japan user, can I enter local data, copy or modify a case that has a global lock?

Yes, you can enter local data, copy, or modify a case that has a local lock. However, you can't change the Classification value or generate local reports for the case.

3.4.17 If I am an Argus Safety Japan user, can I apply both a local and a global lock on a Local PRPT case that I entered?

Yes, you can apply both a local and a global lock on a Local PRPT case in one step if you select the Perform Local lock additionally for a Local PRPT case option in the Case Locking dialog box.

If this option isn't available, contact your Administrator to set the value for Enable Local Unlocking to 'Yes' for your tenant.

3.4.18 Can I change the outcome of a case as part of my medical review for the case?

Yes, you can change the value of the Case Outcome field based on your medical review for the case.

Argus Safety sets an initial value of the Case Outcome field based on the outcome values of events from the Events tab of the case.

Note that changing the outcome for the case doesn't change the outcome value for any of the events for the case.

3.4.19 Can I change the causality for a case during my medical review?

Yes, if values already exist in the Causality as Reported and Causality as Determined fields on the Medical Review page, you can change them during your medical review.

- Argus Safety automatically adds the text that was added to Reported Causality when the case was booked in. You can select a different value for Causality as Reported, respectively override the text in Causality as Determined if you have the necessary access rights.

- Your Administrator is responsible for maintaining the list of available causalities for a case and for defining which causalities can be reported.

3.4.20 What do the case assessment values stand for?

Argus Safety uses the following assessments values for a case:

- S — Serious

- U — Unlisted

- R — Causality

- A — Unknown

- F — Fatal

- LT — Life Threatening

- H — Hospitalized

3.4.21 Who is the MDR contact person?

The Medical Device Reporting (MDR) contact person is the designated contact for the device user facility or distributor and the person the FDA conducts MDR correspondence with. This individual may not be an employee of the facility.

3.4.22 How does Argus set the Receipt Date for a case?

Argus Safety sets the value of the Receipt Date field based on the state of the Display Initial Receipt Date always option.

- When the Display Initial Receipt Date always option is enabled, and there is follow-up information for the case, Argus Safety uses the value from the Initial Received Date field.

- When the Display Initial Receipt Date always option is disabled and follow-up information exists for the case, Argus Safety uses the value of the latest Follow-up Received Date regardless of the significance of the information.

3.4.23 How does Argus set the Aware Date for a case?

If follow-up information exists for a case, Argus Safety uses the value of the latest significant follow-up information as the Aware Date for the case.

If follow-up information doesn't exist for a case, Argus Safety uses the value of the Initial Receipt Date field as the Aware Date for the case.

3.4.24 How does Argus set the Date Received value for a case?

The Date Received value is the latest Follow-up Date value for the case.

- If there are multiple Follow-up Date values, then the Date Received value is the oldest Follow-up Date value that exists for the case.

- If there is no Follow-up Date value for the case, then the Date Received value is the initial Receipt Date value for the case.

3.4.25 Which actions can I perform on a saved letter?

You can view saved letters in the Uploaded letters folder.

You can edit a saved letter by clicking the corresponding email button in the Contact Log and then editing it in the message editor.

3.4.26 Can I edit or remove a letter after it was sent for a case?

After a letter is sent, you can no longer edit it. You can only remove it manually.

3.4.27 If I change the Date Sent value for a letter, must I also change the Due Date for the action item associated with the letter?

No. Unless the action item that is associated with the letter has already been completed, when you change the Date Sent value for the letter, Argus Safety also updates:

- The Due Date for the associated action item, to match the new Date Sent value.

- The number of days for the action item that is specified in the letter configuration.

3.4.28 Where can I view action items for letters?

You can view action items for letters for a case in the Action Items section on the Case Form for the case. You can view action items for letters across cases on the Action Items page from your personal worklist.

3.4.29 Why do only some action items for a case appear as Sent in Letter?

Action items that appear as Sent in Letter are query-type action items for the case.

3.4.30 Can I auto-generate a letter for a case?

No. For Argus Safety to auto-generate a letter after you save a case, contact your system administrator.

Based on settings, Argus Safety can:

- Auto-generate a letter after a specific number of days since an adverse event is reported for a case.

- Auto-generate a follow-up action item for you to follow up with a correspondent after the letter is sent.

Auto-generated letters are sent to the first correspondence contact by default.

3.4.31 Which actions can I do on an auto-generated letter?

You can view auto-generated letters in the Contact Log section of the Case Form for a case.

You can view or print an auto-generated letter by double clicking the letter icon in the Contact Log section and selecting the associated action from the Letter Preview dialog.

3.4.32 What does the coding status icon indicate for a case?

The coding status icon indicates the state of the term to be coded for a case.

- Red cross mark ( )—The term was coded.

- Green check mark ( )—The term was successfully coded.

- Grey hourglass ( )—Argus Safety submitted the term to Central Coding, but didn't yet receive a result.

- Red stop sign ( )—Argus Safety submitted the term to Central Coding but received an error either from Central Coding or from Argus.

3.4.33 Why does a border appear for a coding action item for a case?

A red border indicates that the respective action item was completed for the case. Oppositely, a green border indicates that the respective action item wasn't completed for the case.

3.4.34 Why is there a green dot in the Notes area of a case summary?

The green dot that appears in the Notes area is an option for the related field. You can click the dot to revert to the initial automatic value for the field, or view previous overriding notes.

3.4.35 Why do only some user names appear in bold in the Case Workload?

User names that appear in bold in the Case Workload are online users who can view the Online Help icon.

3.4.36 Why does the ( ) icon appear as the lock state icon for a case?

The ( ) icon denotes that the case is a Suspected Unexpected Serious Adverse Reaction (SUSAR) case.

3.4.37 Why do some letter icons from the Contact Log have an exclamation mark?

Letter icons that have a green exclamation mark indicate letters that were successfully sent.

Letter icons that have a red exclamation mark indicate letters that are overdue.

3.4.38 Why does an asterisk (*) symbol appear next to the username for some users in the Case Routing dialog?

The asterisk (*) symbol next to a username denotes that the user who entered the routing justification for a case has since received the Disabled status in Argus Safety.

3.5 What if

3.5.1 The Medical Review page appears empty for a Case Form

The fields on the Medical Review page are user-defined. To view them, you must first enable the desired fields from Analysis page in the Case Form. The system saves the selection as a default and uses it when you open the Medical Review page for other case.

3.5.2 The narrative text for a case contains blank spaces or placeholders

Blank spaces or placeholders can appear when the narrative text for a case is auto-generated. Argus Safety displays blank spaces for placeholders that are missing data, and actual placeholders if the placeholders are incorrect.

Contact your Administrator to amend the template for the auto-generated narrative text, or to enable auto-generated narrative text to be modified.

3.5.3 I can't change the assessed seriousness of a case

If any Seriousness Criteria was selected for any Event on the Event page for the case, Argus Safety automatically sets the value of Case Serious to 'Yes'. To override this value, contact your Administrator to receive access rights.

3.5.4 I can't change the determined listedness of a case

Argus Safety automatically sets the value of the Listedness Determination field based on the value of entries from the Event Assessment section on the Events tab of the case.

- If any of the entries appear as 'unlisted', the value of the Listedness Determination field is 'unlisted'.

- If all the entries appear as 'listed', the value of Listedness Determination is 'listed'.

- If all the entries have an unknown value, the value of Listedness Determination is 'unknown'.

- In all other cases, the value of Listedness Determination is blank.

To override this value, contact your Administrator to receive access rights.

3.5.5 I can't select the language I need for my text narrative?

If the icon representing the language you need to enter narrative in does not appear for your case, contact your Administrator to set up the respective language in the Argus application.

4 Filter cases with advanced conditions

4.1 Create a single filter

1. From the Case Actions drop-down menu, select Open.

2. In the Case Search Criteria section, from the Advanced Condition drop-down list, select New.
You are asked to confirm whether you want to create a query set (a set of filters).

3. To create a new single filter, in the Confirmation dialog box, click No.

4. Enter Name and Description of the new filter.

5. Select the types of values for the filter:

- To include values from the codelist, select From Code List.

- To include values from the case data, select From Case Data.

6. From the Properties navigation tree, select a field name or item to use as a filter.

7. From the Conditions list, select a relational operator to establish a relation between the field name and the value.

8. Repeat from step 5 to step 7, until all the filters are added.
Use the logical operators (AND and OR) to control whether all the selection criteria must be met for the case to be retrieved or that any one of the conditions must be met.

9. Click Save.

10. Click Yes if you want to share the filter with other users.
See also, Share filters with other users.

11. Click OK.

4.2 Create a set of related filters

1. From the Case Actions drop-down menu, select Open.

2. In the Case Search Criteria section, from the Advanced Condition drop-down list, select New.
You a asked to confirm whether you want to create a query set (a set of filters).

3. To create a set of filters by linking a previously defined filter, in the Confirmation dialog box, click Yes.

4. To add a filter, click Add.

5. When the new row appears in the filter selection area, do one of the following:

- To add an existing filter, click the Lookup icon ( ), click Filter, from the search result select a filter, and click OK.

- To enter a new filter criteria, click AC, and follow the procedure to Create a single filter.

6. From the Set Operator list, select an operator to link your filters.
This set operator links this filter to the next filter.

7. Repeat from step 4 to step 6, until all the filters are added.

8. Enter the Name and Description of the new filter.

9. Click Save.

4.3 Share filters with other users

Sharing filters with other users is possible only if access of the User group is defined in Argus Console through Access Management.

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.

3. To find a filter, from the drop-down list, select an option.

- Contains—Search the filters that contain the entered criteria.

- Starts With—Search all the filters that start with the entered criteria.

4. In the text box, enter the search criteria, and click Filter.

5. From the search result, select a filter, and click AC.

6. In the Advanced Condition Set dialog box, check the Share with other users checkbox.

7. Click OK.

Tip:

- If a filter is not shared with other users, the filter does not appear in the list for any user except the Administrator and the user who created it.

- If the filter is shared, all users in the system can view the filter, but cannot modify it.

- You cannot stop sharing a filter, if the filter is in use in the system.

4.4 Modify a filter

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.

3. To find a filter, from the drop-down list, select an option.

- Contains—Search the filters that contain the entered criteria.

- Starts With—Search all the filters that start with the entered criteria.

4. In the text box, enter the search criteria, and click Filter.

5. From the search result, select a filter, and click AC.

6. Update the filters, and click Save.

Note:
To save the changes as a new filter, click Save As.

4.5 Use filters to view the case series list

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.

3. To find a filter, from the drop-down list, select an option.

- Contains—Search the filters that contain the entered criteria.

- Starts With—Search all the filters that start with the entered criteria.

4. In the text box, enter the search criteria, and click Filter.

5. From the search result, select a filter, and click OK.

6. On the Case Open page, click Search.

4.6 Export the case series list to a spreadsheet

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.

3. To find a filter, from the drop-down list, select an option.

- Contains—Search the filters that contain the entered criteria.

- Starts With—Search all the filters that start with the entered criteria.

4. In the text box, enter the search criteria, and click Filter.

5. From the search result, select a filter, and click AC.

6. In the Advanced Condition Set dialog box, go to Case Series tab.

7. To list the cases that match the filter, click Find Now.

8. Select the cases from the list.

9. To save the list, click Store Case Series.

Note:
You must save the list before exporting.

10. Click Export to export the cases in CSV format.

4.7 Import a case series list from the spreadsheet and save

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.

3. To find a filter, from the drop-down list, select an option.

- Contains—Search the filters that contain the entered criteria.

- Starts With—Search all the filters that start with the entered criteria.

4. In the text box, enter the search criteria, and click Filter.

5. From the search result, select a filter, and click AC.

6. In the Advanced Condition Set dialog box, go to Case Series tab.

7. Click Import.

8. Enter the description to import the cases and click OK.

9. Browse the file to be imported and click OK.

10. Click Store Case Series to save it for later use.

Tips:

- You can import an XLS, XLSX or TXT file with one column containing case numbers.

- When you upload a text file, each line in the file is considered a complete case number.

- If a case is missing (cannot be found) or has been deleted, a message appears.

- If the same case has been entered multiple times; only one entry is retained for the same and rest are ignored after the import process is complete.

- For case series, the import process, imports 1000 cases/60 seconds.

4.8 Find filters

1. From the Case Actions drop-down menu, click Open.

2. To open the Advanced Condition Lookup dialog box, click the Lookup icon ( ) next to the Advanced Condition drop-down list.

3. To find a filter, from the drop-down list, select an option.

- Contains—Search the filters that contain the entered criteria.

- Starts With—Search all the filters that start with the entered criteria.

4. In the text box, enter the search criteria, and click Filter.

5. From the search result, select a filter, and do one of the following:

- To list the selected filters in the Advanced Condition drop-down list, click OK.

- To view the details for the selected filter in the Advanced Condition dialog box, click AC.

- To close the Advanced Condition Lookup dialog box without saving changes, click Cancel.

4.9 Access filters from the Advanced Condition Library

1. From the Utilities drop-down menu, select Advanced Condition Library.

2. From the list of filters, select a filter, and from bottom-right of the page, click an option:

- To create a filter, click New, and do one of the following:

- Create a single filter (skip step 1 and step 2)

- Create a set of related filters (skip step 1 and step 2)

- To modify an exiting filter, click Modify.
See also, Modify a filter (skip step 1 and step 2).

- To delete a filter, click Delete.

- To print a list of filters, select the filters, and click Print List.
To print the entire list of filters, check the checkbox from the heading, and click Print List.

3. To find filters for a specific time period:

1. From the Date Range drop-down list, select an option.
Or, enter date range in the From and To fields.

2. From the View options, select Advanced Condition.

3. Click Search.

4.10 FAQs

4.10.1 What is an advanced condition?

An advance condition is a filter that can be a complex or non-standard query where that uses field-level data or dictionary terms as criteria to search cases. These queries act as filters to search for cases.

4.10.2 What is an advanced condition query set?

An advanced condition query set comprises two or more filters combined to create a more complex filter. These query set act as filter to search for cases.

4.10.3 How do the logical operators work?

You can use the AND and OR logical operators to set the conditions of when the filter is used.

- The AND operator returns only those cases that match both the conditions in a filter. No case is found if one of the condition match in the filter.

- The OR operator returns cases that match either or both the conditions in a filter. No case is found if none of the condition match in the filter.

4.10.4 How do the set operators work?

You can use the UNION, INTERSECT, and MINUS set operators to combine multiple conditions in a filter.

- The UNION operator returns cases found in either filter.

- The INTERSECT operator returns only those cases that are found in each filter.

- The MINUS operator returns cases that are found in either of the filters, but not in both filters.

4.10.5 What is a case series (formerly Hit list)?

A case series is the search result of a filter or set of filters. See also:

- Export the case series list to a spreadsheet

- Import a case series list from the spreadsheet and save

4.11 What if

4.11.1 I am unable to find a filter

You may not have the access rights to use the filters. Only users with execute rights for a filter can view the filters in the drop-down list.

If you do have the access rights, you can find your filters either by using the Lookup icon ( ) (see Find filters) or from the Advanced Condition Library (see Access filters from the Advanced Condition Library).

4.11.2 I am unable to view cases that match the filter criteria

When using a set of filters to search cases, the search result is also dependent on the values entered for Date Range fields and the Initial/Follow-up selection. Therefore, if a case is not part of the Date Range for the filter, the case does not display when you click Search.

4.11.3 I am unable to view values of a codelist

The values in the Code List are configured by the administrator in Argus Console. To configure these values, refer to the Oracle Argus Safety Administrator's Guide.

4.11.4 While adding a value to a property, the Select button is disabled

The Select button is enabled only for a property whose value is a term that can be coded.

- For MedDRA related terms, the MedDRA browser appears.

- For other terms, the Product browser appears.

5 Code an adverse event term

5.1 Autocode a term

1. Open a case.

2. Select Events.

3. In the Event Information section, under Description as Reported, enter the term to code exactly as it was reported and then press the Alt+Tab keys on your keyboard.
The coding details for your term appear in the Event Coding section.

If autocoding did not succeed in finding a coding for your term, see Manually code a term.

4. To print the selected coding as a PDF report:

1. Press Encode.

2. Select the coded LLT term.

3. Press Print.

5.2 Manually code a term

1. Open a case.

2. Select Events.

3. In the Event Information section, under Description as Reported, enter the term to code exactly as it was reported and then press the Alt+Tab keys on your keyboard.
If autocoding did not find a coding for your term, the MedDRA Browser dialog box opens.

4. In the MedDRA browser dialog box, perform the following:

1. In the LLT field, refine the description of your search term using a wildcard character (%), an alternative term, or a company-specific synonym that matches your term, and then press the Alt+Tab keys on your keyboard.

Tip:
To view a specific LLT, click the LLT entry.

2. To print the selected coding as a PDF report, press Print.

3. To accept the current LLT selection as the coding for your term, double-click the LLT selection or press Select.

The coding details for your term appear in the Event Coding section.

5.3 FAQs

5.3.1 Which dictionaries does Argus Safety support?

Argus Safety supports MedDRA, MedDRA J, WHO Drug, and J Drug dictionaries. The application maintains a single version of each dictionary in the database.

In multi-tenant environments, each tenant can have its own versions of each dictionary. The J Drug dictionary is the only dictionary version that is common to all the tenants.

5.3.2 What is the MedDRA browser?

The MedDRA (Medical Dictionary for Regulatory Activities) browser is a utility that you can use to code a term such as a disease, sign, or a symptom with an internationally standardized medical term. This is a way to ensure consistent drug terminology in the Argus Safety application.

The MedDRA browser appears when you create an Advanced Condition (also known as a filter) or when you enter case details in the Adverse Event Form. You can also access the MedDRA browser from the Utilities menu.

5.3.3 What are the five levels of the MedDRA dictionary?

The MedDRA dictionary hierarchy is a categorization of medical terminology. The five levels of the dictionary are System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

The lower the level of the dictionary, the more precise the medical terminology becomes. Preferred Terms (PTs) represent medical terms you can use as the end result for coding.

For example, if the term to code is "queasy," the preferred equivalent medical term (PT) is "Nausea" in the context of the following hierarchy:

System Organ Class (SOC) = Gastrointestinal disordersHigh Level Group Term (HLGT) = Gastrointestinal signs and symptoms

High Level Term (HLT) = Nausea and vomiting symptoms

Preferred Term (PT) = Nausea

Lowest Level Term (LLT) = Feeling queasy

5.3.4 What is a synonym?

A synonym is a term or a combination of terms that nearly or exactly match the meaning of the term to code. Each organization defines its own list of synonyms for coding. To add a term to the list of synonyms, contact an Administrator.

5.3.5 What is autocoding?

Autocoding is an Argus Safety feature that Administrators can enable for terms to be automatically coded using the MedDRA dictionary. If autocoding is not enabled in the Argus Safety application, or if autocoding does not find a match for your term in the MedDRA dictionary, you must manually search and select a coding for your term in the MedDRA browser.

