Oracle® Argus Affiliate

User's Guide

Release 8.1.1

E87511-01

September 2017

Oracle Argus Affiliate User's Guide Release 8.1.1

E87511-01

Copyright © 2016, 2017 Oracle and/or its affiliates. All rights reserved.

This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited.

The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing.

If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, then the following notice is applicable:

U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and adaptation of the programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to the programs. No other rights are granted to the U.S. Government.

This software or hardware is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software or hardware in dangerous applications.

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark of The Open Group.

This software or hardware and documentation may provide access to or information about content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services unless otherwise set forth in an applicable agreement between you and Oracle. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services, except as set forth in an applicable agreement between you and Oracle.

Contents

Preface

- Where to Find More Information

- Documentation Accessibility

1 Product Overview

- Argus Affiliate Process Overview

- User Types

- Getting Started

- Required Fields

- Standard Buttons

2 Affiliate Users

- Logging On

- Viewing the Worklist

- Pending Central Actions

- Not Routed

- Cases Pending Local Labeling

- Creating Local Events

- Entering Event Information

- Adding a Letter

- Routing Events to Central

- Searching for Local Events

- Opening Local Events

- Performing Local Labeling

- Submitting Reports

- Bulk Reporting

- Bulk Reporting Filter Section

- Total Number of Rows Section

- Printing Options

- Suppress Default Printer option in Select Site Printer dialog

- User Options

- Lock State Header Options

- Lock State Icon Options

- Viewing Report Details

- About the Report Details Dialog Box

- General Tab

- Scheduling Tab

- Submission Tab

- Comments Tab

- Viewing Report Submission History

- Report Submission Tabs

- Changing Your Password

3 Central Users

- About Central Users

- Viewing the Worklist

- Pending Central Actions Tab

- Not Routed Tab

- Action Items from Local

- Action Items from Central

- Cases Pending Local Labeling Tab

- Intake Worklist

- Reviewing Incoming Events

- To review incoming events

- Searching for Duplicates

- Accepting Local Events

- Accepting Events for Initial Cases

- Accepting Events for Follow-up Cases

- Entering Follow-up Information

- Accepting Follow-ups from Affiliate for Archived Cases

- Accepting Follow-ups from Affiliate for Locked Cases

- Accepting Follow-ups for Open Cases

- Rejecting Local Events

- Encoding Events

- Locking Cases

- Viewing Affiliate Report Submission

- About the Report Submission Page

- Submitted Reports Only Tab

- Non-Submit Reports Tab

- Pending Submission Tab

- Medical Review

- Common Features in Medical Review

- About Medical Review

- Case Narrative Section

- Case Assessment

- Event Assessment

- About Temporal View

- About Action Items

4 Affiliate Configuration

- Creating User Groups

- Using Organized By

- Creating User Accounts

- Field Descriptions

- Adding Users

- Using Organized By

- Configuring the Affiliate System Numbering

- Viewing the Audit Log

- Searching the Audit Log

Glossary

Preface

This book describes the Argus Affiliate configuration, as well as the functions performed by Central Users and Affiliate Users.

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.

1 Product Overview

The Argus Affiliate Module enables users from a company's local affiliates to manage and track cases that are specific to their workflow. It is the complete and seamless solution that allows for case data from affiliates to be entered at the source, a complete case review, acceptance of the case into the central database, and determination if a case is reportable at the local level.

Argus Affiliate Process Overview

The following table lists some of the main tasks that users perform when using Argus Affiliate.

Task

Description

Log on to Affiliate

Log on to the Local Affiliate Module using a Local Affiliate account.

Enter Local Event Information

Enter information about local events.

Route Events to Central

Send the events to Central Safety for review.

Log on to Argus Safety Web

Log on to Argus Safety Web as a regular Argus Safety user.

Review and Accept Local Events

View events sent by local affiliates around the world and accept these events.

Encode Events

Encode the events sent in by Local Affiliates.

Perform Local Labeling

Label events for cases that are pending labeling.

Submit Reports

Submit reports according to the requirements of local regulatory authorities.

User Types

The following two broad categories of Argus Affiliate users can exist:

Central Users - These are users that belong to the Central Safety site of a pharmaceutical company.

Affiliate Users - These are users that belong to other global sites of the company or its local affiliates. Affiliate sites may fall under different regulatory reporting requirements compared to the Central Safety site and other affiliate sites.

Getting Started

Refer to the following sections for information about required fields and standard buttons used in Argus Affiliate.

Required Fields

Fields that are marked with a red flag image and have an orange boundary are required fields. These fields must be filled in to proceed with the configuration requirements.

Standard Buttons

The standard buttons used in Argus are described in the table below:

Button

Purpose

Save

Use this button to save changes associated with an event.

Cancel

Use this button to cancel changes associated with a section.

Print

Use this button to print information associated with an event, in PDF format.

Add

Use this button to add an item associated with a section.

Delete

Use this button to delete an item associated with a section.

Copy

Use this button to create a new editable copy of an item within a section.

OK

Use this button to confirm an action associated with a section.

Yes

Use this button to confirm an action associated with a section.

No

Use this button to cancel an action associated with a section.

Help

Use this button to launch the online manual.

2 Affiliate Users

This chapter describes the tasks that can be performed by the Affiliate Users of Argus Affiliate. This chapter contains the following topics:

- Logging On

- Viewing the Worklist

- Creating Local Events

- Entering Event Information

- Routing Events to Central

- Opening Local Events

- Performing Local Labeling

- Submitting Reports

- Bulk Reporting

- Viewing Report Details

- Viewing Report Submission History

- Changing Your Password

Note:
To access the LAM user interface, users must first log on to Argus Affiliate using the user name and password that have been provided to them.

Logging On

Use the following procedure to log on to Argus Safety Web.

To log on to Argus Safety Web

1. Open Microsoft Internet Explorer.

2. Under Address, enter the URL for Argus Safety and press ENTER.

3. When the log-on screen opens, enter your Argus user name, password, and select the required database from the list.

4. Click Login.

Viewing the Worklist

In the Argus User Interface, select Worklist from the Local Affiliate Menu to access the different options available through this screen.

The following table lists and describes the different views:

View

Description

Pending Central Actions

Displays actions on local events that are pending at central

Not Routed

Displays local events that have not yet been routed to central

Cases Pending Local Labeling

Displays pending action items that have been assigned to the Local Affiliate Users.

Action Item from Local/Central

Displays pending action items from Local/Central Users.

Pending Central Actions

The following tables lists and describes the fields on the Pending Central Actions tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Central Case Number

Displays the central case number.

Local Affiliate Number

Displays the name of the local affiliate.

Actions/Routing Comments

Displays any actions or routing comments for the case.

Print List

Prints the list displayed in the screen in a PDF.

Not Routed

The following table lists and describes the fields in the Not Routed tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Primary Suspect Product

Displays the name of the primary suspect product.

Primary Event

Displays the name of the primary event.

Country of Incidence

Displays the country where the adverse event occurred.

Local Affiliate Name

Displays the name of the local affiliate.

Print List

Prints the list displayed in the screen in a PDF.

Cases Pending Local Labeling

The following table describes the fields on Cases Pending Local Labeling tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Primary Suspect Product

Displays the name of the primary suspect product.

Central Case Number

Displays the case number with Central.

Primary Event

Displays the name of the primary event.

Country of Incidence

Displays the country where the adverse event occurred.

Local Affiliate Name

Displays the name of the local affiliate.

Print List

Prints the list displayed in the screen in a PDF.

Creating Local Events

The system permits you to create local events.

To create local events

1. In the Local Affiliate menu, select Create Local Event to open the Local Event Entry form.

2. When the system opens the Local Event Entry Form, enter the appropriate information in the fields.

The following table lists and describes the fields on the Local Event Entry form.

Item

Description

Product Name

Enter the name of the product which is associated with the case. If the adverse event(s) is associated with more than one product, each of the additional product can be added from the Case Form. It is advisable to enter the most suspect product here.
You can click Select to search for a product from the Trade Name Product Lookup dialog. Several items will be automatically entered on the Case Form based on the product selected here.

1. Click on Select. The Product Browser window appears.

2. Enter the Ingredient key word for the search. The ingredient is displayed in the first column.

3. Select the Ingredient to obtain the Family it is associated with.

4. Select the Product Name to view the associated Trade Names.

5. Select the Trade Name required.

6. Select is now enabled at the bottom of the window. Click Select to add the product details

Report Type

From the list, select the item that best describes the type of report. The report type chosen here will determine which fields will be available for entering case information. The report type will also impact the duplicate search.
For example, selecting "Sponsored Trial" will make the Study ID and Protocol ID fields available. The Administrator can adjust the information in this list.

