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Contents

Title and Copyright Information

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