5.3.6 What happens if you don't enable autocoding?

If autocoding is not enabled in Argus Safety, you must manually search and select a coding for your term in the MedDRA browser.

5.3.7 What are Standard MedDRA Queries (SMQs)?

Standard MedDRA Queries are predefined sets of MedDRA terms that you can use to retrieve codings in the MedDRA browser. SMQs are developed and validated by the CIOMS Working Group and are updated for each MedDRA dictionary version.

5.3.8 What is a full search?

When you run a full search, the MedDRA browser retrieves terms that contain your search term in any word order and combination. Alternatively, MedDRA retrieves only terms that start with your search term.

5.3.9 What is a non-current term?

A non-current term is a term that you can no longer use for coding, but is retained in the Argus Safety database for historical data retrieval. A coding term can become non-current if it is vague, ambiguous, outdated, truncated, misspelled, or derived from a terminology that is incompatible with MedDRA.

Non-current terms appear next to an asterisk symbol (*) at the LLT level in the MedDRA coding browser and in the search results list.

5.3.10 How can I view details for a coded term?

To view details for a coded term such as the dictionary version it was coded against, or SOC, HLGT, HLT, PT, LLT level values, click the green check mark next to Event Coding on the Case Details or new Advanced Condition form.

5.3.11 How can I narrow my search in the MedDRA browser?

To narrow your search for a coding, you can use one of the following options in the MedDRA browser:

- To search for the term in a specific Standard MedDRA Queries (SMQs) category, select the category from the MedDRA SMQ drop-down list.To search for the term across all dictionary levels, enter the term in Search All Levels and press the Enter key on your keyboard.To search for the term against any combination of terms that includes your term, check Full Search.To search for the term also against codings that may not be included in the selected dictionary version, click Include Non-current terms.

5.3.12 Why does a dictionary coding appear highlighted in yellow in the MedDRA browser?

A yellow highlighted coding in the MedDRA browser represents the primary System Organ Class (SOC) path for a term with more than one path or SOC.

5.3.13 Why can't I use the Export button to export a coding?

The Export functionality is reserved for Administrators.

5.3.14 What is Null Flavor data?

Null Flavors are used to describe the reason for missing data. ICH E2B(R3) and regional agencies such as CBER, EMA, MFDS, and PMDA have published guidelines on the allowed Null Flavors for various fields that are part of the E2B(R3) report. A Null Flavor set is a collection of Null Flavors. Sets are provided by default for various combinations of Null Flavors in the Flexible Re-categorization Codelist.

Null Flavor data can be selected for fields in the Case Form by clicking on the Null Flavor button ( ) next to the fields. On clicking the button, a drop-down list appears and allows you to select Null Flavor data as configured in the Field Properties Configuration in the Argus Console. The background color of the NF button changes (from grey to blue) when a Null Flavor is selected from the drop-down list.

When the Case Form field has data and the user clicks the button, the system displays a warning message that data will be cleared on switching to the Null Flavor field. The data is cleared or retained based on user confirmation. When data pertaining to the field is received, Null Flavor data can be overwritten by actual data by clicking the NF button.

5.4 What if

5.4.1 Autocoding is not enabled in my application

If your Administrator did not enable autocoding in the application, you must manually search and select a coding for your term in the MedDRA browser.

5.4.2 Autocoding is unsuccessful

If your Administrator enabled autocoding, but autocoding did not find a coding from the MedDRA dictionary for your term, the MedDRA Browser dialog box appears on the screen for you to manually search and select a coding for your term.

To attempt autocoding a second time, refine the description of your search term in the LLT field using a wildcard character (%), an alternative term, or a company-specific synonym that matches your term.

The application populates the fields in the Event Coding section with the details of a MedDRA coding match.

5.4.3 I receive a "No Records Found" message when I manually code a term

If you received a "No Records Found" message when manually coding your term in the MedDRA browser, you can refine the description of your search term in the LLT field using a wildcard character (%), an alternative term, or a company-specific synonym that matches your term.

5.4.4 The coding I previously used for a term now features an asterisk and can no longer be selected in the MedDRA browser, as it is labeled as non-current

If one of your active cases contains an adverse event term that has been coded with a term that now appears next to an asterisk symbol (*), you must code the term a second time for the respective case, or ask an Administrator to recode the term for you using the MedDRA recoding tool.

6 Manage your Expedited Report submissions

This chapter lists tasks related to preparing, submitting and tracking compliance for Expedited Reports (ICSRs - Individual Case Safety Reports).

6.1 Schedule an Expedited Report

6.1.1 Schedule a report manually

1. Open the case for which the report has to be scheduled.

2. When the system displays the Case Form for the selected case, select Regulatory Reports, and then select Schedule New Reports.

3. When the system opens the Schedule New Expedited Report dialog box, enter the appropriate information in the fields in the dialog box:

Field

Description

Aware Date

If an Aware Date is appended with '(A)' in the drop-down list, it is used to denote the aware date of an Amendment.
The resulting expedited report Due Date is based on the selected Aware Date and the duration of the Due Date section.

The selected Aware Date has no impact on the Actual Due Date if the user specifies an absolute Due Date. For instance, selecting a date in the Due Date field causes the report to be due on the specified date, regardless of the selected Aware Date.

This drop-down list is only populated and enabled after a license has been selected. The Aware Dates are displayed in descending order of the Current Aware Date.

Protect Confidentiality of Patient and Reporter

Check this checkbox if identifying information about the patient and the reporter must not appear on the report.
The system also displays 'MSK' null flavor in the eVAERS report when this checkbox is checked. MSK is populated only when the data element contains some data and is not null.

4. Click OK.

To view all scheduled reports, go to Reports, then select Compliance, and click Expedited. Alternatively, you can go to Worklist, and select Reports.

6.1.2 Auto-schedule a report

1. Open the case for which the report has to be scheduled.

2. Select Regulatory Reports, then select Auto Schedule or Auto Schedule Device.

Reports will be scheduled against the reporting rules which have been set up by the administrators.

6.1.3 Create unscheduled expedited reports

1. Select Reports, then select Compliance, and select Expedited.

2. Click Batch Print or Create Report and search for the case for which the expedited report has to be scheduled.

3. When the system displays the search results, select the locked cases for which the expedited report is to be scheduled.

4. Click Batch.

5. When the system opens the Batch Print or Create Reports dialog box, enter the appropriate information and click OK.

The system generates the unscheduled expedited report.

Field

Description

Suspect Product

Displays the Trade Name for which the report has been scheduled. A (+) displayed at the end of the Product Name denotes that more than one Suspect Company Product exists.
For Reports which were scheduled for the Device, the Device name gets displayed.

F / LT

Denotes Fatal / Life Threatening
If the case is both F and LT, only F is displayed.

If the case is neither F nor LT, No is displayed.

7/15

Displays 7 if the report is due within 7 days
Displays 15 if the report is due in more than 7 days

6.1.4 Batch print or create reports

You can use the Batch Reports function to schedule and generate reports for multiple cases. Before using this function, verify that no cases or reports are open.

1. Select Expedited Reports from the Reports - Compliance menu.

2. When the system opens the Expedited Reports dialog box, click Batch Print or Create Report.

Field

Description

Suspect Product

Displays the Trade Name for which the report has been scheduled. A (+) displayed at the end of the Product Name denotes that more than one Suspect Company Product exists.
For Reports which were scheduled for the Device, the Device name gets displayed.

3. When the system opens the Expedited Reports dialog box, search for the cases for which the expedited report needs to be scheduled.

4. When the system displays the search results, select the appropriate cases and click Batch.

5. When the system opens the Batch Print or Create Reports dialog box, enter the appropriate information in the fields and click OK

The Expedited Batch Printing dialog box supports printing Batch CIOMS, Medwatch, and VAERS on Argus Web locally.

Batch Print or Create Reports dialog box—Fields and Field Descriptions

Field

Description

Format

Enables you to print reports As Draft or As Final.

- The Print As Final option is available only if all the selected cases are locked.

- If Print As Final is selected, then the option Save with case, mark as submitted is also available as a checkbox option.

- Click the options Print As Final and Save with case, mark as submitted to generate final Regulatory Reports and create a submission record with each case identical to the current functionality.

- Click the options combination of Print As Final only (and not Save with case, mark as submitted) to generate final Regulatory Reports without creating a submission record with each case.

- If the report is associated with a blinded study, select the Blind study product checkbox.

Destination

Check the Printer checkbox to print the report

Protect Confidentiality of Reporter and Patient

Check this checkbox to hide the Reporter and Patient information on the expedited reports.

Scheduling

1. If Run Now is selected, all the selected reports run against all selected cases and a PDF is generated.
The Run Now option is visible only when a MedWatch, MedWatch Drug, CIOMS, or VAERS form is selected on the Batch Expedited Report screen.

If you select an unlocked case, the report gets printed in draft form only and is not saved.

2. Select Run at and enter the appropriate date and time when the generation of reports should occur.

6.1.5 Review a draft Expedited Report

1. Open the case for which you want to view a draft report.

2. Click the Regulatory Reports tab.

3. From the Total Number of Rows tab, locate the relevant report and click Draft to view the report.

4. Alternatively, click the Draft Report icon on the top right of the screen.

1. From the View Draft pop-up, select the Report Form, Destination, and Product.
The Report Form drop-down displays the list of expedited reports and the Destination drop-down displays the list of reporting destinations configured in Console. Based on the report form and destination, the products are displayed as explained below:

- For the Drug Report Forms, the left most suspect product with the drug license that matches the agency country is displayed as default.

- For the Device Report Forms, the left most suspect product with the device license that matches the agency country is displayed as default.

- For the Vaccine Report Forms, then left most suspect product with the vaccine license that matches the agency country is displayed as default.

When no product with license matches to the license type and agency country in the case, then the primary suspect product is displayed, that is left most suspect product in the Product tab.

- For the Drug Report Forms, the drug license with earliest award date of the selected product that matches the agency country is used to generate reports.

- For the Device Report Forms, the device license with earliest award date of the selected product that matches the agency country is used to generate reports.

- For the Vaccine Report Forms, the vaccine license with earliest award date of the selected product that matches the agency country is used to generate reports.

2. Click OK.
The report is generated in the draft mode.

6.1.6 Review your scheduled reports

The Regulatory Reports tab enables you to view all scheduled reports.

When a new case is created, there are no reports associated with it. As data is entered and the case is saved, the regulatory report scheduling algorithm determines which reports, if any, are required for that case.

The reports determined to be necessary appear in the Regulatory Reports tab. You can manually schedule reports through the Reports menu or by clicking the Regulatory Reports tab. You can also add comments to existing reports. The comment section can be updated to enter notes for a report even after it has been submitted.

- The case submission date must be on or after the initial receipt date for the case. If the submission date is before the initial receipt date, the system displays an error message.

- The system displays the time component for the date generated on the Case Form > Regulatory Reports tab using the IE offset of the client machine for the display.

- The system displays the time component for the date generated on the Report Details using the IE offset of the client machine for the display.

- When you manually schedule an Expedited report, the system places the word, Manual, in the Notes field along with the current notes information.

6.1.6.1 Review a list of your scheduled reports

- Go to Reports, then select Compliance, and then select Expedited Reports.

You can print draft expedited reports from the Batch Print or Create Reports without printing DRAFT on the reports from the Case Open or the Reports | Compliance | Expedited Reports dialog box.

6.1.6.2 View your scheduled reports

- To view scheduled reports, hover over the Worklist menu and select Reports.

When the system opens the Reports screen, enter the appropriate information as necessary.

6.1.6.2.1 Report filter options

- The search results appear in the Report Details dialog box and permit the user to enter the approval notes that are applied to all selected reports. The system skips any reports selected by the user that have the following statuses:

- Scheduled

- Disapproved

- Approved

- The system hides the reports fields from the report details dialog box and does not permit the user to access or modify any other tabs.

- The system hides the Route button to prevent users from modifying the Report Status.

Option

Description

Reporting Destination

Displays the report destination (agency) for which the report is scheduled.

Report Status

Displays the status of the report as Approved, Generated or Scheduled.

Report Form

Displays the description of the report.

Filtering Reports

You can click the respective magnifying glass icons to filter reports based on Destination, Product Family, and Country of Incidence. The system displays the standard lookup dialog box.

By Destination

The Report Destination filter multi-selection screen list contains the names of all agencies as configured in the Argus Regulatory Authority CodeList.

By Product Family

The Product Family filter multi-selection screen contains a list of all product family names as configured in the Argus Products codelist.

By Country of Incidence

The Country of Incidence filter multi-selection screen contains a list of all available countries.

6.1.6.2.2 View filter results

The Total Number of Rows section displays the result based on the selected filter criteria with following details:

Field

Description

Selected

Allows the user to select one or more reports, on which actions can be performed.

Suspect Product

Displays the Trade name for which the report has been scheduled. A "+" displayed at the end of a Product Name indicates that more than one Suspect Company Products exist.
A Device Name is also displayed for those reports which were scheduled for the Device.

Diagnosis

Displays the Primary Event Diagnosis PT.

Event Verbatim

Displays the event verbatim (verbatim as reported) of the Primary Event.

F or LT

Indicates whether a case is fatal or life threatening as follows:

- F identifies a Fatal (F) case

- LT identifies a Life Threatening (LT)

If any of the above are present together, then Fatal takes precedence followed by LT. If the case is neither of the above, No is displayed.

7/15

Displays 7 if the report is due within 7 days.
Displays 15 if the report is due in more than 7 days.

Report Form

Displays the description of the report.
Click the link to view the DRAFT report PDF.

Initial / Follow-up (#)

Displays if the report is Initial or Follow-up.
If it is a Follow-up, the follow-up number is printed.

Downgrade

Displays Yes if the report is a Downgrade report.

View Report

Enables the user to view the report as a PDF.

Local Labeling

Enables the user to view the local labeling dialog box.

- This option is available only if the user has access to Local Labeling within the groups to which the user belongs to.

- The Local Labeling can also be viewed by clicking the local labeling icon that is displayed next to S/U/R.

6.1.7 View Expedited Report status

1. To review the status of expedited reports, select Dashboards, and then select Expedited Report Status.

2. In the Search Case section, enter the parameters, and click Retrieve.

3. To view a list of cases, click the relevant section of the pie chart or bar chart.

Note:
When you have access to Expedited Report Status, you also have access to the Report Due Soon dashboard.

6.2 Submit your Expedited Reports

6.2.1 Generate an Expedited Report

You can generate a report using either of the following procedures.

Method 1: Generating a report

1. Verify that the relevant case has been locked and the required report has been scheduled.

2. Open the selected case to display its associated Case Form.

3. Open the report from the Regulatory Reports tab of the Case Form.

4. When the system opens the Regulatory Reports details for the selected case, locate the relevant report and click the Final link to generate the report.

Method 2: Generating a report

1. Verify that the relevant case has been locked and the required report has been scheduled.

2. Select Case Actions, and then click Open to view the Case Open form.

3. Click Search to view cases matching the search criteria.

4. When the system displays the search results, click the Lock State icon and select Case Details.

5. When the system opens the Argus Safety Case Details dialog box, open the Scheduled Regulatory Reports folder and select the relevant regulatory report.

Note:

- You do not need to lock the case to preview a report in draft mode.

- If you have access rights to view or print blinded information, you are prompted to select whether you would like to view a blinded or unblinded version of the report. If your access rights disallow you from viewing or printing unblinded information, you can view only a blinded version of the expedited report. The following items are not displayed when viewing a blinded version of the expedited report:

- Clinical Treatment Given (Study Drug field)

- Study Drug Formulation and Concentration

- Study Drug Dose, Daily Dose and Route

- Study Drug Batch/Lot # and Expiration Date

- If the case is locked you can generate the report from the Worklist | Reports, Reports | Bulk Reporting and Reports | Compliance | Expedited screens.

6.2.2 Approve your report

1. Open the case associated with the report that needs to be approved.

2. When the system opens the Case Form, click the Regulatory Reports tab to displays the case details.

3. Click the icon associated with the report you wish to approve and select View Report Details.

4. When the system opens the Report Details dialog box, click the Routing tab.

5. When the system opens the Routing tab, select Approved from the State drop-down list and click Route.

6. When the system opens a dialog box, enter the required information and click OK to approve the report.

6.2.3 Transmit an ICSR

To transmit reports one by one, select Reports Detail Dialog, and click the Transmit tab.

- Go to Case Actions, then click Open, and select Regulatory Reports. Left-click on the Status icon, and select Transmit.

- Go to Report, then select Compliance, and select Expedited. Left-click on the globe icon to show the report details, and select Transmit.

The Transmit tab enables you to transmit a case electronically.

1. Select the recipient from the Available Recipients list.

2. Select the transmission method from the Method list.

3. Enter any comments under Comments.

4. Click Transmit.

6.2.4 Transmit several ICSRs at once

To transmit several reports at a time, go to Reports and select Bulk Reporting, then select Print Regulatory Report and click Transmit. Select the cases you wish to transmit, and click Transmit at the bottom of the screen.

The Bulk Transmit function lists the status for all transmission events against your assigned cases.

To view the Bulk Transmit page, hover over the Worklist menu and select Bulk Transmit.

6.2.4.1 Filter reports

The Total Number of Rows section displays the search result based on the filter criteria.

Field

Description

Report Form

Displays the description of the report.
Click the link to view the DRAFT report PDF.

Recipient Company

Displays the name of the company of the report recipient

Date Created

Displays the date on which the report was created.

Date Sent

Displays the date on which the report was transmitted to the recipient.

# of Pages

Displays the number of pages in the report.

Attempts

Displays the number of attempts made to transmit the report. If you are using Right Fax, the value of this field is displayed as 0 even if the Right Fax had attempted it multiple times. This is an unsupported feature in Right Fax.

Sender

Displays the name of the sender of the report.

Lock State

Displays the lock status of the report.

Sender Agency Name

Displays the name of the agency that has generated the report

Status

Displays the Report Status such as Scheduled, Generated, and so on.

6.2.4.2 User options

Option

Description

View Transmission

Displays the report in a PDF format.

Mark report as Submitted

Marks the report for the selected row as submitted.
This option is displayed to only those users who have the access rights to mark a report as submitted.

Remove transmission

Failed transmissions can be removed using this option as it removes the transmission log entry from the list.
A report whose status is pending cannot be transmitted.

Re-transmit

This options allows reports to be re-generated and re-transmitted if report generation had failed earlier. For failure in other stages of report transmission, this option performs only retransmission.

Submit Multiple Reports

Multiple reports that are selected from the list can be marked as submitted simultaneously.

Re-transmit Multiple

The status of multiple reports that are selected from the list can be changed to pending, and those reports can be re-transmitted.

Remove Multiple Transmissions

Transmission of multiple reports that are selected from the list can be removed.

6.2.4.3 View routing details

- Enter routing details in the text box.

Reports that appear in the Bulk Transmission section or the Bulk Print section do not display in the Reports section of the Worklist.

6.2.5 Print your reports

The Bulk Print function displays a separate list for all Bulk Print events against reports.