Receipt Date

Enter the date on which your company became aware of the case.

Study Number & Center ID

The Study Number and Center Id fields are enabled when the Product details are filled in this section.
Enter the ID for the Center.

You can click Select to search for a study from the Study Name Lookup dialog. Several items will be automatically entered on the Case Form based on the product selected here.

Steps to select the Center Id

Click Select to open the Clinical Trial Selection dialog.

Select the Project from the drop-down list and enter the Study details as applicable.

A list of centers associated with the row that you select appear at the bottom of the dialog.

Highlight the required clinical study and study center and click Select.

Reporter First Name Reporter Last Name

Enter the reporter's first and last name.

Country of Incidence

Enter the country where the adverse event occurred. In Argus Safety application, you can either type the complete country name, or enter a two letter country code that will automatically be decoded. In Argus Safety Web, you can select the appropriate country from the list.
Note: This may or may not be the reporter's or the patient's country of residence.

Patient Initials

Enter the patient's initials.

Patient Date of Birth

Enter the patient's date of birth.

Patient Gender

Enter the patient's gender.

Event Description

Enter a brief verbatim description that describes the event that is most clinically important in the case.

Onset Date

Enter the date for the onset of adverse event symptoms.

Keyword

Enter a keyword when searching for duplicates. Keywords are only used for searching for cases.

Receipt Range Limits

Select this check box to search for cases that have been entered in the range of 60 days before the current date and 60 days after the current date.

Tip:
You can click Search to determine if this case has been entered before. A list of cases that match the search criteria appears. Inspect the list and determine if any case matches the event information that is to be entered.

3. Click Create Local Event to create a new local event. The Local Event- Initial Event Entry screen appears.

4. Enter the available event information in the AE Entry and Local Info tabs.

Refer to "Entering Event Information" for further instructions.

Entering Event Information

When entering event information in the AE Entry and Local Info tabs, be aware of the following:

- Click Add to add another row to the section.

- Click the Zoom icon to enter text or notes in a separate window. You can also check the spelling of the text in this separate window.

To enter text information

1. Open the AE Entry tab.

2. Enter the available event information in each of the sections of the AE Entry tab as shown in the following tables.
General Section

Item

Description

LAM Use Only

Select this check box if this event is for local usage only and will not be routed to Central.

Central AE Case Number

The case number that is assigned to this event at Central will be entered here. No text can be entered in this field when initial event information is being entered.

Report Type

Select the type of report.

Receipt Date

Enter the Receipt Date. This date will be used at the Central end.

Affiliate Date

Enter the date received.

Country of Incidence

Select the country in which this event occurred.

Local Reference Number

The number by which the event is identified is entered here. This number will be automatically generated if the system has been configured to automatically number local events.

Case Narrative

Enables the user to enter a narrative description of the case.

Case Comment

Enables the user to enter relevant comments about the case.

Follow up Received

Enter the date on which follow up information was received at the local affiliate location.

Safety Received

Enter the date on which the follow-up information was received by the Central safety office.

Significant

Select this check box if significant follow-up information has been received.

Patient Information Section

Item

Description

Initials

Enter the initials of the patient.

Date of Birth

Enter the date of birth of the patient.

Age/Age Unit

Enter the patient's age and the age units used.

Gender

Enter the patient's sex.

Patient ID

Enter the patient's identification number. Note: This field is available only if the event is associated with a clinical trial or other study.

Study Number

Enter the study number. Note: This field is available only if the event is associated with a clinical trial or other study.

Other Relevant History Section

Item

Description

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.

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.

Ongoing

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

Condition Type

Select a condition type from the list. The Administrator can adjust this list.

Description as Reported

Enter the verbatim term used by the reporter, or patient, to describe the adverse event or product name.

Notes

Enter any notes pertinent to relevant history.

Reporter Information Section

Item

Description

Address

The address of the institution.

City

The city where the institution is located.

Country

The Country where the institution is located.

Department

The name of the reporter's department

Email Address

The email address for the reporter.

FAX Number

The fax number for the reporter.

First Name

The first name of the reporter.

Health Authority Case Number

The Health Authority Case Number.

Health Care Professional

Indicates whether the reporter is a health care professional.

Institution

The name of the institution where the reporter is currently employed.

Intermediary

Identifies the intermediary for the case.

Last Name

The last name of the reporter.

Middle Name

The middle name of the reporter.

Occupation

Displays the occupation of the reporter.

Postal Code

The postal code where the institution is located.

Protect Confidentiality

Indicates that the reporter's identity is protected in expedited reports.

Dosage Regimen Dose Description

User this field to describe non-standard dosages that cannot be adequately described using the dose, route, and frequency fields. Note that the initial value for this field defaults to the dose, route, and frequency information and can be amended as appropriate.

Report Media

Displays the method used to report the case.

Reporter Type

Identifies the reporter type.

Sal.

Identifies the title of the reporter.

State

The state where the institution is located.

Suffix

Displays the reporter's suffix, if appropriate.

Event Information Section

Item

Description

Onset Date

Enter the date/time the event started. You can enter a partial date if the complete date is unavailable.

Stop Date

Enter the date/time the event stopped.

Event Description

Enter the verbatim term used by the reporter to describe the adverse event. As you type, the system automatically copies the term in to the Description to be Coded field.

Death

Click the appropriate box to select the Serious Criteria for the event.

Hospitalized

Click the appropriate box to select the Serious Criteria for the event.

Disability

Click the appropriate box to select the Serious Criteria for the event.

Other

Click the appropriate box to select the Serious Criteria for the event.

Other Text

Enter text to describe the other type of serious event.

Medically Significant

Click the appropriate box to select the Serious Criteria for the event.

Life Threatening

Click the appropriate box to select the Serious Criteria for the event.

Intervention Required

Click the appropriate box to select the Serious Criteria for the event.

Congenital Anomaly

Click the appropriate box to select the Serious Criteria for the event.

Symptoms

Enter the appropriate symptoms for the cases.

Outcome

Select the outcome of the event from the drop-down list (e.g., recovered, improved, fatal, etc.) The Administrator can adjust the information on this list. If Fatal is selected, Death is check in the list of seriousness criteria.

Duration

The system automatically calculates this field from the event start and stop dates. If duration is greater than five (5) days, the system only displays days. You can enter or modify the duration manually.

Diagnosis/Symptom

Click the appropriate radio button to indicate whether the event is a diagnosis. Clicking Yes marks this event as the primary event. In case of multiple diagnosis events, the event on the left is considered as the primary event. Click Relationships to display the Event-Relationships dialog. This enables you to group symptoms and signs with diagnoses.

3. Open the Local Info tab.

4. Enter the available case information in each of the sections of the Local Info tab as listed in the following tables.
Contact Log Section

Item

Description

Date

Enter the date associated with the letter.

Code

Enter the contact code associated with the letter.

Description

Enter the description associated with the letter.

User

Select the user to whom the letter is to be sent.

Date Sent

Enter the date on which the letter was sent.

Action Items Section

Item

Description

Date

Displays the date associated with the Action Item.

Code

Displays the code associated with the Action Item.

Description

Displays a description of the Action Item.

User

Displays the user to whom the Action Item is assigned.

Due Date

Displays the date on which the Action Item is due.

Date Completed

Displays the date on which the Action Item was completed.

Notes and Attachments Section

Item

Description

Attach Documentum Link

Displays the Documentum Lookup Dialog. Use this dialog to search for and select Documentum links.

Attach File

Click Attach File to add an attachment. Browse to the location of the file on your system.

Date

Enter the date associated with the note or attachment.

Classification

Select the type to which the attachment belongs.

Description

Enter the description of the attachment.

Item

Description

Keywords

Enter the keywords relevant to the attachment. To select a keyword from a list, click Select.

Select

Click Select to enter a new keyword or select a keyword from the list.

Routing Comments Section

Item

Description

Date

Displays the date on which the event information or follow-up information was routed to Central.

Route By

Displays the user who was responsible for the routing.

Comment

Displays the routing comments.

5. Add letters as necessary. Select Save in the Local Affiliate menu to save the case.

Note:
For follow-up information associated with an event, enter the follow-up information and then route the event to Central.

Adding a Letter

Use the following procedure to add a letter.

To add a letter:

1. In the Contact Log section of the Local Info tab, click Add.

2. Click in the row to select it and click New Letter.

3. Select a letter template from the list and click OK. The letter will open in a separate Internet Explorer window.

4. If you make changes to the letter, save the letter on your system by selecting Save As in the File menu of Internet Explorer.