1. Hover over the Worklist menu and select Bulk Print.

2. When the system opens the Bulk Print page, enter the appropriate information.

6.2.5.1 Bulk print user options

Option

Description

Remove Print Job

Removes the print job entry from the list.
A report whose status is pending cannot be printed.

Re-print

This option is displayed if the selected row has a status of failure or success. Select this option to change the status back to pending and the re-print the report.

Submit Multiple Reports

Multiple reports that are selected from the list can be marked as submitted simultaneously.

Re-print Multiple

The status of multiple reports that are selected from the list can be changed to pending, and those reports can be re-transmitted.

Remove Multiple Print Jobs

Print jobs of multiple reports that are selected from the list can be removed.

6.2.6 Store Expedited Reports in Documentum

Argus Safety lets you store your Expedited Reports in Documentum.

- Mark an Expedited Report as submitted from within Argus to insert the report into the Documentum system as a PDF.

- If the report is to be transmitted via fax or email, Argus Safety Service marks the report as a successful submission in Documentum only after the fax or email transmission has succeeded.

6.3 Track your Expedited Report submissions

6.3.1 Track ICSR outgoing status

1. To monitor the Outgoing messages and Acknowledgements, go to Utilities, then select ICSR, and click ICSR ICSR Transmit Status.

2. In the Search Reports section, enter the search criteria, and click Search.
The search results appear in the Total Number of Rows section.

If the Agency is selected as Any, the search results display all ICSR messages and acknowledgements for all receivers.

6.3.2 View ICSR transmit status

The Bulk ICSR Transmit function displays only those ICSR Reports that are awaiting submission (not in submitted state) when transmitted from Bulk Report By Form to the Trading partner.

1. Hover over the Worklist menu and select Bulk ICSR Transmit.
The Bulk ICSR Transmit page appears with following tabs:

- Reports—Displays the status of individual ICSR Reports that are in the process of being transmitted.

- Messages—Displays the status of ESM Messages which may contain multiple reports.

2. Once reports have been successfully submitted and marked as submitted, they no longer show when you go to Worklist and select Bulk Transmit, when you go to Worklist and select Bulk Print, or when you go to Worklist and select Bulk ICSR transmit. To find a list of all successfully submitted cases, go to Reports, then select Compliance, and click Submitted.

3. Alternatively, go to Utilities, then select ICSR, and click ICSR Transmit Status.

6.3.2.1 Search for reports

On the Reports tab, select the options to search for reports.

Field

Description

Report

Select the type of report from the drop-down list, as applicable.
Select E2B, eVAERS or eMDR from the list to view the transmission status of the report.

Message Type

Select a pre-defined message type.This field is set to ichicsr and is disabled if report is set as eMDR or eVAERS.

Periodic Report

This field is enabled for message type that are marked as Periodic in the Message type codelist.
This field is disabled for eVAERS and eMDR.

Range

Select a date range.

Search button

Triggers search based on the search criteria.

Only show transmissions that have reached a failure state

Check this checkbox to search for only those transmissions that have a failed status.

Show all transmissions (submitted and unsubmitted) having a error ACK

When this checkbox is checked by the user during the Search action, the system brings back any ICSR report that has received an error ACK (acknowledgement), irrespective of whether it has been marked as submitted or not.
When this checkbox is checked, the checkbox Only show transmissions that have reached a failure state is automatically unchecked.

Stage Legend

Shows the status (through colors) corresponding to each stage.

6.3.2.2 Search for ESM messages

On the Messages tab, select the options to search for ESM messages.

Field

Description

Report

Select E2B, eVAERS or eMDR from the drop-down list to view the transmission status of these reports.

Agency Trading Partners

Enter the agency or trading partner.

Transmit Date Range From

Select the transmit date range.

Range

Select a range to auto-populate the Start Date and End Date.
The Range option is cleared if the Start Date or End Date is changed.

6.3.2.3 View search results

The Total Number of Rows section displays the search result based on the search criteria.

If the ICSR report in a result set row was already submitted, the system does not display the following pop-up windows:

- Remove Transmission

- Re-Transmit

- Mark as Submitted

- Re-Transmit Multiple

- Submit Multiple Reports

- ICSR Transmission History

For the same record above, the system, however, keeps the View Report Details and View ICSR Report menus enabled.

Option

Description

View Acknowledgement (Read only)

Displays the Acknowledgment report.
This menu option is not displayed if ACK has not been received for message.

View xml acknowledgement

Displays business level acknowledgement.

View Reports

Opens the Bulk Transmit ICSR in the report view for all the reports in the message.

View Report Details
(read -only)

Opens the existing Report Details dialog box in read-only mode.

View ICSR Report
(ICSR Viewer for the report)

Opens the existing ICSR Viewer report.

ICSR Transmission History
(Transmission History for the selected report)

Opens the new Transmission History screen.

6.4 Manage your Incoming ICSRs

To view the Incoming ICSR Reports screen, select Reports, and then click ICSR Pending Reports. You can:

- View the ICSR reports sent by the agency or the trading partner.

- Process an incoming ICSR report.

- Check all the ICSR values of the reports sent and determine whether to accept or reject the reports.

- Provide a user password and acceptance notes/rejection reason and accept or reject an incoming ICSR report.

6.4.1 Track incoming ICSR reports

Field

Description

Message Type

Allows selection of ICSR based on the message type for all allowed values for the N.1.1 tag. By default, the drop-down is populated as ichicsr.

Trading Partner

1. To view report by a Trading Name, click Filter and select an agency.

2. To select multiple agencies, click Add in the Select Reporting Destinations dialog box.

Product Name/Generic Name

Click the Select button next to this text box.
A pop-up screen appears with a text box (2000 characters), a Search button, an OK button, and a Cancel button.

This pop-up screen is called "Generic Name" or "Product Name" as per the radio button selected in the Incoming ICSR Reports for which this popup was being invoked.

This pop-up screen is titled "Product Name" when invoked from the Processed ICSR Reports screen. The text box in the pop-up screen is auto-populated with text entered in product name or generic name field on the corresponding screen but can be the user updated.

Besides, when the user switches tabs between the Pending and Processed Sub Tabs, the default processing page icon appears which information that it is still processing and switching is not completed.

Initial / F-U / Nullification/ Amendment / Downgrade

The report version of the report for the case received.

Country of Incidence/ Primary Source Country

Displays the country where the incident occurred.

Is/Will be assigned to this site

Displays the site membership of the case.
This field appears in the search result.

Accept ICSR

Imports ICSRs in a batch from ICSR Pending screen after selecting one or more reports (E2B(R2) and/or E2B(R3).

6.4.1.1 Button and right-click options

Button

Description

ICSR Viewer

Select this right-click option to launch the ICSR viewer. For details, refer to the ESM User Help.
Note: At the time of generating an ICSR report, some characters entered in the case form may not be displayed the same in the ICSR report. For example, the ICSR report equivalent of the "&" character entered in the case form is &. Similarly, there are other such characters that are represented differently in the ICSR report.

View Error/Warning Message

Select this right-click option to view all warning messages including M2 validation errors and Multiple ICSR Codes log.

Accept ICSR

Selects the incoming ICSR report for both single and multiple acceptance.
Execute these steps to accept an ICSR Case:

1. Click the Accept ICSR Case button. The Acceptance of Initial Report Confirmation dialog opens.

2. Enter your user password, date, and select a justification from the pre-defined list of justifications.

3. Click OK.

Accepting Amendment report is the same accepting a Follow-up report. The application supports importing attachments for the file types as configured in the profile switch Case Processing -> Valid attachment file type.

View Validation Failure

Opens the ICSR validation report (pdf) in the same format as it does at the time of export. This validation report prints all the validations that are categorized as soft validations for the import. Applicable for (R3) based ICSR reports only.

Duplicate Search

Select this right-click option to perform Duplicate Search for the case being imported with the case present in the system.

6.4.2 Manage pending reports

When using ICSR Pending reports, right-click the row and select the following:

- Case Summary

- Medical Summary

- Case Form Print

6.4.3 Track bulk incoming ICSR reports

The Bulk Incoming ICR Reports enable you to import multiple ICSR reports that are sent by the agency or trading partner. To view the Bulk Incoming Reports:

1. Select multiple reports from the Incoming ICSR Reports screen.

2. Click Accept ICSRs.

Note that:

- The reports that are imported can be a combination of Initial, Follow-up and Nullification reports.

- The only pre-requisite for this dialog box is that Case numbering should be set to auto-numbering and not manually.

- Bulk Incoming Reports does not prevent the duplicate cases to be loaded into the system.

The following table lists Bulk Incoming Reports fields.

Field

Description

Agency Name

This drop-down list contains unique trading partner from the ICSR reports have been received.
Select an agency/trading partner to filter the ICSR reports.

Product Name

This drop-down list contains unique suspect Product Names extracted from the received ICSR reports.
Select a suspect product to filter the ICSR reports. If an Agency Name is selected, the Product Name list contains all suspect products belonging to that agency name.

Follow Up Output Format

This drop-down list contains CIOMS-I, MedWatch and Case Form. You can print all ICSR reports only if the Follow Up checkbox is checked.

Source Count

Displays the total number of ICSR reports with breakdown in 'Initial' 'Follow Up' and 'Nullification' category.

Selected Count

Displays the number of ICSR selected by the user to load the ICSR reports in Argus Safety. Selected count can be changed by checking the 'Initial' or 'Follow Up' or 'Nullification' checkbox.

Import

Imports all the reports.
Note: For the Import process, if the system receives an ICSR report with the Medically Confirm field set to 1, the Primary reporter is marked as HCP.

Cancel

Removes the Import ICSR reports window.

6.4.4 Search for duplicate reports

The Duplicate Search dialog box for an ICSR report enables you to search for possible duplicate cases in the Argus Safety system. You can select different combinations of search criteria. When more than one criterion is selected, only cases that satisfy all criteria are listed. By default, the fields that are present in the ICSR Report are checked for the Duplicate Search.

6.4.4.1 View duplicate search options

Field

Description

Onset Date

The date from when the first reaction or adverse event occurred.

Reference #

National Regulatory Authority's Report Number, used as a Reference Number.

ICSR Viewer

Enables you to view the E2B report.

MIR Viewer

Enables you to view the MIR report in XML and PDF formats.

View Differences

Allows viewing differences between the current XML to be imported (a message that is not yet imported into the database), the current case data in the database, and if a case has been imported before, the last imported case.
Note: This button is available only for follow-up and nullification reports.

Action

Enables you to view the Case Summary dialog box.

Reporter

Displays the reporter involved with the case matching the search criteria.
This field appears in the search results.

Reference ID

Searches on the following fields in the Argus case:

- Additional Info | Case Reference ID

- Reporters | Reporter's Reference #

- Argus Case Number

Keyword

By default, the first value from the incoming affiliate event appears.

6.4.4.2 Search duplicates for incoming review

The Duplicate Search in Argus Central Incoming review enables you to search on Reference ID and Keyword field in Argus cases.

You can right-click the Case Number for a listed case and use the following options:

Right-click Option

Description

Case Form Print

This option is displayed for only those users who belong to the group with access to Argus Console > Access Management > Groups > Menu > File > Print.
This option allows you to print the case form report.

Case Summary

This option is displayed for only those users who belong to the group with access to Argus Console > Access Management > Groups > Menu > File > Open Case Summary.
This option allows you to open the summary report of the case.

Medical Summary

This option is displayed for only those users who belong to the group with access to Argus Console > Access Management > Groups > Menu > File > Print.
It displays the medical summary of the case.

Unlock/UnArchive Case

This option is displayed to allow users to re-open the archived and locked cases. On clicking this option, a Locked Case/Archived Case screen (as applicable) is displayed. You need to enter your password along with any remarks/notes and select a reason for your action to complete the unlocking/unarchiving of the case.

Note: This option is available only when the case is in locked/archived status, and if the user has privileges to lock/close the case, as per Console User Configuration > Case Form settings.

6.4.4.3 View differences report

You can view differences between the current XML to be imported (a message that is not yet imported into the database), the current case data in the database, and if a case has been imported before, the last imported case.

Note: View Differences is available for follow-up reports only. This option is enabled only when an initial case or case number is selected in the duplicate search output section.

To view the View Difference report:

- From the Duplicate Search screen, click View Differences.
The ICSR Difference Report screen appears.

The differences in the ICSR reports appears as:

- Addition—New elements are highlighted in grey.

- Deletion—Deleted elements are highlighted in red.

- Modification—Modified elements are highlighted in yellow.

The following table describes the fields in the report.

Field

Description

Trading Partner

Allows you to view the Trading Partner name from whom the ICSR report is received.
Note: The Lock/Archive icon displayed with this field denotes the status of the case.

DTD Version

Allows you to view the DTD version of the follow-up ICSR report.

Case Number

Displays the original case number of the ICSR report.

Follow Up #

Displays the sequence number of the follow-up for the E2B report.

Total Number of Rows

Allows you to select the type of ICSR Difference to view from: Current ICSR vs. Current Case in Database

- Current ICSR vs. Last Imported ICSR

- Current Case in Database vs. Last Imported ICSR

Import

Highlights the import differences.

ICSR Element

Highlights the ICSR differences.

Current ICSR

Highlights the differences in the current ICSR.

Current Case in Database

Highlights the differences in the current case in the database.

Last Imported ICSR

Highlights the differences in the last imported ICSR.

Accept Follow-up

Allows you to update the corresponding fields for the selected ICSR elements in the Argus case.

Reject Follow-up

Does not update the corresponding fields for the selected ICSR elements in the Argus case.

Print List

Provides the difference report in a PDF format.

6.4.4.3.1 Accept initial E2B cases as follow-up

This option is enabled only when an initial case or case number is selected in the duplicate search output section.

1. To add an ICSR as a follow up to the Case Number (that is highlighted in the duplicate search output section), click Accept Initial E2B Cases As Follow-Up.

2. Click OK when the following pop-up dialog box appears:
"Do you want to add this ICSR as a Follow-up to the Case Number<Num>?"

The Argus application attaches the incoming ICSR as a follow-up, to the selected case number highlighted in the duplicate search screen.

6.4.5 View processed ICSR reports

The Processed ICSR Reports page contains a list of ICSR that are processed successfully or processed with Errors/Warnings.

6.4.5.1 Search for reports

Field

Description

Trading Partner

- To filter based on the Trading Partner, click Filter, and select an agency.

- To select multiple agencies, click Add from the Select Reporting Destinations dialog box.

Product Name

Enables you to select a Product Name as a search criterion.

- For Product Name from Processed E2B Reports—searches all the Product Names for all the processed cases.

The result set is limited to 1000 rows.

To update the Product or Generic Name, selects a value from the search result, and click OK.

6.4.5.2 View search results

The search results appear in the Total Number of Rows section.

Field

Description

Interchange Date

Displays the Case Number with which the case has been imported on the specified interchange date.

ACK GEN Sent

Displays the status of the ACK GEN.

- Yellow—Import is pending

- Orange—Import is accepted but with warnings or errors

- Red—Import is rejected

- Green—Successful import

EDI Out

Displays the EDI Out status.

- Yellow—Pending to send the report out of the EDI / XML or PHY out folders

- Green—Already sent out of the EDI / XML or PHY out folders

- Red—EDI gateway failed to send the report out of the EDI / XML or PHY out folders

Warnings / Errors

Click binoculars icon to view warnings/errors associated, if any.

6.4.6 Track ICSR incoming status

To monitor incoming ICSR:

1. From Utilities, go to ICSR, and select ICSR Receive Status.

2. In the Search Reports section, enter the search criteria, and click Search.
The search results appear in the Total Number of Rows section.

If the Agency is selected as Any, the search results display all ICSR messages and acknowledgements for all receivers.

3. Click the Type Icon link to view message options.

6.4.7 View message options

- Click the Type icon to view the options:

- Any—Displays all the ICSR messages and acknowledgments.

- MSG—Double-click MSG to view messages in the ICSR Viewer.

- ACK—Double-click ACK to view the acknowledgement.

When you click any above-mentioned option, the Message Acknowledgement screen appears.

This screen contains all the safety report detail information such as, if the report is loaded or not loaded with error and enables you to monitor message acknowledgements.

6.4.8 Find overdue reports

1. On the Home page, hover over the Worklist menu and click Reports.

2. Click on the field Days Past Due on the right of the Total Number of Rows and if needed click again to show Days Past Due in descending order (arrow pointing downwards).

3. To view all reports select ALL at top right of the screen.

For details on entering data in each section of the Total Number of Rows tab, see Total Number of Rows link.

6.5 FAQs

6.5.1 What is a scheduled report?

A scheduled report allows the system to calculate a report based on the date received, seriousness criteria, and reporting rule configuration if any. You can schedule any report. The case data within the reports continues to be updated as the case is updated.

6.5.2 What is a generated report?

A generated report creates a draft report for review. The case needs to be locked for the system to generate a report.

6.5.3 What happens when a report is approved?

Approving the report allows the User to sign off the report.

6.5.4 What is the difference between submitting and transmitting a report?

A report can be submitted to a regulatory authority either by printing it off and marking it as submitted, or sending it electronically from within Argus via fax, email or E2B. Transmission is the electronic form of submitting a report.

6.5.5 What happens when manually scheduling a Local Japan report?

On Manual Scheduling of a report by a user, the application identifies if the report is a Local Japan report by matching the Country of the License#, Destination and Report Form chosen by the user in the "Schedule New Report" manual report scheduling dialog box with the "Local Reports Configuration".

If DLP is not enabled for Expedited Report Generation:

1. On the Global lock of a case by a user, the application generates the global reports but does not generate any Local Japan reports.

2. The Local Japan reports shall be generated on subsequent local lock for Japan.

If DLP is enabled for Expedited Report Generation, refer to the chapter in Oracle Argus Safety Japanese User's Guide > 4 Reports.

For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan report by matching only the Destination and Report Form chosen by the user.

For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan report by ignoring the country, matching only the Destination and Report Form chosen by the user and if the Truly Local Case switch returns value > 0.

Note that if AUTO_FOLLOWUP_MANUAL switch is ON, the existing functionality of scheduling a follow-up report for a manual report is retained as is and if the manual report was a local report, the follow-up is treated as a local report.

6.5.6 What happens when auto-scheduling a Local Japan report?

On the Global lock of a case by a user, the application triggers the qualifying reporting rules including the Japan reporting rules and schedule the relevant global and local reports. There are modifications to the Report Generation functionality however, and is explained under section Changes to Report Generation.

On the Local Lock of a case by a user, the Local Reporting Rules for Japan are triggered again as follows, depending on the value in the configuration switch "Case Form Configuration | Auto Regulatory Scheduling":

- If the value is set to Always: The Local Japan reporting rules are triggered on case save during the follow-up cycles of case processing when any of the local fields caused the "Significant" data change. If any of the other fields caused the "Significant" data change, then all the reporting rules are triggered as with the existing algorithm. Also, for the initial case cycle, only local reporting rules are triggered on Local lock.

- If the value is set to Significant: The Local Japan reporting rules are triggered on Local Lock but respecting the existing algorithm to check that Significant Follow-up was added during the prior global lock cycle during the follow-up cycles. For the initial case cycle, as with the existing algorithm, they trigger on Local lock.

- If the value is set to any value other than None, including Manual: A new checkbox called Schedule Local Reports Only will be added under the Total Number of Rows section in the Regulatory Reports tab of the Case Form. This checkbox is visible only when the configuration switch Case Form Configuration > Auto Regulatory Scheduling is not set to None. After the rules are successfully triggered, the application unchecks the checkbox. If the checkbox is unchecked, the application triggers all the qualifying reporting rules keeping the current functionality.

Note:
As a result of triggering of local reporting rules again, the Local reports that were already scheduled during Global Lock may result in being overwritten or being removed.

Force Distribution: If force distribute is checked for a reporting rule, the application triggers that reporting rule as per the existing functionality. However, the generation and force distribution of the Local Reports have the following modifications:

a. When a Local reporting rule marked for "Force Distribute" has a local report that has become due, the report is scheduled, generated and force distributed by performing the global and local lock on the case using the existing AG Service Force Reporting process.

i.When a Local report that was already scheduled outside of the force distribution process from a local reporting rule marked for "Force Distribute" has become due, the application does not force generate this report keeping it consistent with the existing functionality.

b. For the above scenario, AG Service uses the one step global/local lock comment "Case Globally and Locally locked for JP." (refer section Routing Comments Log and Case Print) followed by the configured comments under Argus Console ' Reporting ' Expedited screen' Forced Distribution comments.

i. Case Globally and Locally locked for JP. << Forced Distribution comments>>

c. After the report generation is complete, the case gets unlocked globally. AG Service uses the one step global/local unlock comment "Case Globally and Locally unlocked for JP." (refer section Routing Comments Log and Case Print) followed by the configured comments under Argus Console ' Reporting ' Expedited screen' Forced Distribution comments.

i. Case Globally and Locally unlocked for JP. << Forced Distribution comments>>

6.5.7 What components are affected by the expedited reporting rules algorithm?

The expedited reporting rules algorithm affects the following:

- Suppression of duplicate reports

- Blinded/forced distribution

6.5.7.1 Suppression of duplicate reports

You can suppress duplicate expedited reports to be scheduled at the reporting destination level, according to the following criteria:

- The Suppress Duplicate Reports option only applies to drug reports. It does not apply to device reports.

- This option does not reduce the number of reporting rules the system evaluates. However, it does prevent the system from scheduling and generating expedited reports that match the duplication criteria.

- When you select Suppress Duplicate Reports, the system uses the following attributes to determine whether the reports are duplicates of other reports:

- Report Form

- Reporting Destination

- Aware Date

- If two or more duplicate reports have different due dates (regardless of license type), the system schedules the report with the earliest due date.

6.5.7.2 Blinded/forced distribution

The system enables you to configure the Blinding Study option for products in the case.

- When you check this checkbox, the system blinds the study products for the report being sent to the reporting destination in a manner similar to the Bulk Reporting dialog box option.

- If you select either of the Blind Study product options (Reporting Rules or Bulk Reporting), the system blinds the study product information on the report form.

- The system blinds only active blinded studies. It does not blind the following case reports even if the Blind Study product is selected

- Open Label Studies

- Study is eligible for unblinding - If the Study is Unblinding checkbox is not kept as unchecked in study configuration, the user will be able to see the complete case data even if he/she has protection enabled.

- In cases where expedited reports are due, the system permits the user to force-distribute the reports based on user-defined reporting rules, even if case processing is incomplete.

- When you select the Force Distribution rule, the following occurs:

- If a case encounters a rule where a report is due is locked, the system schedules the report based on the rule and does the following:

- Generates the report on the due date.

- Dynamically replaces the current case comment with the force distribution case comment.

- Transmits the report based on the preferences defined by the reporting destinations.

- Displays the status in the Worklist Bulk Transmit/Transmit ICSR dialog boxs.

- The AG Service Force Reporting process for expedited reports completes the process by:

- Checking the reports required for force distribution

- Locks the case (if it's not already locked)

- Generates the reports and makes sure it is ready for transmission

- The notes for the Case Locking/Unlocking are the same as those defined as the common profile value for the Forces Distribution option; System is the user.

6.5.8 When are follow-up reports created?

Follow-up reports are created depending on the following parameters:

- Data for a case changes.

- Update information for a case has been entered by entering follow-up information in the General Information section of the General tab.

- Depending on the configuration set up by the Administrator, the system analyzes the scheduled reports prior to the data changes to see if they are still required.

- If the system determines that they are not required, the report status is marked as Downgrade. New reports are automatically scheduled, if required.

- If the system determines the report is still needed and needs to be updated, one of two functions can take place depending on the configuration done by the Administrator:

- The system overwrites the report

- The system schedules a new report in addition to the old report

- If the system has been configured to overwrite the existing report, the report status becomes New Data Available.

- In the Worklist, the status for this report shows New Data Available for this report. When you re-generate the report, you can select whether or not you would like to re-generate the report with the new data.

- If the system is configured to create a Follow-up report, the previous report remains in its current state and a new report is scheduled with the status of Scheduled.

- If a report has been previously submitted, this report is never deleted under any configuration.

6.5.9 When are the amendments created?

If the initial or follow-up E2B(R3) reports are submitted to a Reporting Destination or Agency, and the agency requests to send attachments, create the amendments by unlocking the case as significant follow-up and check the Amendment check box in the Case Form > General Tab > Follow-up section. Besides, enter the reason as well to create the amendments.

You can include attachments and provide details of the attachments in the Case Summary.

Amendment reports are auto-scheduled for the cases with Significant Amendments only, where the reporting destination is configured with an E2B(R3) profile.

Follow-up reports are auto-scheduled for the cases with Significant Amendments, where the reporting destination is configured other than E2B and E2B(R2) reports.

To manually schedule the Amendment reports for E2B(R3) for Significant Amendments or Non Significant Amendments, use the Scheduling New Expedited Report dialog. Select the Aware date pertaining to the amendment and schedule an E2B(R3) report. Aware date pertaining to an amendment can be identified by text (A) appended to the Aware date.

Note:
Oracle recommends that you have only one amendment for an Aware date, else it may be difficult to identify the latest amendment from the Aware date drop-down in the Scheduling New Expedited Report dialog.

When you manually schedule a report other than E2B or E2B(R2) for an Amendment Aware date, then the follow-up report is scheduled if there is a previously submitted report of the same report type to the same agency, else an initial report is scheduled.

Note:
You can create amendments only when a previously submitted E2B(R3) report exists.

6.5.10 Why can't I view a draft report?

You can only view a Draft report if the relevant case is unlocked.

6.5.11 Why doesn't my draft report print a follow-up number?

The following expedited report forms do not print a Follow-up number when the user selects DRAFT on the Regulatory Reports tab or when he/she selects the Quick Launch Draft option:

- US FDA MedWatch Drug/Device

- US FDA VAERS

- CIOMS I/CIOMS I (Local)

- French CERFA

- Spanish Spontaneous/Clinical

6.5.12 How does the Lock State Column under Reports > Compliance > Expedited allow me to sort my cases?

Click the Lock State header row to sort on the following category of cases. A pop-up window appears, with the following sorting options:

- Lock State

- SUSAR

- Exp/Per

Click the required option to sort cases based on the selected case categorization.

Lock icons

Icon...

Identifies...

A case marked for a Periodic ICSR submission.

A locked case.

An unlocked case

A SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

Lock icon options

Field

Description

Report Details

Displays specific information about the report as entered in the Regulatory Reports section.
The information displayed in the fields of the Report Details dialog box is fetched from the data entered in the Regulatory Reports section of Case Form.

6.5.13 How do I view the status of my Expedited Report?

To..

Do..

View the regulatory reports for a particular case (scheduled, generated and submitted)

Open the Regulatory Reports tab of the Case Form.

View all scheduled, generated, and approved reports, as well as other outstanding action items

Select Reports from the Worklist menu.

View a list of all scheduled, generated, and approved reports

Select Compliance | Expedited from the Reports menu.

View all the submitted reports in the system

Select Compliance |Submitted from the Reports menu.

6.5.14 How do I know if an unscheduled report is due soon or needs to be submitted?

As report scheduling is commonly configured to be executed when significant changes are made to a case, the expedited reports may be delayed if a case never gets locked. You cannot know that a report is late if it has never been scheduled. To address this potential compliance issue Argus Safety assesses case reportability prior to formal report scheduling. Workflow and Expedited Status monitoring screens identify unlocked cases due soon.

- To view a list of unlocked cases with reports due, select Dashboards, and then click Reports Due Soon.
The Unlocked Cases with Possible Reports Due Soon screen appears.

- The Workflow and Expedited status include another report with cases that have not had reports scheduled but that may generate a report with a due date in the near future. This graph is displayed below the graph detailing the actual case status. The reports included in this sub-dashboard are limited to the filter criteria specified for the main dashboard.
To view a Worklist with cases of the selected state (red or yellow), click the graphical bar.

6.5.15 Where can I view single reports which have been generated as part of a periodic report?

The Periodic folder contains single case report forms (MedWatch, VAERS or CIOMS) that were generated as part of a Periodic Report.

- Pending Reports by Destination

- Submitted Reports by Destination

- Non-submitted Reports by Destination

7 Manage your periodic report submissions

Periodic reporting plays a key role in the safety assessment of drugs. It involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. The advantage of Periodic reporting is that it provides a broader view of the safety profile of a drug.

7.1 Prepare content for periodic reports

7.1.1 Prepare your aggregate reports

These reports are executed in the background through the AG Services. A new Argus service named Batch Aggregate Report Generation is available for this purpose.

7.1.1.1 Understand aggregate reports

- The date and time printed on the following reports are the date and time the query is executed for case qualification. They are not the date/time the query was completed and the report obtained Web Server.

- Case Listing Report

- Case Data Analysis Report

- The system converts the following elements that display in the case form as actual text on the Case Listing and CIOMS II Line Listing reports:

- Duration of Administration

- Time Between First Dose/Primary Event

- Time between Last Dose/Primary Event

- Capture the report follow up number in the Regulatory Reports section. The system prints the report follow-up number on the expedited reports in the following format:
F/U# X

where:

X is the report follow-up number.

- For an initial report, the system prints initial in the column.

- If there are no reports for the case in the Case Listing/CIOMS II Line Listing, the column is left blank.

- This option is available on the CIOMS II Line Listing/Case Listing reports.

- The system uses the IE offset of the client workstation to print the date and time component for all system-calculated fields on the Case Listing/CIOMS II Line Listing reports.

- You can filter cases in the following aggregate reports based on the lock/archived date.

- When you select Case Locked/Archived date, the system limits the cases based on whether the case is locked/archived within the specified time frame.

- The lock date is considered the locked date.

- If you select the Case Patient or Reporter Information in the Case Listing or CIOMS II Line Listing reports and the Protect Confidentiality field is checked for the patient or reporter Information, the system does not print the relevant patient or reporter Information selected in the Case Listing or CIOMS II Line Listing report.

- If you do not have permission to view the reporter or patient information, the corresponding reporter or patient elements selected on the Case Listing or CIOMS II Line Listing report are blank.

7.1.1.2 View saved aggregate reports

The System Reports Library displays the list of the saved aggregate reports including Case Data Analysis, Case Listing and CIOMS II Line listing reports. This screen displays only the reports either created by the logged in user or the reports that are shared for your user group during report creation.

- The Aggregate report supports only PDF or CSV formats.

- The system report library screen, provides the way to filter the reports through:

- Report Name

- Description

- Report Type

- Output Type

- Author

- Last Modified

- Available for Periodic

- Shared

- The reports can be executed through the Print option. When you click Print, the applications opens the Report Batch Printing dialog box, where you can run or schedule the report for the desired format (PDF/CSV). You can send an email for the completion status.

- The open option allows to open and edit the memorized reports.

- If the user clicks Transmit, the system generates the selected report and starts the transmit process. The system displays the Recipient pop-up.

Note:
A shared report can only be deleted by the Administrator or the user who created it.

7.1.1.3 Create a Case Data Analysis report

The Case Data Analysis Report enables you to view quantities of cases over time in a Cross-Tabular Fashion.

1. Select Reports, then select Aggregate Reports, and click Case Data Analysis.

2. In the Case Data Analysis Report view, select the information that must appear in the report.

3. In Row1, select the field the system uses to group cases by row.

4. In Column1, select the data the system uses to group cases by column.

5. In Row2, select the field by which each Row1 item will be categorized.

6. In Column2, select the field by which each Column1 item will be categorized.

7. Select a product family to which the report applies, if appropriate.

8. In Selection for Row1, select the value for row 1 by which the report must be restricted.

9. Specify an advanced condition, as appropriate.

10. Select Report Number of Cases or Report Number of Events, depending on the number of cases or the number of events to be entered in the report.

11. If you select Report Number of Events, you can specify the kind of events (serious listed, non-serious listed, serious non-listed, or non- serious non-listed) that will appear in the report.

12. Select whether only the top few items should be displayed and enter the number of items that should be displayed.

13. Check the Show% of Total checkbox to specify the percentage in each cell in the report.

14. Check the Blinded checkbox to hide blinded information in the report. This field is unchecked and disabled for a restricted user.

15. Check the Use Case Search Results checkbox to limit the Case Data Analysis only to the cases present in the Case Search dialog box.

16. Specify a date range for the cases that will appear in the report.

17. Enter a title for the report.

18. Click the Share this report with other users if there is a need to share the report/report output to other users. Note that the report may contain sensitive data. By default, the report is shared with all users. You can restrict it through Group, where the allowed user groups can be selected. When a report is shared for a user group, only members of that group and the report creator can access the report further.

19. The report can be used in the periodic report using Make available for use in Periodic Reports.

20. The Case Data Analysis report, in addition to the PDF and CSV format, supports the chart format too.
This report output can be selected via Report Display Type field. The following chart types are available:

- Bar Graph

- Line Chart

- Area

- Pie

- Donut

- Stacked

Note:
The chart reports are run in sync and available only the user's browser and not stored in the database.

21. Click Print to execute the report in background. This report can later be viewed under system reports library.

22. The memorize button saves the report in the application. It does not execute the report.

7.1.1.4 Create a CIOMS II Line Listing report

The CIOMS II line listing report is a common format desired by Drug Safety professionals for reviewing cases. Create this report from the CIOMS II Line Listing dialog box.

1. Select Reports, then select Aggregate Reports, and click CIOMS II Line Listing.

2. On the CIOMS II Line Listing Criteria tab, select information for the header, footer, product family, advanced condition (if any), cases to include, and date.

3. Select either the Case Creation Date or Case Receipt Date radio button and specify a date range to run the report.

Note:
If you perform a search and return a list of cases to the Case Search screen, the Use Case Search Results is visible. Checking this box will disable all selection criteria with the exception of Include Unlocked Cases. For example, the Advanced Condition and Date Range will be disabled.

4. In the Line Listing tab, add or remove the appropriate fields.

5. In the Grouping tab, add or remove elements, insert a page break and change the sort order (if desired).

6. Click Memorize to open the Memorized Report dialog box.
The Memorize button saves the report in the application. It does not execute the report.

7. Click Print to execute the report in background. This report can later be viewed under system reports library.

8. This report can be shared with other users of Argus and the sharing can be restricted through the User Group selection.

7.1.1.5 Create a case listing report

The Case Listing Report enables you to filter cases based on Case Initial Receipt Date and Case Creation Date. You can select multiple entities from the List of available fields using the CTRL+CLICK functionality.

1. Select Reports, then select Aggregate Reports, and click Case Listing.

2. When the system opens the in the Case Listing Reports view select the information to appear on the report.

3. Select the fields that are to appear in the report from the Available Fields list.

4. Click Add. Repeat this process for each field that must appear in the report.

5. Use Move Up and Move Down to arrange the fields in the Selected Fields list.

6. Check the Blinded checkbox to hide blinded information in the report.

7. Specify an Advanced Condition, if appropriate.

8. Specify a date range for the cases to be displayed in the report.

9. If you check the Include in Header checkbox, the selected date range is displayed on the report.

10. Under Sorting Order, select the fields by which the cases will be sorted. You cannot sort the cases by fields that do not appear on the report.

11. Enter the title of the report.

12. Click Memorize to memorize the criteria specified for a particular report.
The Memorized Report dialog box appears.

13. Save, Delete or Cancel the report, as applicable.

14. Click OK in the Case Listing Reports screen to generate the report. The report will be generated in PDF format.

7.1.1.6 Check aggregate report execution status

Go to Reports, then select Compliance, and click Report Generation Status.

This screen displays the status of report generation for both Periodic and Aggregate reports. The Aggregate Reports can be filtered using the report type filter.

7.1.2 Periodic report types

On the Reports menu, hover over the Periodic Reports option, to go to any of the Periodic Reports.

You can create the following periodic reports:

- Clinical Trial Periodic Reports

- ICH PSUR Reports

- US IND Periodic Reports

- US NDA Periodic Reports

7.1.2.1 Store periodic reports in Documentum

When you approve an expedited report from within Argus, the system exports the report as a PDF file and saves it in the Documentum database by Argus Safety Service. From this point, you can perform document reviews within the Documentum system.

When the report is ready to be submitted, mark the report as Submitted from within Argus. Argus Safety Service updates the status of the report within Documentum to Submitted.

If the report is to be transmitted via fax or email, Argus Safety Service marks the report as a successful submission in Documentum only after the fax or email transmission has succeeded.

7.1.2.2 View a summary of periodic regulatory reports

You can select any of the following options in viewing the summary of a periodic regulatory report:

- To view the regulatory reports for a particular case (scheduled, generated, and submitted), open the Regulatory Reports tab of the Case Form.

- To view all scheduled, generated, and approved reports, as well as other outstanding action items assigned to you or your user group, select Reports in the Worklist menu.

- To view a list of all scheduled, generated, and approved periodic reports, select Periodic Reports from the Reports | Compliance menu.

7.1.2.3 Use the library page

The Periodic report has a library page from where you can create a new report, execute an already created report, view the output and so on.

- PSUR (legacy PBRER, PSUR and Flexible PBRER, PMAR reports)

- CTPR (legacy CTPR and Flexible DSUR reports)
All fields that are used by the Flexible DSUR is highlighted with blue BIP icon.

- IND

- NDA

While a report is running, it can be modified or run again until the previous run is complete.

7.1.3 Prepare content for a Clinical Trial Periodic Report

The Clinical Trial Periodic Reports (CTPR) are created to report the IND Annual reports and EU Clinical Trial Directive line listing reports to FDA.

7.1.3.1 Create a Clinical Trial Periodic Report

1. Select Reports, then select Periodic, and click CTPR (Clinical Trial Periodic Reports) to open a list of CTPR Reports.