5. Close the Internet Explorer window.

6. In the Save Letter dialog, click Yes to save the modified letter or No to save the automatically generated letter without the changes you made.

7. If you click No, the letter will be inserted in the new contact log row.

8. If you click Yes, the Attach Letter for LAM dialog appears. Attach the letter that you saved on your system in step 4 by clicking Browse.

9. When a new letter is added, an action item corresponding to that letter is inserted in the Action Items section.

Routing Events to Central

When routing local events, be aware of the following:

- The system disables the routing button after the event is routed and enables it again when Central accepts the event.

- You can route a local event for the first time even if there are multiple Argus Affiliate follow-up receipt dates entered.

- When you route a local event after the first time and all the Argus Affiliate Follow-up Receipt Dates are blank or grayed out (read-only), the system does not permit routing and presents a popup message.

- After successfully routing a local event, the system makes the following fields read-only:

- Argus Affiliate Follow-up Receipt Dates

- Argus Affiliate General Receipt Date

- Argus Affiliate General Affiliate Date

- Argus Affiliate Follow-up Safety Date

- Significant Checkbox

- After successfully routing a local event, the system grays out all the existing follow-up date rows; you cannot delete the grayed out rows.

To route events to Central:

1. Open the event that is to be routed to Central.

2. The AE Entry tab opens when the event is opened.

3. Open the Local Info tab.

4. Scroll to the Routing Comments section and click Route to open the Local Affiliate dialog box.

5. Click OK to open the Routing Confirmation dialog box.

6. Enter your Password and Comment and click OK.

7. When the Route to Central dialog appears opens, click OK.

Searching for Local Events

Use the following procedure to search for local events.

To search for local events:

1. Select Local Event Search from the Local Affiliate menu to open Local Event Search form.

2. Under Search for, select the item by which the search is to be done.

3. Enter the relevant search text in the text box.
For example: To search for local events by local tracking number, select Local Tracking Number in the list and then enter the tracking number which is to be searched.

4. Select the product family to which the event is related under Product Family.

5. Enter the text that describes the event under Event.

6. Select the date range in which the event was entered under Date Range.

Tip:
To specify your own date range, select Custom Date Range. Enter the dates in the Custom Date Range dialog and click OK.

7. Click Search to view the list of search results.

Opening Local Events

Use the following procedure to open local events.

To open local events:

1. Select Local Event Search from the Local Affiliate menu to open the Local Event Search form.

2. Enter the search conditions to search for local events.

3. Find the required event in the search results.

4. Click the link associated with the Local Tracking Number of the required event to open it.

Performing Local Labeling

Use the following procedure to perform local labeling.

To perform local labeling:

1. Select Local Labeling from the Local Affiliate menu to open the Local Labeling screen.

2. Select Pending to view cases that are waiting for labeling.

Pending Tab Field Information:

The following table lists and describes the fields on the Pending tab.

Field

Description

LAM Event Number

Displays the LAM event number. The link displayed in this field helps you in viewing event information.

Case Number

Displays the case number with Central.

Product

Displays the name of the primary suspect product.

Event PT (Description) / LLT

Displays the name of the primary event.

D/S

Displays if the event was diagnosis or symptom.

Seriousness

Displays all the seriousness criteria for the event.

Severity

Displays the severity for the event.

Duration

Displays the duration for the event.

Datasheet

Displays the datasheet(s) for the agent.

License

Displays the license(s) for the agent.

Listedness

Displays the listedness of the drug. Values may include Listed, Labeled, Unlisted, Unknown.

Marked as Assessed

Allows the user to mark whether local assessment is done against the licenses displayed for the product or not. It provided 3 methods to mark this status at 3 different levels.1) Assessed checkbox at License Level: This checkbox allows users to specify the local assessment status at each license level. It shall be available in both Pending and Historical tabs.2) Assessed checkbox at Database Level: This checkbox allows users to specify the local assessment status at each datasheet level. If user checks or un-checks this checkbox, it shall automatically update all the license level checkboxes under this datasheet accordingly. It shall be available in both Pending and Historical tabs.3) "Assessed" button at Product Level: Clicking on this button shall mark all the licenses and datasheet level checkboxes as checked. It shall only be available on Pending tab.

3. Select Historical to view cases that have been assessed.

Historical Tab Field Information

The following table lists and describes the fields on the Historical tab.

Field

Description

LAM Event Number

Displays the LAM event number. The link displayed in this field helps you in viewing event information.

Case Number

Displays the case number with Central.

Product

Displays the name of the primary suspect product.

Event PT (Description) / LLT

Displays the name of the primary event.

D/S

Displays if the event was diagnosis or symptom.

Seriousness

Displays all the seriousness criteria for the event.

Severity

Displays the severity for the event.

Duration

Displays the duration for the event.

Datasheet

Displays the datasheet(s) for the agent.

License

Displays the license(s) for the agent.

Listedness

Displays the listedness of the drug. Values may include Listed, Labeled, Unlisted, Unknown.

Marked as Assessed

Allows the user to mark whether local assessment is done against the licenses displayed for the product or not. It provided 3 methods to mark this status at 3 different levels.1) Assessed checkbox at License Level: This checkbox allows users to specify the local assessment status at each license level. It shall be available in both Pending and Historical tabs.2) Assessed checkbox at Database Level: This checkbox allows users to specify the local assessment status at each datasheet level. If user checks or un-checks this checkbox, it shall automatically update all the license level checkboxes under this datasheet accordingly. It shall be available in both Pending and Historical tabs.3) "Assessed" button at Product Level: Clicking on this button shall mark all the licenses and datasheet level checkboxes as checked. It shall only be available on Pending tab.

4. Enter the Case Number, if it is known.

5. Click Search to view the list of events, grouped by the Local Event Number.

6. Under Local Labeling, select the appropriate labeling for each product associated with the event.

7. Select the Assessed checkbox for the labeled case and click Mark as Assessed to mark the selected case for a Preferred Term. The system enables the Process button.

8. Click Process to save the labeling changes.

9. The selected report is displayed in a PDF.

Submitting Reports

Use the following procedure to submit reports.

To submit reports:

1. Select Report Distribution from the Local Affiliate menu to open the Report Distribution page.

Report Distribution Fields:

The following table lists and describes the fields on the Report Distribution page.

Field

Description

Action

Enables you to view and select the different options available as action items.

Case Number

Enables you to search for a case based on its case number.

Report Type

Displays the type of report.

Country of Incidence

Displays the name of the country where the adverse event occurred.

Suspect Product

Displays the name of the suspect product.

Diagnosis (Verbatim as reported)

Displays the diagnosis made for the event.

Core

Displays the core labeling made for the event.

S/U/R

Displays whether the case is serious unrelated or related.

F or LT

Displays if the event is Fatal or Life-Threatening.

Report Form

Displays the name of the report in a link.
Click the link to view the report in a PDF.

Destination

Displays the destination name.

Initial/Follow-up (#)

Displays if the report is an initial report or a follow-up report.

Date Due

Displays the date when the report is due.

Days Open

Displays the days since when the report has been open.

License Type

Displays the license type of the report.

Submission Status

Displays the submission status for the report.

2. Use the standard filters provided for Case Number, Report Type, Country of Incidence, Suspect Product, Diagnosis, and so on to filter to locate the required report.

3. Locate the report to be submitted and click the icon associated with the report in order to view the available options.

Descriptions of the Action Items

The following table lists and describes the available action items.

Field

Description

View Report

Displays the selected report in a PDF.

Report Details

Enables you to view the report details associated with the report.

Case Summary

Enables you to view a summary of the selected case as shown in the table below.

Local Labeling

Enables you to determine whether labeling has been assessed for the case.

Medical Review

Displays the Medical Review screen of Argus.

The following table describes the meaning of each action item.

Action Item

Description

This report has been scheduled/generated and it is past its due date of submission.

This report has been scheduled and saved.

This report has been scheduled and generated.

This report has been routed and approved by a user.

Case Summary Field Descriptions

The following is an illustration of the Case Summary:

The following table lists and describes the Case Summary fields.

Field

Description

Case Number

Displays the case number

Workflow Status

Displays the workflow status of the case

Initial Receipt Date

Displays the Initial Receipt Date of the case

Days Open

Displays the number of days the case has been opened.
This is calculated by the difference between the Initial Receipt Date and the System Date (Current Date)

Report Type

Displays the Report Type.

Assigned To

Displays the individual that the case was assigned to.