2. To create a new report from an existing report in the list, click Copy or Modify.

3. Click New Report to create an entirely new report. The Clinical Trial Periodic Reports pop-up window opens.

4. Enter an appropriate name for the report under Report Name.

5. Use the tabs in this pop-up window to configure the CTPR.

7.1.3.2 Enter common fields information

The Report Name, Report Category and Report Sub-Category fields are common to all tabs of the Reports.

Field

Description

Report Name

Enter a name for the Report. The name entered here is displayed in the Reports menu.

Report Category

1. Select a category for the Report. This is displayed in the Reports menu.

2. Select New to define a subcategory within the report category.
The Periodic Report Category dialog box is displayed.

3. Enter a category name in Category and click OK.

4. The category is entered in the Report Category drop-down list.

Report Sub Category

1. Select a subcategory for the report.

2. Select New to define a subcategory within the report sub-category.
The Periodic Report Category dialog box is displayed.

3. Enter a category name in Category and click OK.

4. The category is entered in the Report Sub-Category drop-down list.

7.1.3.3 Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency, products, etc. for which the CTPR is applicable.

Field

Description

Available Reporting Destination

Displays the list of configured Regulatory Agencies. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.

Likewise, select an agency from the Selected Destination list and click Remove to remove it from the selected destination.

Primary Agency

Select the primary agency for the report.
When you submit a Periodic report, it goes to the selected Primary Agency.

Selected Reporting Destination

Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.

Likewise, select an agency from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.

Ingredient

Automatically displays the Ingredient as provided in the Subject of Report dialog box.
You can choose whether to view this field or not. Click the checkbox displayed with this field to hide or view it.

Trade Name

Automatically displays the Trade Name(s). Multiple trade names are also displayed together, separated by commas.
You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.

International Birth Date

Automatically displays the earliest license awarded date, when a user selects an Ingredient and a Product.
You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.

Print all configuration criteria on separate cover page

Mark this box to print out the configuration of this report when the report is printed. This is only available when PDF option is selected during printing.

Print page numbers on reports

When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.

- The Include Periodic Page Numbering option in the CTPR Summary Tabulations CIOMS Report section is inactive and grayed out.

- The User Periodic Numbering on the report option on CTPR Summary Tabulations FDA CTPR support section is grayed out and inactive.

- The Additional Separate Page Numbering for UD Summaries option on the CTPR UD Summaries tab is grayed out and inactive.

- The system removes all existing report page numbering and the option to check page number checkboxes on the report configuration tabs are grayed out and inactive.

Allow access to report cases through Case Series

When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List.

7.1.3.4 Select products to include in CTPR

The Product Selection tab enables you to select the products included in the CTPR report.

Field

Description

Available Ingredients

Displays the list containing the Ingredients used for the product configuration. Select an ingredient from the list displayed in Available Ingredients and click Add/Remove to add/remove the ingredient.
You can select multiple ingredients at a time.

Filter

Enter an Ingredient name and click Filter to search for the entered ingredient within the Available list of Ingredients.

Selected Ingredients

Displays the list of ingredients selected from the Available Ingredients list.

Available Countries

This list is auto-populated and displays only the countries with a license containing the ingredient selected from the Available Ingredients list.

Selected Countries

Displays the countries selected from the Available Countries list.

Indication

This list contains the Indication configured for the product containing the ingredients in the Available Ingredients section. The selections made from this list get displayed in the Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL key and clicking the different Indication entities.

Formulation

This list contains the Formulation configured for the product containing the ingredients in the Available Ingredients section. The selections made from this list get displayed in the Selected Products section.
You can select multiple Formulations from the list at a time by pressing the CTRL key and clicking the different Indication entities.

7.1.3.5 Configure license or study in the report header

The License/Study tab is used to configure the report header and to specify the agency, products, etc. for which the CTPR will be applicable.

Field

Description

Available Licenses

Contains licenses that use the ingredient selected in the Ingredient field. This field is automatically populated when an ingredient has been selected.

Selected Licenses

Displays the licenses selected from the Available Licenses list by clicking Add/Add All. You can select Licenses that are related to different ingredients for a report.

Available Studies

Contains studies that use the ingredient selected in the Ingredient field. This field is automatically populated when an ingredient has been selected.

Selected Studies

Displays the studies selected in the Available Studies list by clicking Add/Add All. You can select studies that are related to different ingredients for a report.

7.1.3.6 Select inclusion criteria

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a periodic report.

The top section of the dialog box allows you to specify the type of cases that will be included in the periodic report.

Field

Description

Case Creation Date

Allows you to specify a range of cases by the date when the case was created.

Case Receipt Date

Allows you to specify a range of cases by the initial receipt date.
Note: The Date Range is only available when an unscheduled CTPR is being created. You must specify only one date range out of Case Creation Date and Case Receipt Date.

Case Locked/Archived Date

Allows you to specify the date when the case was locked/archived.

Use Current Version

Allows you to use the latest revision to populate the data within the selected reports.

Use DLP Version

Allows you to use the case data of the version as of the specified DLP Version.

Age Groups

Allows you to include or exclude cases based on the patient's age group. Select all the age group categories that apply.

Restrict Cases to countries where studies are active

References study configuration to determine if the case was submitted during the dates the study was active.
Note: This option is available only if a study is selected from the Available Studies section in the License/Study tab.

It should not be used for Centrally approved products (CAP), which only have an EU license.

Advanced Condition

Allows you to specify an advanced condition that must be satisfied by each case that is included in the report. Ensure that the advanced condition or the advanced condition query set that is specified here does not contradict any other criteria specified in the dialog box.

Datasheet for Listedness

Select the Datasheet to look against for Listedness when running the report.
Note: Select the ALL datasheet to use the most conservative listedness for the primary event, or the Case Listedness for the tabulation.

Use Assessment in Cases

When selected, the CTPR Report will use the Case Event Assessment when performing datasheet listedness calculations.

Re-assess cases against datasheet in effect at the beginning

When selected, the CTPR will re-assess the cases in the line listing based on the Active Datasheet on or before the Start Date of the Reporting period.

Re-assess cases against datasheet in effect at end

When selected, the CTPR will re-assess the case in the line listing based on the Active Datasheets on or closest to the end date of the CTPR Reporting end date range without exceeding that date.

Reference Type (Clinical Reference Data Element)

Select the reference type to be displayed on the Main Listing if Clinical Study Reference is selected as a Data Element in the Available Data Elements section of the Line Listing tab.

Expeditable Only

This option is enabled only when an agency has been specified on the Subject of Report tab. Check this option to include only those cases that have submitted expedited reports to the specified Primary Agency.

Exclude Follow-up cases

Follow-up cases are cases with a significant follow-up in the Clinical Trial reporting period where the initial receipt date is in a prior period. Check this option to exclude follow-up cases from appearing on the Clinical Trial report.

Include Unlocked Cases

Check this option to allow cases that have not been locked for reporting to appear on the report.

Use Datasheet Assessment for UDF Tabulations

Allows you to select datasheet for a report to make UDF tabulations. If no datasheet is selected, the most conservative listedness is chosen, such as Unlisted followed by Listed.

Add Cases not included in previous reporting period

Allows you to add cases which were not included in the previous reporting period.
You can enter the start date of the period in the Start Date field.

7.1.3.7 Use the Data Lock Point (DLP) version

DLP primarily uses two processes:

- Last Completed Version - This option always uses the case version with the last lock that existed prior to the DLP or As of Reporting date. This option does not enable data cleaning
DLP saves only the last revision when multiple saves are performed in the same job session.

- Next Completed Version - This option uses the current case lock or the next following case lock if the case version was initiated prior to the DLP or the As of Reporting date with two exceptions:

- If there is no case lock for the current version that was received prior to the DLP, the last (current) case revision is used.

- If there is a case version after the case lock that was created for the purpose of data cleaning, it is to be used instead of the first locked case revision.

- If there are multiple contiguous case versions following the first case lock for the purpose of data cleaning, the last case data cleaning version is used.

Note:
The Data Cleaning option is available only with the DLP option Use Next Completed Version (Includes Data Cleaning).

7.1.3.8 Use DLP queries for dates

You can perform DLP queries for the following:

- Receipt Date -- date entered by the user during case creation

- Initial/Follow up Receipt Date

- Safety/Safety Follow up Receipt Date

- System Date (Case Creation Date) - date the case was physically entered

7.1.3.9 Use As of Reporting function

The As of Reporting function returns the same case version results as the DLP Options, with the only difference that the date depends on the As of date instead of a DLP date.

7.1.3.10 Find DLP and As of Query functionality

The DLP and As of Query functionality is available in the following application modules:

- Periodic Reports

- PSUR including all User defined Tabulations and expedited reports within the Periodic Report

- CTPR including all User defined Tabulations and expedited reports within the Periodic Report

- IND including all User defined Tabulations

- NDA including all User defined Tabulations and expedited reports within the Periodic Report

- System Reports

- CIOMS II Line Listing

- CDA Reports

- Case Listing Reports

7.1.3.11 Include line listing

Field

Description

Include Line Listing

Allows you to select whether you want the Line Listing Data Elements printed with the CTPR Report.

Blind Line Listing and Summary Tabulations

Hides the selected listings from being displayed

7.1.3.12 Add data elements

Select the checkbox associated with a data element (field) to add that field to the report.

- By default, the system print s unavailable fields on the report, and they cannot be changed.

- Required data elements are printed as columns in the report. The optional data elements are printed as separate rows below the column data for each case.

7.1.3.13 View selected data elements

This section lists the selected elements and enables you to arrange the order in which these are to be printed. Click the Up or Down buttons to arrange the listed elements above or below in order of priority.

Field

Description

MedDRA Hierarchy from Cases/Dictionary

Select Cases to populate the data from the case data. Select Dictionary to populate the data from the MedDRA dictionary.

Print Only the Term (Preferred Term or Lower Level Term)

Prints only the event Preferred Term (PT) or event Lower Level Term (LLT) as per the selected radio button. Select the PT option to print only the preferred term and not the verbatim description.

Print Dose Text in place of regimen dose

Prints the dosage and frequency information from Dose Description field instead of Regimen Dose.

Indicate if case was expedited previously

This checkbox is selected if a primary agency has been selected in the Subject of Report tab. Cases for which an expedited report was previously submitted to the selected authority are marked with an asterisk.

Local Language

Allows a user to specify which Local language for a multi-language field is to be printed. Namely, the Abbreviated Narrative field.

Print event info (Serious, Un-listed, Related) as Column

Select this checkbox to print the Seriousness, Listedness and Causality under the Event Verbatim column.
Note: Events having listedness of Unknown are considered Unlisted. If only diagnoses are assessed for event assessment, the events which are associated with a Diagnosis but have been marked with Diagnosis as Np display - for both listedness and causality.

List cases only once, under the primary event

Select this option to view the details of cases in the Main Line Listing only once under the Primary Event

List cases under all events, details under the primary event

Select this option to view the details of cases in the Main Line Listing only once under the Primary Event, while non-primary events are listed under their respective event hierarchy with a reference to the primary event body system. Therefore, use this option when grouping on Main Line Listing is by the Event Body System.

Print Product Indication for the product selected in the report

Select this option to print Product Indication for the product selected in the report.

7.1.3.14 Group cases

Field

Description

Available Groupings

Allows a user to group cases together from the given list. Select the desired groupings from the list and click Add to move the grouping to the Selected Groupings list. Up to 10 grouping options can be selected.

Selected Groupings

Lists the added groupings made available from the Available Groupings list, and reports the groups in the order they were selected.

Ascending

Select this checkbox to sort the selected entities in ascending order.

Page Break

Select this checkbox to start the cases from a new page, while also keeping the sorting together for every selected page break.

Available Sortings

Allows a user to sort cases together from the given list. Select the desired sortings from the list and click Add to move the sorting to the Selected Sortings list.

Selected Sortings

Allows a user to further sort cases without a total count for each sorted item. Up to 3 levels of sorting can be selected from the Available Sortings list.

7.1.3.15 Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations/Listings will appear along with the line listing.

Field

Description

Include Index of Cases in CTPR

Create an index page of case numbers, for all cases included in the CTPR.

Include Summary of Cases Missing Assessments

This option creates a sub-report of cases missing one of the following items:

- Seriousness

- Case Causality

- Case Listedness

- Case Outcome

- Event Causality

- Event Listedness

Click this checkbox to create one or both of the following sub reports:

Cases Missing Assessments - This sub-report displays cases that have been included in the CTPR line listing, but one or more of the following have not been assessed:

- Case Seriousness

- Case Causality

- Case Listedness

- Case Outcome

- Event Causality

- Event Listedness

Cases Not Included in Report - This sub-report displays cases that have not been included in the CTPR line listing as a result of missing one or more of the following items:

- Lock Status

- Safety Date

- Uncoded Event

- Causality

Count of Cases per Report Type

This option prints a Sub Report that counts the number of cases versus the Report Type, based on the cases within the CTPR.
The Cases per Report Type can be either of the following:

Count Cases with Initial Expedited Reports: Counts cases with initial Expedited report.

Count of cases with Follow-up Expedited report: Counts cases with Follow-up Expedited report.

Total Count of Initial Cases in the Report: Counts any (serious - non-serious) cases received during the reporting period.

Total Count of Follow-up Cases in the Report: Counts any (serious - non-serious) follow-up cases entered during the reporting period.

Cumulative Count: Count of cases received from the start of the trial.

Event Count per Study Drug

Creates a sub-report with Event count per Study Drug based on the selected causality. 2 configurations are possible as to allow for a count of related events vs. non-related events.

All Study Drugs in Single table

Suppresses 0 current columns (with their cumulative) and print everything in a single cross tab.

Grouped by Study Drug

Prints a cross tab report for every product. Prints the cumulative totals even if the current period has no events.

Event Type to Include

Prints SUSAR events on the CTPR Report based on the option selected from the drop-down list:

- Separate counts of SUSAR and non-SUSAR events
Prints SUSAR and non-SUSAR events listed separately. SUSAR events are marked with an asterisk

- Combined count of SUSAR and non-SUSAR event
Prints SUSARs. Normal events are grouped into one (current functionality)

- Only count SUSAR events
Prints Only SUSARs. Namely, non-SUSARs would not be printed.

Include Line Listing Tabulation

Select this checkbox to view a pre-defined summary tabulation of Report type, Seriousness and Listedness of all cases in the CTPR.

Include Initial Cases

Select this checkbox to include initial cases in the CTPR tabulation.

Additional Expedited Report Forms (CIOMS/MedWatch/VAERS)

Allows you to print CIOMS/MedWatch/AERS forms (as per selection) for its respective regulatory agency (as selection), for all cases in the report. It also provides an option to have (or not have) a watermark in the forms.

CIOMS reports—fields descriptions

Field

Description

Print CIOMS reports for serious/unlisted cases

Allows a user to print CIOMS I forms for all Serious/Unlisted (Case Level) cases appearing in the CTPR.
CIOMS contain Internal or Other text printed on them when the CTPR is printed using the Internal or Other option.

Include Periodic Numbering on the CIOMS reports

Numbers the requested CIOMS I with a periodic format. (Namely, A-1-1 of 2, A-1-2 of 2, A-2-1 of 1, A-3-1 of 1 etc.). The index is modified to also contain the Periodic paging of each CIOMS report.

Cumulative summary—fields descriptions

Field

Description

Include Cumulative Summary

Select the checkbox to create a sub-report count of events, grouped by Product and Body System (SOC) and sorted by Preferred Term. The sub-report contains a previous date range count of events (comparative date range), a current date range count (current CTPR date range) and a cumulative count (all dates) of events assessed against the product(s) of the CTPR and matching the inclusion criteria.

Comparative Date Range

Allows a user to specify the previous date range as a comparison date for the events counted, and therefore should not overlap with the current date range specified on the CTPR inclusion criteria tab.

FDA CTPR support—fields descriptions

Field

Description

FDA CTPR Support Section

Include Adverse Event Summary

Select this option to generate a sub-report of events from the line listing. This sub report is grouped by Body System and Preferred Term.
Note: This section can be used if the company has obtained an FDA waiver to submit a CTPR instead of an NDA report.

Causality

Select the desired causality from the list.
Ignore - Counts events regardless of causality assessment.

Causal - Counts events where the causality is considered reportable in the Causality Category configuration in List Maintenance.

Not Causal - Counts events where the causality is considered non-reportable in the Causality Category configuration in List Maintenance.

As Determined - Counts events where As Determined causality meets the above selected causality criteria.

As Reported - Counts events where As Reported causality meets the above selected causality criteria.

Both - Counts events where both As Reported and As Determined causality meet the above causality criteria.

Either - Counts events where either the As Reported or As Determined causality meets the causality criteria.

Only Cases with HCP Reporter

Select this checkbox to include events for only those cases that feature an HCP reporter

Diagnosis

Select this radio button to ensure that only events marked as diagnosis are counted.

Diagnosis & Symptoms

Select this option to ensure that all events are counted in the sub-report.

Separate Diagnosis & Symptoms

Select this option to include all SUSAR events in the CTR Report.

Print Unsubmitted

This option allows a user to print MedWatch or VAERS forms for U.S. cases. The following types of cases will be excluded:

- Foreign Cases (Country of Incidence not equal to U.S.)

- Clinical Trial Cases (Case Report type in list maintenance has this type includes cases from clinical trials checked.)

- Literature Cases (Case Report type in list maintenance has this type include case from literature checked.)

- Cases with submitted expedited reports to the Agency selected in the CTPR.

Exclude Reports that are Non-Serious and Listed

Allows a user to suppress MedWatch or VAERS forms from printing for Non-Serious listed cases where all events are non-serious and listed for the datasheet specified.

Use Periodic numbering on the Reports

Numbers the requested forms with a periodic format. (Namely, Periodic Page 1 - 1, Periodic Page 1 - 2, Periodic Page 2 - 1, Periodic Page 2 - 2, etc.) An index with the Case Number is also included.

7.1.3.16 Generate single case submission report

Field

Description

Single Case Submission Support Section

Generate Periodic ICSR Submissions for any cases in this Periodic Report that does not have at least one scheduled single-case report during the reporting period to the following Reporting Destination(s): Modify

Select this checkbox to generate the ICSR Reports only for the cases, where a Periodic ICSR Report for the message type chosen, does not exist.
Select one or more trading partners from the list box.

Important: Any case that does not have an expedited or single case periodic submission to a trading partner, must have an ICSR report scheduled as a part of the Periodic submission.

Click Modify to select a different Reporting Destination.

Schedule these single-case Periodic Reports to the following Reporting Destination

Select a single-destination trading partner for Periodic Reports from the drop-down list box.

Using the Message Type

Select the required message type from the drop-down list box

7.1.3.17 Select summary listing

The UD Summaries tab allows you to specify which summary listings will appear along with the line listing.

Field

Description

Include these summary tabulations/listings based on the set of cases presented in the line listing

Allows you to select from pre-configured summary tabulations/listings based on Case Data Analysis, Case listing or CIOMS II line listing reports. These tabulations are based only on the data included in the line listing. Select the Exclude Follow-up Cases checkbox to filter out follow-up cases from the attached report.
If the Exclude Follow-up Cases option is selected on the Inclusion criteria tab, this option is ignored and follow-up cases are always filtered out.