Study ID

Displays the Study ID of the case

Center ID

Displays the Center ID of the case

Sponsor Identifier

Displays the Sponsor Identifier of the case

Randomization #

Displays the Randomization # of the case

Pat. ID

Displays the Patient ID

Initials

Displays the Initials of the patient

Date of Birth

Displays the Date of Birth of the patient

Company Agent Causal

Displays the whether the case was Company Agent Causal or not.

Case Serious

Displays whether the case was serious or not.

Outcome

Displays the outcome of the case.

Listedness Determination

Displays the Listedness status of the case

Products

Displays the Suspect Products associated with the case.

Events

Displays the Events associated with the case.

4. In the Submission Status list of the required report, select Submit.
You can submit multiple reports at a time by selecting Submit for the required reports.

5. Click Process to open the Report Submission Information dialog box.

6. Enter any remarks in Note and click OK.

7. The report(s) opens and a list of submitted reports is generated.

Bulk Reporting

Bulk Reporting enables you to print, transmit and/or submit reports in bulk.

Select Affiliate --> Bulk Reporting to view the Bulk Report screen shown in the following illustration.

Bulk Reporting Filter Section

The Bulk Reporting Filter sections enables you to filter reports.

The following table lists and describes the fields in this section:

Field

Description

Destination

Select an Agency to filter reports by that particular agency. Only the agencies that have reports in the Scheduled, Approved and Generated states are displayed. Click Filter to select multiple agencies from the Reporting Destinations dialog. The previous filtering criteria is saved and retained when the user invokes this dialog. By default, all agencies are assumed.

Report Form

Select any of the listed report forms to view reports belonging to the selected report form only.

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.

Product Family

Enter a Product family to view all cases where the scheduled reports belong to the searched Product family.

Specific Case #

Searches a specific case. To do so, enter the Case Number of the case you wish to search and click the Retrieve button. This stores the agency selections last made.

Total Number of Rows Section

The system displays the search results in the Total Number of Rows section.

It is worth noting that only those reports that are assigned to any LAM groups are listed in Affiliate > Bulk Reporting.

Reports that are unassigned or assigned to Central user group are not listed in Affiliate >Bulk Reporting.

The following table lists and describes the fields and columns in this section.

Field

Description

Selected

Allows the user to select the report.

Lock State

Displays the Case status of the case to depict if the case is locked or un-locked.

Status

Displays the Report Status e.g. Scheduled or Generated etc.
Click the status to view the report details.

Case Number

Displays the Case number.
Click the Case Number link to open the case.

Country of Incidence

Displays the view Country of Incidence.

Report Type

Displays the Case Report Type

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 associated with 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

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 Report form link to view the DRAFT Report as a PDF.

Destination

Displays the report destination (agency) for which the report is scheduled.

Initial / Follow-up (#)

Initial or Follow-up
If Follow-up, the follow-up number is printed

Due Date

Displays the due date.

Days Past Due

Displays the number of days the report is past due date.

Downgrade

Allows the user to view if the report is downgrade.
Displays Yes if the report is a downgrade report else.

Tip:
The icon (displayed in the lock state) in the Affiliate-> Bulk Reporting screen denotes a SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

Printing Options

Several printing options are available to you.

The following table lists and describes the available printing options:

Field

Description

Blind Study Product

Select this check box to print study cases with blinded information.

Mark as Submitted

Select this check box to mark reports as Submitted when the transmission/e-mail has been sent.
A dialog is displayed is this check box is not selected. This dialog prompts you to confirm if the report is to 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.
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.

Suppress Default Printer option in Select Site Printer dialog

While printing reports from the Reports > Bulk Reporting option, if a Site is not selected or left blank, the Default Printer is selected by default under the Printer Name drop-down list.

If a particular Site is selected, the Default Printer option is not listed. By default, the <Select Printer> option is displayed as the first option.

To print Bulk Reports for a particular site, the user can select one of the printers listed for that site from the Printer Name drop-down list and can perform further actions.

User Options

The following options are available to you.

- Lock State Header Options

- Lock State Icon Options

Lock State Header Options

To sort the cases based on the following case status, click the Lock State header row. A pop-up appears listing the following sorting options:

- 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.

Lock State Icon Options

Click the Lock State icon to view the list of options.

The following table describes these 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.

Case Details

Displays the Case Details screen. The tree structure of the case displays only the 'Reports' node, with its existing features.

Medical Review

Displays the Medical Review screen.

Remove Report

Deletes the report from the case on being asked for a justification

Local Labeling

Allows Local Labeling for the selected case.

Mark for Non-Submission

Displays the Submission tab in the Report Details dialog.
Select No for Mark for Non-Submission and enter the reason for the non-submission.

Remove Multiple Reports

Deletes multiple reports from the case on being asked a justification.

View Multiple Reports

Allows you to view multiple reports.

Viewing Report Details

Use the following procedure to view report details.

1. Select Local Affiliate => Report Distribution to open the Report Distribution page.

2. Click the icon associated with the report and select Report Details to open the Report Details dialog box.

3. The Report Details dialog opens.

About the Report Details Dialog Box

The Report Details dialog contains the following tabs:

- General Tab

- Scheduling Tab

- Submission Tab

- Comments Tab

General Tab

The General tab displays the general information about the report. The information on this tab cannot be modified. The following is an illustration of the General tab.

The following tables lists and describes the fields on the General tab.

Field

Description

Agency

Displays the Reporting Destination for which the report is scheduled.

Responsibility

Displays the User Group to which the report is assigned.

Date Generated

Displays the date when the report was generated.

Date Submitted

Displays the date when the report was submitted.

Report Type

Displays the Expedited Report Form of the report.

Language

Displays the language in which the report has been made.

Date Due

Displays the date when the report is due.

Date Transmitted

Displays the date when the report was transmitted.

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.

Scheduling Tab

The Scheduling tab displays a reason for scheduling this report. It also shows the date on which the report was scheduled.

The following tables lists and describes the fields on the Scheduling tab.

Field

Description

Scheduled On

Displays the date when the report was scheduled.

Scheduled By

Displays the name of the person who schedule the report.

Case Revision

Displays the case revision number.

Case Number

Displays the case number.

Reason for Scheduling

Displays the reason for scheduling the report.

Note:
All fields in this tab are auto-populated as per records entered in Argus.

Submission Tab

The Submission tab allows you to specify whether submission is required and enter a reason for not submitting the report.

The following table lists and describes the fields on the Submission tab.

Field

Description

Submission Required

Enables you to select if this report is not required to be submitted to the regulatory authority.

Determined On

Displays the date when the report was considered not required to be submitted.

Determined By

Displays the name of the user who decided the report was not required to be submitted.

Reason for Non-Submission

Click Select to select the reason for non-submission.

Comments Tab

The Comment tab allows you to enter a local comment that prints out on that specific report when generated. Each report has its own respective Local Comment Section.

The following table lists and describes the fields on the Comments tab.

Field

Description

Local Comment

Enables you to enter any remarks about the report.

Viewing Report Submission History

You can view a history of the reports that have been sent from the Report Submission page as shown in the following illustration.

To view Report Submission History

1. Select Local Affiliate -->Report Submission to open the Report Submission page.

2. Select whether you want to view Submitted Reports only or Non-Submit Reports.

3. Enter a custom date range or select an appropriate date range under Range.

4. Click Search. A list of submitted or non-submitted reports appears as per the option you selected.

5. To open a report, click the icon associated with the report and select View Report.

6. To view report details, click the icon associated with the report and select Report Details.
The system submits the report.

To un-submit a report

In the search results for submitted reports, locate the appropriate report.

1. Click the icon associated with the report and select Unsubmit Report to open the Report Unsubmit dialog.

2. This dialog displays the Case Number, Report Name and Submitted status of the selected report.

3. Enter the reason for non-submission of the report in Reason to unsubmit report field and click OK.

Report Submission Tabs

The Report Submission page has the following tabs:

- Submitted Reports

- Non-submitted Reports

The following table lists and describes the fields on the Submitted Reports Only tab.

Submitted Reports Tab

Field

Description

Date Range

Enables you to specify a date range for searching report during a period.
Note: If a Date Range is selected, the From and To fields get populated automatically.

From

Enables you to manually enter the start date for the search period.

To

Enables you to manually enter the last date for a search period.

Action

View Report

Report Details

Unsubmit Report

Local Event Number

Displays the Local Event Number of submitted reports. Click this link to view the case details.

Central Case Number

Displays the Central Case Number of submitted reports.

Destination

Displays the destination of submitted reports.

Report Form

Displays the type of report form for the report. Click this link to view the report in a PDF.

Days Late

Displays the days by which the report had been delayed in its submission.

Submission Date

Displays the date when the report was submitted.

Blind Study Product

Enables you to blind the study product on the Submitted Expedited reports.

Print Submitted Reports

Allows you to print the submitted reports.

Non-Submit Reports tab

The following is an illustration of the Non-Submit Reports tab.

The following tables lists and describes the fields on the Non-Submit Reports tab.

Field

Description

Date Range

Enables you to specify a date range for searching report during a period.
Note: If a Date Range is selected, the From and To fields get populated automatically.

From

Enables you to manually enter the start date for the search period.

To

Enables you to manually enter the last date for a search period.

Action

View Report

Report Details

Enables you with the option of viewing report details.

Local Event Number

Displays the Local Event Number of unsubmitted reports. Click this link to view the case details

Central Case Number

Displays the Central Case Number of unsubmitted reports.

Central Country of Incidence

Enter the country where the adverse event occurred. Enter the partial two-character code, the country name, or the three-character code. Argus Safety will decode the entry. The Administrator can adjust the information in this list.

Destination

Displays the destination of unsubmitted reports.

Report Form

Displays the type of report form for the report. Click this link to view the report in a PDF.

Days Late

Displays the days by which the report had been delayed in its non-submission.

Non-Submit Date

Displays the date when the report was not submitted.

Changing Your Password

The Change Password utility enables you to change your password as necessary. When you log on to the system for the first time, it is recommended that you change your password.

To change your password:

1. Select Utilities => Change Password from the Utilities menu.

2. When the system opens Change Password dialog box:

- Enter your current password in the Old Password field.

- Enter the new password in the New Password field.

- Enter the new password a second time in the Confirm Password field.

3. Click OK.
The system changes your password.

3 Central Users

This chapter includes the following sections:

- About Central Users

- Viewing the Worklist

- Reviewing Incoming Events

- Searching for Duplicates

- Accepting Local Events

- Rejecting Local Events

- Encoding Events

- Locking Cases

- Entering Follow-up Information

- Viewing Affiliate Report Submission

- Medical Review

About Central Users

This chapter describes the tasks that can be performed by the Central Users of Argus Affiliate. Unless you are an Enterprise Workflow Manager, you are limited to events you can access from the following dialog boxes:

- Local Affiliate --> Worklist --> Pending Local Labeling

- Local Affiliate --> Worklist --> Cases in Pending Central Actions

- Local Affiliate --> Worklist --> Not Routed cases

If you are an Enterprise Workflow Manager, you can view all cases across multiple sites.

Note:
Central users must log on to Argus Safety Web in order to perform the activities that are related to local affiliates.

Viewing the Worklist

In the Argus User Interface, select Worklist from the Local Affiliate Menu to access the different options available through this screen. The Worklist screen appears as shown:

The following table lists and describes each of the tabs on this screen.

Field

Description

Pending Central Actions

Displays actions on local events that are pending at central

Not Routed

Displays local events that have not yet been routed to central

Cases Pending Local Labeling

Displays pending action items that have been assigned to the Local Affiliate Users.

Action Items from Local

Displays the list of action items pending from Local.

Action Items from Central

Displays the list of action items pending from Central.

Intake Worklist

Displays the list of cases present in the Intake queue.

Pending Central Actions Tab

The following is an illustration of the Pending Central Actions tab.

The following table lists and describes the fields on the Pending Central Actions tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Central Case Number

Displays the central case number.

Central Workflow State

Displays the current workflow state of the Central Case.

Actions/Routing Comments

Displays any actions or routing comments for the case.

Print List

Prints the list displayed in the screen in a PDF.

Not Routed Tab

The following is an illustration of the Not Routed tab.

The following table lists and describes the fields on the Not Routed tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Primary Suspect Product

Displays the name of the primary suspect product.

Primary Event

Displays the name of the primary event.

Route to Central

On selecting LAM Event(s) and clicking the Route to Central button, the system displays the Routing Confirmation dialog followed by the Route to Central dialog to confirm the routing of LAM Events to Central.

Country of Incidence

Displays the country where the adverse event occurred.

Local Affiliate Name

Displays the name of the local affiliate.

Print List

Prints the list displayed in the screen in a PDF.

Action Items from Local

The following is an illustration of the Action Items from Local tab.

The following table lists and describes the fields on the Action Items from Local tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Central Case Number

Displays the case number with Central.

Central Workflow State

Displays the workflow state of the case.

Action Items

Displays a description of the action to be taken up for the LAM event.

Due Date

Displays the due date for the action item.

Print List

Displays the option to print the list.

Action Items from Central

The following is an illustration of the Action Items from Central tab.

The following table lists and describes the fields on the Action Items from Central tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Central Case Number

Displays the case number with Central.

Central Workflow State

Displays the workflow state of the case.

Action Item Code

Displays a code of the action to be taken up for the LAM event.

Date Open

Displays the date since when the action has been due.

Description

Displays the description of the action.

Due Date

Displays the due date for the action item.

Completed

Displays the date by when the action item will be completed.

Print List

Displays the option to print the list.

Cases Pending Local Labeling Tab

The following is an illustration of the Cases Pending Local Labeling tab.

The following table lists and describes the fields on the Cases Pending Local Labeling tab.

Field

Description

Local Event Number

Displays the local event number. The link displayed in this field helps you in viewing event information.

Primary Suspect Product

Displays the name of the primary suspect product.

Central Case Number

Displays the case number with Central.

Primary Event

Displays the name of the primary event.

Country of Incidence

Displays the country where the adverse event occurred.

Local Affiliate Name

Displays the name of the local affiliate.

Intake Worklist

The following is an illustration of the Intake Worklist - Pending tab.

The following table lists and describes the fields on the Intake Worklist - Pending tab.

Field

Description

Priority

Allows the user to view the priority of the case.

Initial Date

Allows the user to view the initial receipt date of the case.

Intake Date

Allows the user to view the date the system imported the attachment within the Intake Worklist.

Product Name

Allows the user to view the Suspect Product in question.

Generic Name

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

Event PT

Allows the user to view the Primary Event and Verbatim as Reported.

Event Verbatim

The following format will be used:Primary Event (Verbatim as Reported)

Serious

Allows the user to view the case-level assessments.

F, LT or H

Displays the status as Fatal (F) or Life-Threatening (LT) or Hospitalized (H). If the case is neither of the above, it displays 'No'.

Case Type

Allows the user to view the report type information.

Study ID

Allows the user to view the Study ID of the study cases. For cases where the Study ID is not present, this field is empty.

Reporter Type

Allows the user to view the Reporter Type of the study cases. For cases where the Reporter Type is not present, this field is empty.

Country

Allows the user to view the country of incident.

Central / LAM Site

Allows the user to view the current site (Argus or Affiliate) of the case.

Attachment

Allows the user to view the attachment which is associated to the case. If there are multiple files, these shall be separated by a comma.

Classification

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

Description

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

Status Details

Allows the user to view the details of the status associated to the case.

Accept/Reject Local Event

Allows the user to accept/reject the Local Event associated to the case.

Print List

Allows the user to print the list of cases displayed on this screen.

The following is an illustration of the Intake Worklist - Rejected tab.

The following table lists and describes the fields on the Intake Worklist - Rejected tab.

Field

Description

Priority

Allows the user to view the priority of the case.

Initial Date

Allows the user to view the initial receipt date of the case.

Intake Date

Allows the user to view the date the system imported the attachment within the Intake Worklist.

Product Name

Allows the user to view the Suspect Product in question.

Generic Name

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

Event PT

Allows the user to view the Primary Event and Verbatim as Reported.

Event Verbatim

The following format will be used:Primary Event (Verbatim as Reported)

Serious

Allows the user to view the case-level assessments.

F, LT or H

Displays the status as Fatal (F) or Life-Threatening (LT) or Hospitalized (H). If the case is neither of the above, it displays 'No'.

Case Type

Allows the user to view the report type information.

Study ID

Allows the user to view the Study ID of the study cases. For cases where the Study ID is not present, this field is empty.

Reporter Type

Allows the user to view the Reporter Type of the study cases. For cases where the Reporter Type is not present, this field is empty.

Country

Allows the user to view the country of incident.

Central / LAM Site

Allows the user to view the current site (Argus or Affiliate) of the case.

Attachment

Allows the user to view the attachment which is associated to the case. If there are multiple files, these shall be separated by a comma.

Classification

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

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.

Rejected By

Allows the user to view the name of the user who rejected the case.