Include these summary tabulations based on all cases

Allows for additional sub-reports based on the 'Case Data Analysis' template, to be included as an output for the all cases in the database that meet the CTPR inclusion criterion for all dates.

Include these summary tabulations/listings based on the Date Range

This option allows for additional sub-reports based on Case Data Analysis, Case listing or CIOMS II line listing reports to be included as an output for the cases meeting the CTPR inclusion criterion for the Date Range specified when adding the sub-report.
The dates are based on either the Case Creation Date or the Initial Receipt Date as entered on the CTPR Inclusion Criteria tab. Check the checkbox to the right of the sub-report to ignore considering follow-up cases for the sub-report.

7.1.3.18 Schedule the report

The Scheduling tab enables you to specify details of how often the periodic report will be scheduled.

Field

Description

Start Date

This is the International Birth Date for the PSUR product. This date is computed as the earliest Awarded date for any license of any type.

Recalculate

Allows a user to recompute the International Birth Date of the PSUR Product. This date can be overwritten/manually entered, if needed.

Report is due xx days after selected end date (creation or receipt date)

Enter the number of days when the report will be due after the end date specified for the scheduling period.

Automatically generate report xx days before/after selected end date at xx:xx

Allows a user to specify the timing of the automatic report generation, by specifying the number of days before/after the selected end date of the report.

Group

Allows the user to select the group to which the automatically generated report is to be assigned

7.1.3.19 Setup frequency of the scheduled reports

Field

Description

Frequency

Allows a user to specify the interval required for this scheduling period.

7.1.3.20 Configure security level of the report

The Security tab is used to configure the security level for the PSUR.

Field

Description

Share this Report with Other Users

Click this checkbox to share this report with other users. Specify the privileges to be granted to groups by adding the group name from the Users Groups list to either the Execute or Modify and Execute list. A user group can exist in only one of these access lists.

User Groups

The groups listed here have no access to the PSUR report template. Click Add or Remove to move them to another access list.

Execute

The groups listed here have read and execute access to the shared PSUR report template.

Modify & Execute

The groups listed here have read, execute and modify access to the shared PSUR report template.

7.1.3.20.1 Use report templates

Refer to the Oracle Argus Dossier User Guide for a description of fields in the Templates tab.

7.1.4 Prepare content for an ICH PSUR

The Periodic Safety Update Reports (PSURs) are created on a periodic basis to enable regulatory authorities to monitor the safety of a marketed product. This information is used to view new data about the product acquired from appropriate sources. It helps relate this data to the patient exposure and also indicates whether changes should be made to the product information in order to optimize the use of the product. Requirements on the due date of periodic reports may differ for different regulatory authorities.

7.1.4.1 Create Periodic Safety Update Reports (PSURs)

1. Select Reports, then select Periodic, and click ICH PSUR Reports. A list of PSUR Reports opens in the right frame.

2. Click Copy or Modify to create a new reports from an existing report.
OR

Click New Report to create an entirely new report.

3. When the system opens the ICH PSUR Line Listing Reports dialog box, enter an appropriate report name in the Report Name field.

4. Use the tabs to configure the PSUR.

7.1.4.2 Enter common fields information

See Enter common fields information

7.1.4.3 Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency, products, etc. for which the PSUR will be applicable.

Field

Description

Primary Agency

Select the Primary Agency.

Reporting Destination

Displays the list of agencies from where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
You can select multiple agencies from the list of agencies such that the report can be submitted to multiple agencies at the same time.

Likewise, select a report from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.

Selected Destination

Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
You can select multiple agencies from the list of agencies such that the report can be submitted to multiple agencies at the same time.

Likewise, select a report from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.

Ingredient

Automatically displays the Ingredient as provided in the Subject of Report dialog box.
You can choose whether to view these field or not. Check the checkbox displayed with this field to hide or view it.

Trade Name

Automatically displays the Trade Name(s) as provided in the Subject of Report dialog box. Multiple trade names are also displayed together, separated by commas.
You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.

International Birth Date

Automatically displays the earliest license awarded date, when a user selects an Ingredient and a Product.
You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.

Print all configuration criteria on separate cover page

Mark this box to print out the configuration of this report when the report is printed. This is only available when PDF option is selected during printing.

Print page numbers on reports

When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.

- The Include Periodic Page Numbering on CIOMS reports option on the PSUR Summary Tabulations CIOMS Reports section is grayed out and inactive.

- The Use Periodic Numbering on the reports option in PSUR Summary Tabulations FDA PSUR section is grayed out and inactive.

- The Additional Separate Page Numbering for UD Summaries in the PSUR UD Summaries tab is grayed out and inactive.

- The system removes all existing report page numbering and the option to check page number checkboxes on the report configuration tabs are grayed out and inactive.

Allow access to report cases through Hit List

When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List.

7.1.4.4 Select products to include in ICH PSUR

Field

Description

Available Ingredients

Displays the list containing the Ingredients used for the product configuration. Select an ingredient from the list displayed in Available Ingredients and click Add/Remove to add/remove the ingredient.
You can select multiple ingredients at a time.

Indication

This list contains the Indication configured for the product containing the ingredients in the Available Ingredients section. The selections made from this list get displayed in the Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL key and clicking the different Indication entities.

Formulation

This list contains the Formulation configured for the product containing the ingredients in the Available Ingredients section. The selections made from this list get displayed in the Selected Products section.
You can select multiple Indications from the list at a time by pressing the CTRL key and clicking the different Indication entities.

Available Products

This list is automatically populated with the selections made in the Indication section.

Selected Products

This list contains products selected by the user from the Available Products list. When a product is selected, the Trade Name field and International Birth Date fields are auto-populated with the license trade name (formulation, concentration) and earliest License Award Date for the product.

7.1.4.5 Select inclusion criteria

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a periodic report. The top section of the dialog box allows you to specify the type of cases that are to be included in the periodic report.

Click Add to add a criterion. Select appropriate items from the list of items that appear.

Field

Description

Use Assessments in Cases

When selected, the PSUR Report will use the Case Event Assessment when performing datasheet listedness calculations.

Re-assess cases against datasheet in effect at the beginning

When selected, the PSUR will re-assess the cases in the line listing based on the Active Datasheet on or before the Start Date of the Reporting period.

Re-assess cases against datasheet in effect at end

When selected, the PSUR will re-assess the case in the line listing based on the Active Datasheets on or closest to the end date of the PSUR Reporting end date range without exceeding that date.

Expeditable Only

This checkbox is available only when an agency is selected in the Subject of Report tab. If you check this checkbox, only the cases classified as submitted expedited reports to the specified agency are used.

Exclude Follow-up Cases

Filters out follow-up Reports from the PSUR Line Listing Report.

Include Unlocked Cases

Allows you to include unlocked cases in the periodic report.

Advanced Condition

Allows you to specify an advanced condition that must be satisfied by each case that is included in the report. Ensure that the advanced condition or the advanced condition query set that is specified here does not contradict any other criteria specified in the dialog box.

Use Datasheet Assessment for UDF Tabulations

Allows you to select datasheet for a report to make UDF tabulations.
If no datasheet is selected, the most conservative listedness is chosen. Namely, Unlisted followed by Listed.

Add Cases not included in previous reporting period

Allows you to add cases which were not included in the previous reporting period.
You can enter the start date of the period in the Start Date field.

Dropdown list

Select the appropriate report type from the drop-down list.

Datasheet

This list allows you to specify which datasheet is to be checked to determine the listedness (listed or unlisted) of the case.

Serious/Non-Serious

If you select Serious and clear Non-serious, only cases having a serious event are included and vice-versa. If you select both Serious and Non-Serious the seriousness criteria is ignored.

Fatal/Non-Fatal

Select Fatal when at least one event has an event outcome of Fatal. If not, select Non-Fatal. If you select both Fatal and Non-Fatal, both types of cases are included.

Listed/Unlisted

Select Listed to view only Listedness values. If you select both Listed and Unlisted, all Listedness values (including Unknown) are included.

Related/Non-Related

Relatedness refers to the more conservative of reported or company causality. Select Related for any reportable causality type, and Non-Related for any non-reportable causality type.

HCP/Non-HCP

HCP refers to cases that identify a Health Care Professional in the Reporter section within the General tab of the Case Form.

Primary Reporter Only

This checkbox displays whether the Primary Reporter has been selected to determine the HCP status.

7.1.4.6 Include line listing

Field

Description

Include Line Listing

Allows you to select whether you want the Line Listing Data Elements printed with the PSUR Report.

7.1.4.7 Add data elements

- Select the checkbox displayed against each data element to add it to the report.

- The unavailable fields are printed on the report by default and cannot be changed.

7.1.4.8 View selected data elements

This section lists the selected elements and enables you to arrange the order in which these are to be printed.

Field

Description

MedDRA Hierarchy from Cases/Dictionary

Select Cases to populate the data from the case data. Select Dictionary to populate the data from the MedDRA dictionary.

Print Only the Term (Preferred Term or Lower Level Term)

Prints only the event Preferred Term (PT) or event Lower Level Term (LLT) as per the selected radio button. Select the PT option to print only the preferred term and not the verbatim description.

Print Dose Text in place of regimen dose

Prints the dosage and frequency information from Dose Description field instead of Regimen Dose.

Indicate if case was expedited previously

This checkbox is selected if an agency has been selected in the Subject of Report tab. Cases for which an expedited report was previously submitted to the selected authority are marked with an asterisk and the date of submission appears in the line listing.
Any case that has been previously expedited to a selected agency, is listed in the list of Agencies in the Subject of Reports tab.

English Language

Provides the option to print the descriptions in English

Local Language

Allows a user to specify which Local language for a multi-language field is to be printed - namely, the Abbreviated Narrative field.

Print event info (Serious, Un-listed, Related) as Column

Check this checkbox to print the Seriousness, Listedness and Causality under the Event Verbatim column.
Events having listedness of 'Unknown' are considered 'Unlisted'. If only diagnoses are assessed for event assessment, the events which are associated with a Diagnosis but have been marked with Diagnosis as 'No' display '-' for both listedness and causality.

List cases only once, under the primary event

Select this option to view the details of cases in the Main Line Listing only once under the Primary Event

List cases under all events, details under the primary event

Select this option to view the details of cases in the Main Line Listing only once under the Primary Event, while non-primary events are listed under their respective event hierarchy with a reference to the primary event body system. Therefore, use this option when grouping on Main Line Listing is by the Event Body System.

Print Product Indication for the Product selected in the Report

Enables you to print the product indication for the product selected in the report.

7.1.4.9 Group cases

Field

Description

Available Groupings

Allows a user to group cases together from the given list. Select the desired groupings from the list and click Add to move the grouping to the Selected Groupings list.

Selected Groupings

Lists the added groupings, and reports the groups in the order they were selected. Up to 5 grouping options can be selected from the Available Groupings list.

Available Sortings

Allows a user to sort cases together from the given list. Select the desired sortings from the list and click Add to move the sorting to the Selected Sortings list.

Selected Sortings

Allows a user to further sort cases without a total count for each sorted item. Up to 3 sorting options can be selected from the Available Sortings list. This list is populated with the Mandatory Line Listing entities plus any optional data elements chosen for this configuration.

7.1.4.10 Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations/listings will appear along with the line listing. The system enables you to separate the cumulative summary by seriousness, relatedness, and listedness. If you choose this option, the system separates the product event detail into the following categories: Serious/Non-Serious, Related/Non-Related, and Unlisted/Listed events.

Field

Description

Include Index of Cases in PSUR

Create an index page of case numbers, for all cases included in the PSUR.

Include Summary of Cases Missing Assessments

This option creates a sub-report of cases missing one of the following items:

- Seriousness

- Case Causality

- Case Listedness

- Case Outcome

- Event Causality

- Event Listedness

Click this checkbox to create one or both of the following sub reports:

Cases Missing Assessments - This sub-report displays cases that have been included in the PSUR line listing, but one or more of the following have not been assessed:

- Case Seriousness

- Case Causality

- Case Listedness

- Case Outcome

- Event Causality

- Event Listedness

Cases Not Included in Report - This sub-report displays cases that have not been included in the PSUR line listing as a result of missing one or more of the following items:

- Lock Status

- Safety Date

- Uncoded Event

- Causality

Include Line Listing Tabulation

Check this checkbox to view a pre-defined summary tabulation of Report type, Seriousness and Listedness of all cases in the PSUR.

Additional Expedited Report Forms (CIOMS/MedWatch/VAERS)

Allows you to print CIOMS/MedWatch/AERS forms (as per selection) for its respective regulatory agency (as selection), for all cases in the report. It also provides an option to have (or not have) a watermark in the forms.

7.1.4.11 Include CIOMS reports

Field

Description

Print CIOMS reports for serious/unlisted cases

Allows a user to print CIOMS I forms for all Serious/Unlisted (Case Level) cases appearing in the PSUR.
CIOMS contain Internal or Other text printed on them when the PSUR is printed using the Internal or Other option.

Include Periodic Numbering on the CIOMS reports

Numbers the requested CIOMS I with a periodic format. (Namely, A-1-1 of 2, A-1-2 of 2, A-2-1 of 1, A-3-1 of 1 etc.). The index is modified to also contain the Periodic paging of each CIOMS report.

7.1.4.11.1 Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials

Field

Description

Include Section 6.2

Check this checkbox to include Section 6.2. By default, this is unchecked.

Cumulative Start Date

Enter the cumulative start date in this field. This field specifies the Start Date of the Cumulative date range. If not specified, the start date is picked from the date specified in the Inclusion Criteria. If specified, the application ensures that the date entered is a valid date, and is before the Start Date specified in the Inclusion Criteria.

Identify Study Cases using Report Type

Allows you to select the study cases that use report type from the multi-select list box. The values that are populated here, come from the Report Type codelist where the values display the This type includes cases from clinical trials as checked.

Group by Comparator

If the Product Type attribute is present in the Study Configuration for the Product being evaluated, this option is displayed. By default, this is unchecked. If this checkbox is selected, it displays sub columns based on Active Comparator names if Group by Comparator is selected. If Group by Comparator is not selected, the count is displayed under the name of the respective active comparator.

PBRER 6.2 Output for the non-company or non-configured study cases is fetched based on the following:

- When the case being evaluated is a non-company or non-configured study case, the suspect company products are printed with the product type as Medicinal Product.
The name of the medicinal product(s) is printed along with the counts:

- If the case and the study are not blinded, and the product type is identified as Investigational Product.

- If the case is unblinded (but the study is blinded), and the user has privilege to view the unblinded data.

- If the study is blinded but the case is unblinded, and you do not have privilege to view the unblinded data, the count is printed under Blinded.

- Counts for Active Comparator and Placebo are not expected for a non-company study cases as the comparator or placebo information cannot be determined for the non-company studies.Non-company study cases that do not have any company suspect products are not included in the case series and cumulative tabulations.

- If counts for Blinded, Active Compactor and Placebo are Zero, these columns are still displayed in the report with zero counts as the value.

- The report also prints SOCs with zero counts if there are no events reported.

7.1.4.11.2 Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources

Field

Description

Include Section 6.3

Check this checkbox to include Section 6.3. By default, this is unchecked.

Cumulative Start Date

Enter the cumulative start date in this field. This field users to specify the Start Date of the Cumulative date range. If not specified, the start date is picked from the date specified in the Inclusion Criteria. If specified, the application ensures that the date entered is a valid date, and is before the Start Date specified in the Inclusion Criteria.

Identify Spontaneous Cases using Report Type

Allows you to select the study cases that use report type from the multi-select list box. The values that are populated here, come from the Report Type codelist where the values display the This type includes cases from clinical trials as NOT checked. Only those values are included, where Display is set to Yes, in order to be consistent with the Report.

Identify Non-interventional Studies (UNION of rules below)

This is a mandatory field, comprising three new rules to identify Non-Interventional Studies: (Case Classification, Report Type, and Observe Study Type). These three new rules are displayed as checkboxes and have a section label called Identify Non-interventional Studies (UNION of the rules below).
This field is mandatory, which means that at least one of the options must be selected if Include Section 6.3 is selected.

Along with the three options, there is a multi-select list box for each that is populated with values from the respective codelist (given below) for the corresponding option that the user selected:

a. Case Classification is populated with values from Case Classification codelist.

b. Report Type is populated with values from Report Type codelist

c. Observe Study Type is populated with values from Case Classification codelist with ICSR code values that are not-null

All values are included in this list, irrespective of the Display field for Case Classification and Observe Study Type codelists. Those values where Display for Report Type codelist is set to Yes, are also included.

A + sign is displayed as a label, next to these options to indicate that it is a UNION of selections.

7.1.4.12 Add cumulative summary

Field

Description

Include Cumulative Summary

Select the checkbox to create a sub-report count of events, grouped by Product and Body System (SOC) and sorted by Preferred Term. The sub-report contains a previous date range count of events (comparative date range), a current date range count (current PSUR date range) and a cumulative count (all dates) of events assessed against the product(s) of the PSUR and matching the inclusion criteria.

Comparative Date Range

Allows a user to specify the previous date range as a comparison date for the events counted, and therefore should not overlap with the current date range specified on the PSUR inclusion criteria tab.

7.1.4.13 Add FDA PSUR support information

Field

Description

FDA PSUR Support Section
This section can be used if the company has obtained an FDA waiver to submit a PSUR instead of an NDA report.

Include Adverse Event Summary

Select this option to generate a sub-report of events from the line listing. This sub report is grouped by Body System and Preferred Term.

Causality

Select the desired causality from the list.
Ignore - Counts events regardless of causality assessment.

Causal - Counts events where the causality is considered reportable in the Causality Category configuration in List Maintenance.

Not Causal - Counts events where the causality is considered non-reportable in the Causality Category configuration in List Maintenance.

As Determined - Counts events where 'As Determined' causality meets the above selected causality criteria.

As Reported - Counts events where 'As Reported' causality meets the above selected causality criteria.

Both - Counts events where both 'As Reported' and 'As Determined' causality meet the above causality criteria.

Either - Counts events where either the 'As Reported' or 'As Determined' causality meets the causality criteria.

Only Cases with HCP Reporter

Check this checkbox to include events for only those cases that feature an HCP reporter

Diagnosis

Select this option to ensure that only events marked as diagnosis are counted.

Diagnosis & Symptoms

Select this option to ensure that all events are counted in the sub-report.

Separate Diagnosis & Symptoms

Select this option to include diagnosis and symptoms separately in the sub-report. Selecting this option means that the case numbers are separated by Diagnosis and Symptoms respectively.

Domestic Consumer Support

Select this option to enable domestic consumer support.

Print Unsubmitted

This option allows a user to print MedWatch or VAERS forms for U.S. cases

Exclude Reports that are Non-Serious and Listed

Allows a user to suppress MedWatch or VAERS forms from printing for Non-Serious listed cases where all events are non-serious and listed for the datasheet specified.