Status Details

Allows the user to view the details of the status associated to the case.

Accept/Reject Local Event

Allows the user to accept/reject the Local Event associated to the case.

Print List

Allows the user to print the list of cases displayed on this screen.

Reviewing Incoming Events

You can review incoming events from the Incoming Review page. The page has two tabs:

- Initial

- Follow-up

To review incoming events

1. Select Local Affiliate > Incoming Review to open the Incoming Review page.

2. The system opens the Initial tab by default. On this tab you can review new incoming events.

The following table describes the fields on the Initial tab.

Field

Description

#

Displays the serial number of each search result.

Action

Enables you to perform an action item.

Central Case Number

Displays the central case number of the event.

Local Tracking Number

Displays the local tracking number of incoming events. Click the link displaying the local tracking number to view the follow-up information.

Receipt Date

Displays the date when the incoming events was received.

Local Affiliate Name

Displays the name of the local affiliate.

Primary Suspect Product

Displays the name of the product that is most likely to have caused the adverse event.

Primary Event

Displays the name of the primary event.

Country of Incidence

Displays the name of the country where the adverse event occurred.

Patient Initials

Displays the initials of the patient.

Print List

Displays the list of follow-up events in a PDF.

3. If you wish to review follow-up events or information click the Follow-up tab.

The following table lists and describes the fields on the Follow-up tab.

Field

Description

#

Displays the serial number of each search result.

Action

Enables you to perform an action item.

Central Case Number

Displays the central case number of the event.

Local Tracking Number

Displays the local tracking number of incoming events. Click the link displaying the local tracking number to view the follow-up information.

Receipt Date

Displays the date when the incoming events was received.

Local Affiliate Name

Displays the name of the local affiliate.

Primary Suspect Product

Displays the name of the product that is most likely to have caused the adverse event.

Primary Event

Displays the name of the primary event.

Country of Incidence

Displays the name of the country where the adverse event occurred.

Patient Initials

Displays the initials of the patient.

Print List

Displays the list of follow-up events in a PDF.

4. Under Local Affiliate, select the local affiliate whose events are to be reviewed.

5. Click Search. A list of matching search results is displayed.
The following table lists the columns that appear in search results:

Initial Events

Follow-up

Local Tracking Number

Central Case Number

Receipt Date

Local Tracking Number

Local Affiliate Name

Receipt Date

Primary Suspect Product

Local Affiliate Name

Country of Incidence

Primary Suspect Product

Primary Event

Country of Incidence

Patient Initials

Primary Event

Patient Initials

6. To view the incoming event or follow-up information, click the link associated with the Local Tracking Number. The following review screen is displayed.

The event information viewed from here cannot be modified.

Tip:
You can accept follow-up information, and accept or reject local events, from the list of incoming events.

Searching for Duplicates

When performing a duplicate search, be aware of the following:

- You can perform a duplicate search for incoming follow-up cases.

- When you click the Duplicate Search dialog, the system performs a duplicate search on the selected case.

- The user can search a maximum of 1000 cases.

- The system performs the duplicate search in the same way it performs the Central AE Bookin Dialog Dup search.

- The system runs the duplicate search against cases in the Central AE database.

- The Receipt Range Limits checkbox enables the user to restrict the search to the last 3 months. If the checkbox is unchecked, the system runs the search against all cases.

- The Select All and Deselect All buttons allow all the checkboxes associated with the Search fields to be checked/unchecked (respectively) in Duplicate Search.

- The system uses the Oracle Text profile settings for the duplicate search in Affiliate.

To search for duplicates

1. Review incoming events from Local Affiliates.

2. Click the icon associated with the required case and select Duplicate Search.

3. The Argus Safety Duplicate Search dialog opens.

4. Select the check boxes associated with the items by which the duplicate search is to be executed. Clear the check boxes that are not to be considered for duplicate search.

5. Click Search. A list of search results matching the specified search criteria is displayed.
Inspect the search results to determine if the event is already associated with a previously entered case.

Accepting Local Events

On reviewing incoming events, you can accept an event that was routed by a local affiliate.

To accept local events:

1. Before accepting an event, search for duplicates to check if a similar event is not associated with a case at Central.

2. Click the icon associated with the incoming event and select Accept Local Event.

3. If the system is configured for manual numbering of cases, enter the Case ID Number and click OK.

4. If the system is configured for automatic numbering of cases, a Case ID Number is automatically allotted to the case.

5. In the Accept Local Event dialog, click OK.

6. When the case is accepted, the Accept icon appears next to the case.

Accepting Events for Initial Cases

You can select the fields that need updating after clicking Accept Local Event. The following is an illustration of the Incoming Review page.

Be aware of the following when accepting local events:

- After you accept the local event, the system displays the Affiliate Acceptance dialog box.

- By default, the system checks all the elements for the affiliate event so they will be accepted in Argus Central.

- If an element does not have any data, the system does not display it.

- The field labels are configured in the same manner as the field labels in the Central Case Form fields in the Console.

- If the section is checked, all child elements are checked.

- You can check or uncheck individual entities.

- The system does not enable the Accept Case button until the following fields contain data:

- Initial Receipt Date

- Country of Incidence

- Report Type

- Any single Product Name Information

- Any Single Event Verbatim

- When you click Accept Initial, the system displays the Justification dialog for acceptance.

- When you click Reject Initial, the system rejects the affiliate event.

Accepting Events for Follow-up Cases

When accepting events for follow-up cases, be aware of the following:

- In the Affiliate Acceptance dialog box, you can select the fields that need to be updated in the Argus Central case.

- By default, the system checks all the elements for the affiliate event to be accepted in Argus Central.

- The acceptance order is the same as the order defined in the Argus Case and the affiliate event for multiple entities (e.g., Products/Events/Reporters are compared against as entered in Argus Safety case and Affiliate case).

- The system displays the elements for deleted entities in red.

- The system displays the elements for updated entities in yellow.

- The system displays the elements for added entities in grey.

- The system displays the affiliate field labels in the Acceptance dialog.

- The number of follow-ups are the total number of follow-ups in the affiliate event.

- When you click Accept Follow-up, the system displays the Justification dialog for acceptance.

- When you click Reject Follow-up, the system rejects the follow-up affiliate event.

- The system attaches the difference report to the case after you accept the Argus Affiliate event.

Entering Follow-up Information

When you review incoming events, you can update a case with the follow-up information routed by the local affiliate.

To enter follow-up information:

1. Click the icon associated with the incoming event and select Accept Follow-up.

2. The follow-up information appears in a new window in PDF format.

3. Review the follow-up information in the follow-up report. You can then make the appropriate changes to the case information from the Argus Safety Case Form.

Note:
The follow-up information appears in the Additional Info tab of the Case Form

4. Refer to the Argus Safety User's Guide for further information on entering case information on the Case Form.

Accepting Follow-ups from Affiliate for Archived Cases

You can accept follow-up for an archived case. Use the following procedure to do so.

To accept a follow-up for an archived case:

1. Enter the password and required notes, to reopen the case from the Archived Case dialog.

2. If you are able to unarchive the case successfully, the standard routing dialog is displayed.

3. The system auto-populates the "Current State" field with the state it was archived from (such as Work in Progress).

4. The system auto-populates other values in the Routing dialog based on the current state following the normal or current functionality of the Routing dialog.

Accepting Follow-ups from Affiliate for Locked Cases

You can accept follow-up for locked case. Use the following procedure to do so.

To accept a follow-up for a locked case:

1. Enter the password and required notes, to unlock the case from the Locked Case dialog.

2. If the case is unlocked successfully, the system opens the standard routing dialog. The Current field is auto-populated in this dialog with the state it was currently in.
The other values in this dialog can also be auto-populated based on the current state.

Accepting Follow-ups for Open Cases

The preceding functionality of the Current State is the same for accepting follow-ups for open cases. In all scenarios, the last follow-up date entered in Argus Affiliate is auto-populated in the Argus accepted case.

An Argus Affiliate Follow-up case is identified by a red exclamation mark in the Worklist > New section of Argus Safety.

This icon is cleared automatically after the case is routed.

Rejecting Local Events

On reviewing incoming events, you can reject an event that was routed by a local affiliate.

To reject local events:

1. Click the icon associated with the incoming event and select Reject Local Event.

2. Enter a justification for rejecting the event in the Action Justification dialog box and click OK.

3. In the Reject Local Event dialog, click OK.

4. When the case is rejected, the Reject icon appears adjacent to the case.

5. When the case is rejected, the action item is displayed within LAM Worklist - LAM Action Items from Central in both Initial and Follow-up rejection scenarios, with the following attributes:

Initial Events

Follow-up

Date

The local date of the person rejecting the case

Action Item Code

The action item code that can be configured through List Maintenance.