Use Periodic numbering on the Reports

Numbers the requested forms with a periodic format. (Namely, Periodic Page 1 - 1, Periodic Page 1 - 2, Periodic Page 2 - 1, Periodic Page 2 - 2, etc.) An index with the Case Number is also included.

7.1.4.14 Generate single case submission report

Field

Description

Single Case Submission Support Section

Generate Periodic ICSR Submissions for any cases in this Periodic Report that does not have at least one scheduled single-case report during the reporting period to the following Reporting Destination(s): Modify

Check this checkbox to generate the ICSR Reports only for the cases, where a Periodic ICSR Report for the message type chosen, does not exist.
Select one or more trading partners from the list box.

Important: Any case that does not have an expedited or single case periodic submission to a trading partner, must have an ICSR report scheduled as a part of the Periodic submission.

Click Modify to select a different Reporting Destination.

Schedule these single-case Periodic Reports to the following Reporting Destination

Select a single-destination trading partner for Periodic Reports from the drop-down list box.

Using the Message Type

Select the required message type from the drop-down list box

7.1.4.15 Select summary listing

The UD Summaries tab allows you to specify which summary listings will appear along with the line listing.

Field

Description

Include these summary tabulations/listings based on the set of cases presented in the line listing

Allows you to select from pre-configured summary tabulations/listings. These tabulations are based only on the data included in the line listing. Selecting the Exclude Follow-up Cases checkbox filters out follow-up cases from the attached report.
If the Exclude Follow-up Cases option is selected on the Inclusion criteria tab, this option is ignored and follow-up cases are always filtered out.

Include these summary tabulations based on all cases

Allows for additional sub-reports based on the 'Case Data Analysis' template, to be included as an output for the all cases in the database that meet the PSUR inclusion criterion for all dates.

Include these summary tabulations/listings based on the Date Range

This option allows for additional sub-reports based on Case Data Analysis, Case listing or CIOMS II line listing reports to be included as an output for the cases meeting the PSUR inclusion criterion for the Date Range specified when adding the sub-report.
The dates are based on either the Case Creation Date or the Initial Receipt Date as entered on the PSUR Inclusion Criteria tab. Check the checkbox to the right of the sub-report to ignore considering follow-up cases for the sub-report.

Identify SUSAR and Special Interest Events

Enables you to identify any SUSAR and special interest events.

Additional Separate Page Numbering for Summaries

Enables you to include additional separate page numbering for summaries.

7.1.4.16 Schedule the report

See Schedule the report

7.1.4.17 Setup frequency of the scheduled reports

See Setup frequency of the scheduled reports

7.1.4.18 Configure security level of the report

See Configure security level of the report

7.1.4.18.1 Use report templates

Refer to the Oracle Argus Dossier User Guide for a description of fields in the Templates tab.

7.1.5 Prepare content for a US IND periodic report

The system enables you to define an IND summary report. You can add a new report as well as copy, modify and delete existing reports.

7.1.5.1 Create new IND report

1. Select Reports, and click IND Reports to open IND Subject of Report view.

2. Click New Report.
OR

Select an existing report from the list and click Copy or Modify.

3. When you click New Report, the IND Line Listing Reports dialog box opens.

4. Enter an appropriate name for the report under Report Name.

5. Use the tabs in this dialog box to configure the IND Report.

6. From each tab in the IND Summary Report, you can choose to Print all configuration criteria on separate cover pages (PDF Only).

7.1.5.2 Enter common fields information

See Enter common fields information

7.1.5.3 Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency, products, and other elements. Select multiple ingredients for a configured IND Report to view the multiple licenses to be selected for the report.

Field

Description

Primary Agency

Select the Primary Agency.

Available Reporting Destinations

Displays the list of configured Regulatory Agencies. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.

Selected Reporting Destinations

Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.

Likewise, select an agency from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.

Company Name

If a regulatory agency is selected in the Subject of Report tab, then the company name associated with the regulatory agency (this association is created by the Administrator) is automatically entered in this field.

Product Name

This field is automatically filled as per the Ingredient field.
Check the checkbox corresponding to this field to choose whether you want this field to appear on the report.

Approval

This field is automatically filled with License numbers, separated by commas. This is an editable field.

Award Date

This field is populated with the earliest awarded Investigational License for US amongst the licenses selected. This field cannot be edited.
Check the checkbox corresponding to this field to choose whether you want this field to appear on the report.

Print all configuration criteria on separate cover page

Click this checkbox to print out the configuration of this report when the report is printed. This is only available when the PDF option is selected during printing.

Print page numbers on reports

When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.

- The Additional Separate Page Numbering for UD Summaries option on the IND Summaries Tabulation tab is grayed out and inactive.

- The system removes all existing report page numbering.

Allow access to report cases through Hit List

When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List.

7.1.5.4 Select products to generate the report

Use the Product Selection tab to select product information to include in the report.

Field

Description

Available Ingredients

Displays the list containing the Ingredients used for the product configuration. Select an ingredient from the list displayed in Available Ingredients and click Add/Remove to add/remove the ingredient.
You can select multiple ingredients at a time.

Filter

Enter an Ingredient name and click Filter to search for the entered ingredient within the Available list of Ingredients.

Selected Ingredients

Displays the list of ingredients selected from the Available Ingredients list.

Indication

This list contains a list of all the indications for the products containing the selected ingredient. The selections made from this list are displayed in the Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL key and clicking the different Indication entities.

Formulation

This list contains the Formulations configured for the product containing the selected ingredient and indication. The selections made from this list get displayed in the Selected Products section.
You can select multiple Formulations from the list at a time by pressing the CTRL key and clicking the different Indication entities.

Available Licenses

This list is automatically populated with the licenses from the Indication section.

Selected Licenses

This list contains licenses selected by the user from the Available Licenses list. When a product is selected, the Trade Name and International Birth Date fields are auto-populated with the license trade name (formulation, concentration) and earliest License Award Date for the product.

7.1.5.5 Select inclusion criteria

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a periodic report.

Field

Description

Case Creation Date

Allows you to specify a range of cases by the date when the case was created.

Case Receipt Date

Allows you to specify a range of cases by the initial receipt date.

Use Current Version

Allows you to use the latest revision to populate the data within the selected reports.

Use DLP Version

Allows you to use the case data of the version as of the specified DLP Version.

Age Groups

Allows you to include or exclude cases based on the patient's age group. Select the Age Groups checkbox to activate the age groups and select all the age group categories that apply.

Options - Domestic/Foreign Cases

This option allows the user to include domestic and foreign cases within the periodic report. Select Domestic if Country of Incidence is USA and Foreign if Country of Incidence is not USA.

Expeditable Only

This checkbox is available only when an agency is selected in the Subject of Report tab. If you check this checkbox, only the cases classified as submitted expedited reports to the primary agency are used.

Include Unlocked Cases

Allows you to include unlocked cases in the periodic report.

Advanced Condition

Allows you to specify an advanced condition that must be satisfied by each case that is included in the report. Ensure that the advanced condition or the advanced condition query set that is specified here does not contradict any other criteria specified in the dialog box.

7.1.5.6 Include line listing

Field

Description

Report All Events

Select this option to report all events.

Report only Diagnosis Events

Select this option to report only diagnosis events (only the diagnosis events that are either explicitly marked as diagnosis or are non-related symptoms).

List cases only once, under the primary event

Select this option to view the details of cases in the Main Line Listing only once under the Primary Event

List cases under all events, details under the primary event

Select this option to view the details of cases in the Main Line Listing only once under the Primary Event, while non-primary events are listed under their respective event hierarchy with a reference to the primary event body system. Therefore, use this option when grouping on Main Line Listing is by the Event Body System.

Create a Sub Report for Death Cases

Check this checkbox to separate death cases from the main IND listing. If the checkbox is checked, all death cases (Identified by any event marked as death in Seriousness Criteria or any event having an Event Outcome as Death) are filtered out from the IND Line Listing. All death case show up in a sub report, called IND Line Listing (Death Cases).

7.1.5.7 Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations will appear along with the line listing.

Field

Description

Include these summary tabulations/listings based on the set of cases presented in the line listing

Allows you to select from pre-configured summary tabulations/listings. These tabulations are based only on the data included in the line listing. Select the Exclude Follow-up Cases checkbox to filter out follow-up cases from the attached report.
If the Exclude Follow-up Cases option is selected on the Inclusion criteria tab, this option is ignored and follow-up cases are always filtered out.

Include these summary tabulations based on all cases

Allows for additional sub-reports based on the 'Case Data Analysis' template, to be included as an output for the all cases in the database that meet the IND Report inclusion criterion for all dates.

Add

Displays a list of memorized Case Data Analysis Reports that have been marked for availability in a periodic report.

Remove

Click this button to remove a selected report.

Additional Separate Page Numbering for Summaries

Enables you to include additional separate page numbering for summaries.

Include Summary of Unlocked Cases

Enables you to print the list of Case Numbers that are included in the Periodic Reports but are not locked.

7.1.5.8 Schedule the report

See Schedule the report

7.1.5.9 Configure security level of the report

See Configure security level of the report

7.1.6 Prepare content for an NDA periodic report

The NDA Periodic Reports enable you to define an NDA Periodic report. You can add a new report as well as copy, modify and delete existing reports.

- You can print an Index of Cases included in the NDA report.

- If you select this option, the system lists the cases from the following sections once at the end of the configuration pages:

- Sequential List of cases

- Serious Listed Initial/Follow up

- Non Serious Listed Initial/Follow up

- Non Serious Unlisted Initial/Follow up

- 15 Day Submission

- The page numbering for this sub-report continues from the configuration pages.

- You can separate initial case events from follow-up case events in the Summary Tabulation tab of the NDA Report.

- If you select this option, the system counts events in the Initial section if the case is in the Serious Listed, Non-Serious Listed, or Non-Serious Listed/Unlisted sections.

- If you select this option, the system counts events in the Follow-up section if the case is in the Serious Listed or Non-Serious Listed/Unlisted follow-up sections of the NDA report.

- For the 15 Day events, if the case has not been previously reported in a NDA, the system counts it in the Initial section then the Follow-up section.

- If you select List cases once under the Primary Event System Organ Class (SOC), the system displays a footnote with an asterisk ( * ) printed across all the System Organ Classes on the report and the following statement: Primary Event System Organ Class.

- If you select the Print FDA-3500A/VAERS form at the end option, the system prints the report sections in the following order:

- Configuration (Including Case Indices (e.g. Sequential Case Listing, Listing by Seriousness/Listedness, Listing of Cases Missing Analysis)

- Line Listing

- Summary Tabulations

- MedWatch/VAERS reports at the end of the report

- Page numbering for the MedWatch reports continue from the last page of the NDA report.

- The configuration pages have been updated to reflect the updates made to the NDA Reports

- The configuration pages are printed at the beginning of the NDA report.

- By default, these are unchecked on all the existing configured reports.

7.1.6.1 Create NDA summary report

1. Go to Reports, then select Periodic Reports, and click NDA Reports to open the NDA Subject of Report view.

2. Click New Report to create an entirely new report,
OR

Select an existing report from the list and click Copy or Modify.

3. When you click New Report, the NDA Line Listing Reports dialog box opens.

4. Enter an appropriate report name in the Report Name field

5. Use the tabs in this dialog box to configure the NDA Report.

6. From each tab in the NDA Report, you can choose to Print all configuration criteria on separate cover pages (PDF Only).

7.1.6.2 Enter common fields information

See Enter common fields information

7.1.6.3 Configure subject in the report header

On the Subject of Report tab you can select multiple Ingredients for a configured NDA Report per allowable variations of product and license configuration and periodic reporting requirements for the FDA. Select multiple ingredients to view the multiple licenses to be selected for the report.

Field

Description

Available Reporting Destinations

Displays the list of configured Regulatory Agencies. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.

Selected Reporting Destinations

Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.

Likewise, select an agency from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.

Company Name

If a regulatory agency is selected, the company name associated with the regulatory agency (this association is created by the Administrator) is automatically entered in this field.

Ingredient

This field is populated with ingredient selected in the Subject of Report tab.
Check the checkbox corresponding to this field to choose whether you want this field to appear on the report.

Approval

This field is automatically filled with License numbers, separated by commas. This is an editable field.

Trade Name

Automatically displays the Trade Name.
Multiple trade names are also populated from license trade name (formulation, concentration) of selected licenses, separated by commas.

Check the checkbox corresponding to this field to choose whether you want this field to appear on the report.

Award Date

Automatically displays the earliest license awarded date, when a user selects an Ingredient and a Product.
Check the checkbox corresponding to this field to choose whether you want this field to appear on the report.

Print all configuration criteria on separate cover page

Click this checkbox to print out the configuration of this report when the report is printed. This is only available when the PDF option is selected during printing.

Print page numbers on reports

When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.

- The Use Periodic Numbering on the reports option in the NDA Line Listing tab is grayed out and inactive

- The Additional Separate Page Numbering for UD Summaries in the NDA Summary Tabulations tab is grayed out and inactive.

- The system removes all existing report page numbering and the option to check page number checkboxes on the report configuration tabs are grayed out and inactive.

Allow access to report cases through Hit List

When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List.

7.1.6.4 Select products to generate the report

The Product Selection tab enables you to select product information to include on the report.

Field

Description

Available Ingredients

Displays the list containing the Ingredients used for the product configuration. Select an ingredient from the list displayed in Available Ingredients and click Add/Remove to add/remove the ingredient.
You can select multiple ingredients at a time.

Filter

Enter an Ingredient name and click Filter to search for the entered ingredient within the Available list of Ingredients.

Selected Ingredients

Displays the list of ingredients selected from the Available Ingredients list.

Indication

This list contains a list of all the indications for the products containing the selected ingredient. The selections made from this list are displayed in the Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL key and clicking the different Indication entities.

Formulation

This list contains the Formulations configured for the product containing the selected ingredient and indication. The selections made from this list get displayed in the Selected Products section.
You can select multiple Formulations from the list at a time by pressing the CTRL key and clicking the different Indication entities.

Available Licenses

This list is automatically populated with the licenses from the Indication section.

Selected Licenses

This list contains licenses selected by the user from the Available Licenses list. When a product is selected, the Trade Name and Award Date fields are auto-populated with the license trade name (formulation, concentration) and earliest License Award Date for the product.

7.1.6.5 Select inclusion criteria

Field

Description

Case Creation Date

Allows you to specify a range of cases by the date when the case was created.

Case Receipt Date

Allows you to specify a range of cases by the initial receipt date.

Use Current Version

Allows you to use the latest revision to populate the data within the selected reports.

Use DLP Version

Allows you to use the case data of the version as of the specified DLP Version.

Age Groups

Allows you to include or exclude cases based on the patient's age group. Select the Age Groups checkbox to activate the age groups and select all the age group categories that apply.

Option (Applicable to Non-15-Day Selection Only)- Domestic/Foreign Cases

This option allows the user to include domestic and foreign cases within the periodic report. Select Domestic if Country of Incidence is USA and Foreign if Country of Incidence is not USA.

Option (Applicable to Non-15-Day Selection Only)-
Exclude Literature Cases/Study Cases

This option allows the user to exclude Literature and Study Cases from being considered for the NDA Report. Select Exclude Literature Cases to exclude literature cases and select Exclude Study Cases to exclude study cases.

Advanced Condition

Allows you to specify an advanced condition that must be satisfied by each case that is included in the report. Ensure that the advanced condition or the advanced condition query set that is specified here does not contradict any other criteria specified in the dialog box.

Add Cases not Included in a previous reporting period Start Date

Enter the start date. This adds cases not included in a previous reporting period with the specified start date.

Include Unlocked Cases

Allows you to include unlocked cases in the periodic report.

Evaluate Primary Suspect Drug Only

Allows you to select only the Primary Suspect Drug.

7.1.6.6 Include line listing

The NDA report comprises of three tabs. The options for these tabs can be configured in the Line Listing tab.

Field

Description

Tab 1: FDA - 3500/VAERS Forms

Check this checkbox to generate the MedWatch 3500A (Drug) or VAERS reports which are serious listed or non-serious

Suppress printing of non-serious listed reports

Check this checkbox to prevent printing the non-serious listed reports but print their case numbers in the main NDA report indices
Tab 1 of the NDA Line Listing report cannot be generated without Tab 2. However, Tab 2 can be generated without Tab 1

Tab 2: Index of Submitted Forms in Tab 1

Check this checkbox to generate an index of the forms from Tab 1 It prints all MedWatch/VAERS forms for the following cases:

- Serious Listed

- Non-Serious Unlisted

- Non-Serious Listed

Previously expedited 15-day reports that are Serious and Unlisted that have already been submitted to the FDA do not need to be re-submitted with this periodic report

Tab 3 Part 1: NDA Line Listing of 15 Day Reports Submitted

Check this checkbox to generate a list of all serious unlisted expedited reports within the specified time period.
The dates in these reports are in GMT.

TAB 3 Part 2: Tabulation by System Organ Class (SOC) of All Event Reports Submitted

Check this checkbox to generate a tabulation by System Organ Class (SOC) of all events reported during the specified time period. This includes the cases for which expedited reports were previously generated, as well as the cases that are submitted as part of the current report

TAB 3 Part 3: Cases sent to FDA under another NDA

Check this checkbox to print a list of all the serious unlisted events for which reports were submitted to the FDA previously
Note: If you select to print out the Tab 3 Part 3 section, the NDA report looks for other submissions (E2B, MW, MW Drug, VAERS, eVAERS, eMDR) to the same agency for the same case against other (not included in selection criteria for this report) marketed licenses. Any submission matching this criterion is listed on the Tab 3 Part 3 section of the NDA report. If there are multiple submissions against different licenses, then each one is listed. Each license is listed only once

Include Periodic Submissions

Check this checkbox to include all cases that have been sent under another NDA

Start Page Number

Select the page number for the first page of the report

Listing Options

These options for List cases only once, under the primary event body system and List cases under all events body systems only apply to the NDA Line Listing of Expedited Reports Submitted report

List cases only once, under the primary event System Organ Class

Select this option to list cases only once

List cases under all events System Organ Classes

Select this option to list cases under each SOC for each event

Include Summary of Cases Missing Assessments

Check this checkbox to include a Summary of Cases missing Assessments at the end of the report

Include Summary of Unlocked Cases

Select this option to include a summary of unlocked cases

Include Listing of Nullified 15-day Alert Cases Submitted During the Reporting Period

Any case that was deleted which has submitted report within the reporting period after an expedited submission was made to the FDA (primary agency) for the license specified in the NDA Periodic report, regardless of the report form used, e.g., it could be MedWatch or Expedited E2B (E2Bs with MESSAGETYPE tag value configured as Expedited in Message Type Code List) or eVAERS.

Use Periodic numbering on the Reports

Select this option to use periodic numbering on reports

Custom Case Summary Tabulation

Enter the Summary Report Title

Advanced Condition

Select the Advanced Condition from the drop-down list

7.1.6.7 Specify summary tabulations for line listing

The Summary Tabulations tab allows you to specify which summary tabulations will appear along with the line listing.