Action Item Description

"Case rejected by central due to" followed by the notes/reason entered by the Argus Affiliate acceptor.

Responsible User

Set to "any".

Due Date

The due date, which is populated automatically.

Encoding Events

After a case related to the local event is created in Argus Safety, the events for the case must be encoded.

Refer to Argus Safety Web User's Guide for information on encoding events.

Locking Cases

After the events for a case are encoded, the case can be locked so that local labeling can be performed by the Affiliate Users.

Refer to the Argus Safety Web User's Guide for instructions on locking a case.

Viewing Affiliate Report Submission

Use the following procedure to view affiliate report submissions.

To submit a report:

1. Select Report Submission from the Local Affiliate menu to open the Report Submission page.

2. Select whether you want to view Submitted Reports only or Non-Submit Reports or reports that are Pending Submission.

3. Enter a custom date range or select an appropriate date range under Range.

4. Click Search. A list of submitted or non-submitted reports appears as per the option you selected.

5. To view report details, click the icon associated with the report and select Report Details.

6. To open a report, click the icon associated with the report and select View Report.

About the Report Submission Page

The Report Submission page has three tabs as follows:

- Submitted Reports Only Tab

- Non-Submit Reports Tab

- Pending Submission Tab

Submitted Reports Only Tab

The following is an illustration of the Submitted Reports Only tab.

The following table lists and describes the fields on the Submitted Reports Only tab

Field

Description

Local Affiliate

Enables you to select the local affiliate to be viewed.

Date Range

Enables you to specify a date range for searching report during a period.
Note: If a Date Range is selected, the From and To fields get populated automatically.

From

Enables you to manually enter the start date for the search period.

To

Enables you to manually enter the last date for a search period.

Action

View Report

Report Details

Enables you with the option of viewing report details.

Unsubmit Report

Enables you to un-submit the selected reports.

Local Event Number

Displays the Local Event Number of submitted reports. Click this link to view the report in a PDF.

Central Case Number

Displays the Central Case Number of submitted reports.

Central Country of Incidence

Enter the country where the adverse event occurred. Enter the partial two-character code, the country name, or the three-character code. Argus Safety will decode the entry. The Administrator can adjust the information in this list.

Destination

Displays the destination of submitted reports.

Report Form

Displays the type of report form for the report. Click this link to view the report in a PDF.

Days Late

Displays the days by which the report had been delayed in its submission.

Submission Date

Displays the date when the report was submitted.

Blind Study Product

Enables you to blind the study product on the Submitted Expedited reports.

Print Submitted Reports

Enables you to print the submitted reports.

Non-Submit Reports Tab

The following is an illustration of the Non-Submit Reports tab.

The following table lists and describes the fields on the Non-Submit Reports tab.

Field

Description

Local Affiliate

Enables you to select the local affiliate to be viewed.

Date Range

Enables you to specify a date range for searching report during a period.
Note: If a Date Range is selected, the From and To fields get populated automatically.

From

Enables you to manually enter the start date for the search period.

To

Enables you to manually enter the last date for a search period.

Action

View Report

Report Details

Enables you with the option of viewing report details.

Local Event Number

Displays the Local Event Number of unsubmitted reports. Click this link to view the report in a PDF.

Central Case Number

Displays the Central Case Number of unsubmitted reports.

Central Country of Incidence

Enter the country where the adverse event occurred. Enter the partial two-character code, the country name, or the three-character code. Argus Safety will decode the entry. The Administrator can adjust the information in this list.

Destination

Displays the destination of unsubmitted reports.

Report Form

Displays the type of report form for the report. Click this link to view the report in a PDF.

Days Late

Displays the days by which the report had been delayed in its non-submission.

Non-Submission Date

Displays the date when the report was not submitted.

Pending Submission Tab

The following is an illustration of the Pending Submission tab.

The following table lists and describes the fields on the Pending Submission tab.

Field

Description

Local Affiliate

Enables you to select the local affiliate to be viewed.

Date Range

Enables you to specify a date range for searching report during a period.
Note: If a Date Range is selected, the From and To fields get populated automatically.

From

Enables you to manually enter the start date for the search period.

To

Enables you to manually enter the last date for a search period.

Action

View Report

View Draft Report

Enables you to view the draft report.

Report Details

Enables you with the option of viewing report details.

Local Event Number

Displays the Local Event Number of unsubmitted reports. Click this link to view the report in a PDF.

Central Case Number

Displays the Central Case Number of unsubmitted reports.

Central Country of Incidence

Enter the country where the adverse event occurred. Enter the partial two-character code, the country name, or the three-character code. Argus Safety will decode the entry. The Administrator can adjust the information in this list.

Destination

Displays the destination of unsubmitted reports.

Report Form

Displays the type of report form for the report. Click this link to view the report in a PDF.

Days Late

Displays the days by which the report had been delayed in its non-submission.

Submission Date

Displays the date when the report was due for submission.

Medical Review

Use the Medical Review function to quickly and efficiently view important information in a case. The following is an illustration of the Medical Review screen.

Note:
The Medical Review section from Local Affiliate Module is a read-only section. You can view the information related to a case but cannot edit it from the Argus Affiliate's Medical Review.

To Access Medical Review:

1. Select Case Actions -- > Medical Review to open the Medical Review screen.

2. The system opens the Medical Review screen.

Common Features in Medical Review

The following table lists and describes the common features under Medical Review.

Field

Description

Generate

Click Generate in either of the narrative fields to enable Auto Narrative Generation.

Return Case

Click Return Case to open the return route dialog and save the information.

Forward Case

Click Forward Case to open the forward route dialog and save the information.
When the case has been routed and the form is closed, you cannot route from the case form Activities tab till the case has been closed and re-opened.

View Draft

Select a report and click View Draft to generate a draft version of the report based on the open case.
Note: This report form type is saved as a default and the next time the user opens the Medical Review for another case, this is defaulted to the Report Form selected previously.

The Draft report does not display all the changes made to the Case until the case has been saved in the database.

Zoom/un-zoom icon

Click the zoom icon to view the selected dialog on a much bigger scale.
Click Un-Zoom icon to revert back to the earlier view.

About Medical Review

Medical Review contains 3 sections:

- Case Narrative Section

- Case Assessment

- Event Assessment

Enter information in the Case Narrative, Case Assessment and Event Assessment sections.

Note:
An (S) is displayed for Serious events.
An (F) is displayed for Fatal events.

An (LT) is displayed for Life Threatening events.

An (H) is displayed for Hospitalized events.

Case Narrative Section

The Case Narrative section is read-only and cannot be changed.

However, you can choose from the drop down options in other fields to view any of the other narrative fields.

This view is saved as a default and the next time the user opens the Medical Review for another case, this is defaulted to the narrative fields selected previously.

You cannot choose the same Narrative field in the drop down options available. The first selected narrative field is disabled in the second drop down option.

Case Assessment

The Case Assessment section assesses the case details.

Select whether the case is serious or not from the Case Serious drop-down list.

Similarly, select relevant information about Company Agent Causal, Listedness and Outcome from the drop-down lists.

Event Assessment

The Event Assessment section enables you to understand more about the events.

The following table lists and describes the fields in the Event Assessment section.

Field

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.

Event

This field is populated when events are entered in the Events tab and is displayed in the following format:
• First Line - Event PT

• Second Line - Verbatim

• Third Line - LLT

Products

This field is populated when events are entered in the Products tab and is displayed in the following format:
• First Line - Product Name

• Second Line - Generic Name

Datasheet

Displays the datasheet(s) for the agent

License

Displays the license(s) for the agent

Reported Causality

Indicates the degree of reported causality.

Determined Causality

This field is populated automatically, along with the information entered in the Reported Causality field.

Determined Listedness

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

D/S

Displays the Diagnosis/Symptom details by D or S in line with the Events

Seriousness Severity Duration

Display the Seriousness, Severity and the Duration of the Event.

Filtering in the Event Assessment Section

The following table describes how each field of the Event Assessment screen is filtered.

Field

Description

Product

The product filter drop down list contains all products listed in the event assessment. The user can filter on all the products which are present in the Event Assessment dialog.

Event

Contains a drop down of values of distinct Event PT. The user can filter on all the products which are present in the Event Assessment dialog.