Field

Description

Include these summary tabulations/listings based on the set of cases presented in the line listing

Allows you to select from pre-configured summary tabulations/listings. These tabulations are based only on the data included in the line listing. Select the Exclude Follow-up Cases checkbox to filter out follow-up cases from the attached report.
Note: If the Exclude Follow-up Cases option is selected on the Inclusion criteria tab, this option is ignored and follow-up cases are always filtered out.

Include these summary tabulations based on all cases

Allows for additional sub-reports based on the 'Case Data Analysis' template, to be included as an output for the all cases in the database that meet the NDA Report inclusion criterion for all dates.

Add

Displays a list of memorized Case Data Analysis Reports that have been marked for availability in a periodic report.

Remove

Click this button to remove a selected report.

Additional Separate Page Numbering for Summaries

Enables you to include additional separate page numbering for summaries.

Case Count Summary Report

Enables you to print the list of Case Numbers that are included in the Periodic Reports but are not locked.

7.1.6.8 Schedule the report

See Schedule the report

7.1.6.9 Configure security level of the report

See Configure security level of the report

7.2 View scheduled periodic report information

7.2.1 Available user options

Common features on the Period Reports page. Click the icon associated with each report to view the following options:

Option

Description

Description

Displays the report name. Click this to open the selected report in PDF format.

Status

Opens the Report Details dialog box for the selected report.

Print List

Allows the user to print the current Periodic Reporting for referencing the current view of the Periodic Reporting.

View Report

Opens the Individual Periodic Report selected by the user.

Report Details

Displays specific information about the report as entered in the Regulatory Reports section.
The information displayed in the fields of the Report Details dialog box is fetched from the data entered in the Regulatory Reports section of Case Form.

7.2.2 View report details

The Report Details > General tab displays the general information about the report. The information on this tab cannot be modified.

Field

Description

Agency

Displays the Reporting Destination for which the report is scheduled.

Responsibility

Displays the User Group to which the report is assigned.

Case Nullification Date

Displays the date when the case was nullified.

Case Nullification Reason

Displays the reason entered when a case is logically deleted in Argus.

7.2.3 View report schedule details

The Scheduling tab displays a reason for scheduling this report. It also shows the date on which the report was scheduled.

All fields in this tab are auto-populated as per records entered in Argus.

7.2.4 View report routing history

The Routing tab displays the routing history of the report. To route the report, click Route.

Field

Description

Group

Displays the group of the report. This button is enabled when you click the Route button.

User

Displays the state of the report. This button is enabled when you click the Route button.

Comments

Displays routing comments entered before routing the report.

7.3 Submit a periodic report

7.3.1 Specify submission details

The Submission tab enables you to specify whether submission is required and enter a reason for not submitting the report.

Field

Description

Submission Required

Enables you to select if this report is not required to be submitted to the regulatory authority.

Reason for Non-Submission

Click Select to select the reason for non-submission.

7.3.2 Add comments

The Comment tab enables you to enter a local comment that prints out on that specific report when generated. Each report has its own Local Comment section.

7.3.3 Transmit a report

1. Click the icon associated with a report and select the Transmission tab from Report Details.

2. The Report Details dialog box opens.

3. Click OK or Cancel to approve the transmission or discard any changes, respectively.

4. Click the Transmit button to transmit a report. The Transmit to Recipients dialog box is displayed.

5. Select the recipients of the report, as applicable from the Available Recipients list.

6. Select the method of transmission from Method, as applicable.

7. Enter remarks in Comments.

8. Click Transmit.

9. The selected report is transmitted to the specified recipients.

7.3.4 View report generation status

The Report Generation Status tab is displayed for users who have been configured by the Argus Safety administrator in Argus Console, under Access Management > Groups > Menu > Reports > Periodic Reports and for users who have access to the System Library.

Field

Description

Run At Date

Displays the date and time when the report generation started.
For English users, it is displayed in DD-MMM-YYYY HH:MM:SS (GMT offset) format.

For Japanese users, it is displayed in YYYY/MM/DD 00:00 (GMT offset) format

Status

Displays the current status of report generation in the form of hyperlinks, with the options listed below:

- Executing

- Error

- Pending

- Generated

On clicking the Generated status, the Periodic Report is displayed.

On selecting any status other than Generated, the Background Periodic Report Execution Status dialog box is displayed, as shown below:

This dialog box displays the different stages of Periodic Report status. A grey tick mark is denotes Pending state, a Green tick mark denotes Completed State, and a Red cross mark denotes an Error.

Context Menu > View Report

This option is displayed in the context menu only when PDF/CSV/DOCX Report Creation is Generated. On clicking View Report, the selected report is displayed. Applicable only for Periodic reports.

The Report Status screen displays the report outputs for the logged in user with the last report run as the first report. The reports can be filtered using:

- Report Name

- Draft/Final

- Report Type

- Scheduled By

- Scheduled On

- Run At Date

- Status

7.3.5 Create unscheduled periodic reports

1. Go to Reports, and select Compliance, then select Periodic, and click Create Unscheduled Report.

2. The system opens Periodic Reports dialog box that provides a list of configured reports of the following types:

- PSUR - Containing ICH PSUR Line Listing Reports

- IND - Containing US IND Periodic Reports

- NDA - Containing US NDA Periodic Reports

- CTPR - Containing CT Periodic Reports

3. Click the (+) icon against the desired category to view all the reports within that category.

4. Select the report you wish to create from this list and click Select.

5. When the system opens the Report Batch Printing dialog box, select Run Now or Run at, as appropriate.

Note:
If you select Run Now, specify PDF, DOCX, or CSV from the drop-down list for the report output option to generate the PSUR or CTPR report in the selected format.
If you select Run at, specify the date/time to schedule the PSUR report to be generated by Argus Safety Service. This enables only Final and disables all other Print As options.

6. In the Email field, enter the email ID of the user to whom the periodic report should be emailed, once completed. By default, this field lists the email address (if configured) of the current user.

7. Select what you want printed on the report: Final, Draft, Internal, or enter Other information.

8. Run Using allows users to select between Argus Native Periodic report and BI Publisher.

9. Report Form Type allows users to select the Report Templates and these options are dependent on the value selected in Run Using. If Run Using is selected as Argus Native, the Report Form Type drop-down list displays PBRER and PSUR. The option selected from this drop-down list is used as Report Form Type for follow-up algorithm.

10. The options displayed in the Report Form Type are configurable through the flexible codelist Report Template.

11. Click OK.

12. The system generates the periodic report.

7.3.6 Approve and submit a report

Before you can mark a report as submitted, the report must first be approved.

1. Open the case for which the report has to be approved.

2. Open the Regulatory Reports tab in the Case Form.

3. When the system opens the Regulatory Reports details for the selected case, click the icon associated with the report you wish to approve.

4. Select View Report Details.

Note:
The Case Nullification Date is the date when the case is deleted, the Case Nullification Reason is the comment entered when the case is logically deleted in Argus.

5. Select Submitted from the State list in the Routing tab and click Route.

6. When the system opens a dialog box, enter the required details and click OK.

7. The report is approved.

Note:
A user who has Workflow Manager rights can undo the submission of a report, if necessary.

7.3.7 View submitted reports

1. Go to Reports, then select Compliance, and click Submitted Reports.

2. When the system opens the Submitted Reports page, enter the appropriate search criteria and click Search.

3. The system displays the Search Results.

Submitted reports—fields and field descriptions

Field

Description

Case ID

Enter the specific case number.
Tip: Use wild cards such as 2007% to search for cases starting with 2007.

Include these Reports

Select the required report type or case status to be displayed.

Product

Select the product as required. The reports scheduled for these products will be displayed.

7.3.8 Use bulk report

Bulk Reporting enables you to print, transmit or submit reports in bulk.

1. Go to Reports, and then select Bulk Reporting to view the Bulk Report screen.

2. The system displays the screen.

7.3.8.1 Filter bulk reports

The Bulk Reporting Filter sections enables you to filter reports.

Field

Description

Destination

1. To filter reports by agency, select an Agency.
The agencies that have reports in the Scheduled, Approved and Generated states are displayed.

2. Click Filter to select multiple agencies from the Reporting Destinations dialog box.
The previous filtering criteria is saved and retained when the user invokes this dialog box. By default, all agencies are displayed.

Report Status

From the drop-down list, select one of the options:

- Generated Only—Displays the reports that have been generated (Generated, Approved, Disapproved and New Data Available states)

- Scheduled/Generated—Retains the existing behavior as it does today when this value is selected

- Pending

- Failed

- Printed/Transmitted

Note that to display Generated Only or both Scheduled and Generated reports, configure the common profile switch "Allows Bulk Reporting screen to show Generated Reports Only" as follows:

- For Generated Only reports, set the profile switch as "Bulk Reporting will allow filtering on generated reports only".

- For Scheduled/Generated reports, set the profile switch as "Bulk Reporting will allow filtering on both scheduled and generated reports".

Report Status

Choose either Scheduled/Generated, Pending, Failed, or Printed/Transmitted from the drop-down list.

Print Regulatory Report

Prints the report as Draft or Final. The Draft option is disabled when the printing option is set to Transmit.
Select Medical Summary to view the list of only medical summaries of distinct cases in a PDF.

Approved Reports Only

Filters reports for only approved reports.

View All

Displays the bulk reports applicable to your filter selections.

Product Family

Enter a Product family to view all cases where the scheduled reports belong to the searched Product family.

Study ID

Filters reports on the basis of the Study ID.

Product Group

Filters reports on the basis of the Product Group. If a value is selected in the Product Group filter, the Product Family drop-down list's values automatically narrow down to the product families which belong to the selected Product Group filter.

Specific Case #

To search a case, enter the Case Number, and click Retrieve.

7.3.8.2 View bulk report filter results

The filter search results appears in the Total Number of Rows section.

Field

Description

Suspect Product

Displays the Trade Name for which the report has been scheduled. If more than one Suspect Company Product exists for the case, an (+) is placed at the end of the product name.
For Reports which were scheduled for the Device, the Device name is displayed.

Diagnosis

Displays the Primary Event Diagnoses PT

(Event Verbatim)

Displays the (Verbatim as reported) of the Primary Event.

S/U/R

- Displays the Case Level Assessments:
- Serious (Y/N)

- Unlisted (Y/N)

- Causality (Y/N)

- Unknown is treated as a "?"

- The SUR link displays the Case Summary for the selected case.

F or LT

Fatal / Life Threatening

- If any of the events in the case are Fatal or Life Threatening F or LT is displayed.

- If the case is both F and LT, only F is displayed.

- If the case is neither F nor LT, only No is displayed.

7/15

Number of days for which the report is due.

- 7—if the report is within 7 days

- 15—if the report is due for more than 7 days

Blind Study Product

Transmits and prints study cases with blinded information.

Mark as Submitted

1. Select this option to mark reports as Submitted when the transmission or e-mail has been sent.
A confirmation dialog box appears if this option is not selected.

2. Select Yes or No.
This selection is remembered for the next time when you print a report.

Report Form

1. Displays the Description of the report
2. Click the Report form link to view the DRAFT Report as a PDF.

Destination

Displays the report destination (agency) for which the report is scheduled.

Downgrade

Allows the user to view if the report is downgrade.
Displays Yes if the report is a downgrade report else.

View All

Allows administrator and workflow manager to see all items in the system.

Tip:
The icon (displayed in the lock state) in the Reports > Bulk Reporting screen denotes a SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

7.3.8.3 Print reports in bulk

Field

Description

Blind Study Product

Check this checkbox to print study cases with blinded information.

Mark as Submitted

Check this checkbox to mark reports as Submitted when the transmission/email has been sent.
A dialog box is displayed is this checkbox is not selected. This dialog box prompts you to confirm if the report is marked as submitted or not.

Select Yes or No, as required. This selection is remembered for the next time when you print a report.

Print Medical Summary

Allows the user to print the Medical Summaries.

Print

Allows you to choose the printer for the selected report from the Select Site Printer dialog box.
Select the Site and Printer Name where you wish to print the report and click OK.

Print List

Allows the user to print the current view of the Bulk Reporting.

7.3.8.4 Sort cases

To sort the cases based on the case status, click the Lock State header row.

- Lock State

- SUSAR

- Exp/Per

These options enable you to sort cases based on the case categorization.

Tip:
The icon (displayed in the lock state) in the Reports > Bulk Reporting screen denotes a SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

7.3.8.5 Lock state icon options

Click the Lock State icon to view the list of available options.

Field

Description

View Report

Displays the Draft report.

Report Details

Displays specific information about the report as entered in the Regulatory Reports section.

Case Summary

Displays the Case Summary dialog box.

Remove Report

Deletes the report from the case on being asked for a justification.

Mark for Non-Submission

Displays the Submission tab in the Report Details dialog box.
Select No for Mark for Non-Submission and enter the reason for the non-submission.

7.4 Track your periodic report submission

7.4.1 Use submitted reports search results

Field

Description

Time Frame (I/F-u)

Displays the whether the report was initial or follow-up.

Product

Displays the first suspect product for the case on which the report is based (expedited reports).

License Type

Displays the license type of the report.

Primary Event

Displays the first event term for the case on which the report is based (expedited reports).

Reason for Scheduling

Displays the reason provided for scheduling the report.

Report Form

Displays the type of report scheduled (form) and initial/follow-up status (e.g. "Initial Report" or "Follow-up #3").

Submitted Date

Displays the report's submission date.

Case Del. Date

Displays the date when the case was deleted.

Blind Study Product

Enables you to mark the study product as blinded. When you manually schedule a report, the system enables you to check Blind Product Study on the Schedule New Expedited report dialog box to blind the study products if they are in the case.

Print All Submitted Reports

Enables you to print all the submitted reports.

7.4.2 Reopen submitted reports

Cases that are archived while unsubmitting reports can be reopened from the Archived Case dialog box.

1. Enter the password and notes required in the Archived Case dialog box.

2. When the system opens the Report Unsubmit dialog box, enter the reason for unsubmitting the report and click OK.

3. The system unsubmits the report.

Tip:
The icon (displayed in the lock state column) in the Reports-> Compliance - Expedited and Submitted screens denotes a SUSAR case.

7.4.3 About initial and follow-up cases in periodic reports

A case is categorized as follow-up only if it has been previously submitted to the same regulatory agency, report form type and configured product/licenses or study. Otherwise, it is considered initial.

7.4.4 View batch reports scheduled for generation

1. To view this list of System, Expedited, and Periodic reports that scheduled for generation, from the Utilities drop-down menu, select Batch Reports.

2. To delete a batch report, select the corresponding checkbox, and click Delete.

8 Work in a multi-tenant Argus environment

8.1 Access your global worklist items

1. Enter the URL address for the Global Portal homepage in a browser window.

2. In the Application Access Portlet, select a tenant from the Enterprise drop-down list, and an Argus application to launch from the Application drop-down list.

3. Select the Global Worklists tab.

Note:
The data from Global Worklists is not exclusively Argus Safety data. In addition to Argus Safety, you can also access data from Argus Insight and Argus Affiliate for the selected tenant.

4. To view global worklist items based on user assignment, from the top right of the screen, select one of the following:

- Individual — For worklist items assigned to you across the tenants you are authorized for.

- Group — For worklist items assigned to any other member of your user group across tenants you are authorized for.

- All — For worklist items across all user groups across tenants you are authorized for.

Note:
This option is available only if you have the Workflow Manager right.

5. To further narrow the search results based on specific work item details, enter search criteria in the relevant fields in the grey area at the center of the page.

Tip:
You can use predictive text to complete these fields.

6. Click the link for a case number.

8.2 FAQs

8.2.1 What is a tenant?

A tenant is a client to which a CRO assigned a logical section of the Argus Safety environment within multi-tenancy. Depending on business needs, tenants can use specific data configurations and access distinct Argus Safety modules. However, they cannot access data that belongs to other tenants. Each tenant has a unique identifier in multi-tenancy called enterprise ID.

8.2.2 What is multi-tenancy?

Multi-tenancy is an Argus Safety feature that can be enabled with Single Sign-On to allow CROs to share their environment between multiple independent clients called tenants. The environment is partitioned so that the tenants can access specific Argus Safety modules and use customized data configurations as needed.

In multi-tenant environments, authorized SSO users can review cases and case actions, and manage worklist items that they are responsible for across any number of tenants.

8.2.3 Can I open both the Global Portal homepage and the Argus Safety application in my browser?

Yes, you can open both sites by entering their URL addresses in different tabs in your browser.

8.2.4 Can I open the Argus Safety application a second time for the same or a different tenant?

Yes, you can open Argus Safety a second time for the same or a different tenant. However, the application will open in the same browser window in which the application is already open.

8.2.5 Can I open the Argus Safety application for different tenants?

Yes, you can open the Argus Safety application for different tenants, provided you close the Argus Safety application for the existing tenant before you open it for a new one.

8.2.6 Can I launch different Argus applications in separate browser windows?

Yes, you can launch different Argus applications in separate browser windows. However, if you attempt to open the same Argus application for the same or a different tenant, the application will open in the same browser window in which the application is already opened.

8.2.7 Is there a Japanese version of the Global Portal homepage?

The Japanese version of the Global Portal homepage and related screens is not supported yet. However, the features and functionalities that are specific to Argus Safety Japan and Argus J users apply also to multi-tenancy environments.

8.2.8 Which actions can I perform from my global worklist?

Depending on your role and access rights, you can use your global worklist to:

- Search for a case.Perform case actions on a case, for example Open as Read-only, Accept Case, Adjust Priority, Adjust Assignment, Adjust Case Owner, Close Case, perform Coding Review or Medical Review, view a Case Summary.Manage your worklist items, for example Close Action Item, Print Worklist, or Generate Letter.

8.2.9 Can I perform actions on multiple cases from my global worklist?

Global Worklist pages do not support simultaneous actions on multiple cases, such as Close Multiple Cases, Route Multiple Cases, Print Multiple Cases, and Assign Multiple Cases. These options are only available on the Argus Safety Worklist Open page.

8.2.10 Can I open Argus Safety cases for multiple tenants from my global worklist?

No. If you have an open Argus Safety case for a tenant, you must save and close the case before you open a case for another tenant.

8.3 What If

8.3.1 There are no items in my global worklist

If no work items appear in your global worklist, then you are not authorized for any tenant.

8.3.2 I can't see cases for a tenant even though I used its Enterprise ID as search criteria for my global worklist

The results list from your global worklist shows cases only for tenants you are authorized for.

8.3.3 The results list from my global worklist includes case data items that are not referred to by worklist menu actions

The fields and columns from your global worklist results list are configurable by Administrators. If the respective field or column is not relevant for your work actions from your global worklist, contact your Administrator to configure it as hidden.

8.3.4 A case data item appears in my Argus Safety worklist, but does not appear in the results list from my global worklist

The respective case data item may be configured as hidden in your global worklist. Contact your Administrator to change the setting for the item to visible.

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Pre-General Availability: 2020-01-15

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