Diagnosis

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

Datasheet

Contains a drop down of values of distinct Datasheets. All the blank datasheets shall be displayed as a single row of <Unspecified>

Licenses

Contains a drop down of values of distinct Countries of the Licenses. All the Licenses which are not associated to a Datasheet shall be displayed under <Unspecified> else aligned with the Datasheet view.

Note:
Only the assessment rows that match the selected criteria are displayed in the filtering results.

User Actions within Event Assessment

The following tables describes user actions and their results.

Field

Description

Click the Datasheet column's "plus" icon

Displays the license and datasheet views and displays the License Column and enable the "-" for the License Column.

Click Product Name

Displays the Product Information dialog for the selected product

Click Event Description

Displays the Event Information dialog for the selected event

Click License Description

Displays the Product Information as defined in the License Configuration

Click Datasheet Description

Displays all the configured terms in the datasheet

About Temporal View

Click Temporal View to view a read-only version of the case before routing.

The information displayed in the Temporal View tab is taken from the information entered in the Case Form section.

Temporal View Fields: Summary Section

The following is an illustration of the Summary section of the Temporal View tab.

The following table lists and describes the fields in the Summary section.

Field

Description

Primary Suspect Product

Displays the name of the primary suspect product

Generic Name

Displays the generic name of the primary suspect product

Indication

Displays information about the product indication.

Patient Gender

Displays the gender of the patient.

Patient Age

Displays the age of the patient

Report Type

Displays the report type.

Reporter Type

Displays the type of reporter reporting the event

Company Diagnosis

Displays the company diagnosis

Case Serious

Displays whether the case is serious or not

Case Causality

Displays the case causality status

Temporal View Fields: Displays Options Section

The following table lists and describes the fields in the Display Options section.

Field

Description

Suspect Products

Select the checkbox to view Suspect Products in the Event Assessment Section

Non-Suspect Products

Select the checkbox to view Non-Suspect Products in the Event Assessment Section

Patient History

Select the checkbox to view Patient History in the Event Assessment Section

Patient Lab Data

Select the checkbox to view Patient Lab Data in the Event Assessment Section

Relevant Tests

Select the checkbox to view Relevant Tests in the Event Assessment Section

Events - All Events, Serious Events Only

Select the checkbox as required to view All Events/Serious Events Only in the Event Assessment Section

Temporal View Fields: Event Assessment Section

The following is an illustration of the Event Assessment section of the Temporal View tab.

The following table lists and describes the fields in the Event Assessment section.

Field

Description

Time Scale

Displays the time period pertaining to the event assessment like weekly, monthly, etc.

ID

Denotes the type of event. For example, HOSP means Hospitalized

Info

Click the Info icon (i) to view details about the selected entity.

Item

Displays the item name

Start

Displays the date from when the event assessment began

Stop

Displays the last date of the event assessment

Duration

Displays the duration of the event assessment

Temporal View Fields: Relevant Tests Section

The following table lists and describes the fields in the Relevant Tests section.

Field

Description

Notes

Displays the notes entered, if any

Zoom/Un-zoom icon

Click the Zoom icon to view the report on a bigger scale.
Click the Unzoom icon to revert to the earlier view

Flag icon

This icon displays the language text that is supported

Notes icon

Click this icon to view/enter notes.

Save and Close

Closes the dialog, saving any changes

About Action Items

The following is an illustration of the Action Items tab.

The following table lists and describes the fields on the Action Items tab.

Field

Description

Date Open

Enter the date the action item was created. Open action items appear in the Worklist of the user who is responsible for the action item. They also appear in the Open Action Items Report.

Code

Select an Action Item code from the drop-down list. This will display the description of the selected Action Item Code. The Administrator can adjust this list.

Description

Selecting an Action Item code automatically enters information into this field. The text can be modified as required. The Administrator can adjust this list.

Group/User

Select a group responsible for the Action Item from the given drop-down list. From the drop-down list below this, select a user from the selected group who will be responsible for the action. The Action Item will appear in the Worklist for the selected user. If "Any" is chosen as the group, the Action Item appears in all the users' Worklist. The Administrator can adjust these lists.

Due

Enter the date on which the action item is to be completed.

Completed

Enter the date on which the action item was completed.

4 Affiliate Configuration

The Affiliate Administrator is responsible for configuring the Argus Affiliate. This section includes discussions of configuration tasks.

Creating User Groups

Each Argus Safety user can be a member of one or more user groups. The access rights of each user group to the menus in the user interface and specific sections of the Case Form can be configured when the group is created.

The Administrator can configure user groups from Argus Console >Access Management >Argus > Groups. Because user group configuration can only be done from Argus Safety application, the Administrator must be logged on to Argus Safety application.

The following is an illustration of the Groups and Users page.

This section enables the Administrator to configure the security levels for each work group.

Radio buttons enable you to view the group and assign access rights for several specific sections of the case form, menu, case workflow, and report workflow.

Tip:
If a user belongs to multiple groups, the access rights for the user will be the sum-total of the individual group access rights.
Example: John Smith is an Argus User and his profile has been added to 2 user-groups with different access level permissions for each group. John has access rights to the Patient Tab in one group and access rights to the General Tab in another group. In this case, John will be able to access both the Patient and the General tabs of Argus.

To add/copy/modify/delete user groups navigate to the Access Management->Argus->Groups section.

The following table lists and describes the fields on the Groups and Users page.

Field

Purpose

Group Name

Enables the administrator to enter a unique name for the group

Email

Enables the administrator to add the group email, used for case priority notification and workflow routing notification

Supervisor Email

Enables the administrator to add the Group's Supervisor Email as applicable. This e-mail address is used to send notifications when the maximum time of a case for a particular workflow state is exceeded

Case Form

Lists the different sections and sub sections within a Case Form and enables the Administrator to assign the group Modify; View (Read Only); or No Access Rights (not visible) to each area

Menus

Lists the different menus and sub menus within a Case Form and enables the Administrator to enable or disable each of them

Advanced conditions -- No create Advanced Condition Access

If No Create Advance Condition Access is checked, then the Advance Condition will not appear as an option for any user belonging to the group

Advanced conditions -- No access to share Advanced conditions

If No Access to Share Advance Conditions is checked then any user belonging to the group, will not be able to share the Advance Conditions with others

Advanced conditions -- No Access to view & edit SQL

If No Access to View and Edit SQL is checked, then the SQL button will not appear for the user belonging to the group

Listedness Determination -- Countries

Enables the administrator to assign Argus users to the group that has the rights to change the listedness determination for licenses originating in the selected countries

Restrictions - Products

Product security limits the number of products that can be viewed in the trade name lookup and non-study cases
Click the Products checkbox to enable the Select button

Click this button to view a security configuration containing a tree view list of available items

Select a product family to select all its constituents

Restrictions - Studies

Study security limits the number of studies available for selection and the study cases that can be viewed
Click the Studies checkbox to enable the Select button

Click this button to view a security configuration containing a tree view list of available items

Select a study family to select all its constituents

Default report (Argus Affiliate only)

This field lists the expedited report forms in the drop-down list

To Create a User Group

1. In the Access Management menu, click Argus > Groups.

2. Select the filtering criterion. The left panel now displays the list of Groups or Users based on the filtering criterion.

The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Access Management section.

Using Organized By

The filtering browser is displayed in the top-left corner of the left panel. This section can be filtered on the basis of any of the two combinations displayed below.

For Example: If you enable Organized by Groups, then the output generated will be visible in a tree-format, in the left panel, based on the entire categorization of Groups and Users

Whereas if you enable the Organized by Users, then only the User list will be available in the tree view in the left panel.

Using the "contains" or "starts with" characters enables you can specify whether your search should contain or start with specific characters.

For example, the filtering criterion defined above will search for all Groups that contain the word "administrator".

1. Select a Group and click to view the group details in the right panel.

Tip:
Select a group under LOCAL AFFILIATE in the left panel to view the details of a Argus Affiliate Group.
You can alternatively click Add Group to create a new group.

Use Copy to make an editable copy of an existing group.

Use Delete to delete a group.

2. Enter the Group Name. This should be a unique name associated with this Group.

3. Enter the Email address, if applicable.

4. Enter the Supervisor Email address, if applicable.

5. In the Case Form section, select the desired access right option ("Modify", "View", or "No Access") for the group's access to each of the listed items of Case Form.

Caution:
The following fields are required in order to save a case: Initial Receipt Date, Country of Incidence, Report Type, Suspect Product, and Event Description as Reported. Therefore, the group responsible for initial case entry must have access to these fields in order to save new cases.

6. In the Menus section, enable or disable access of the group, to particular items in the Argus Safety menu.

Tip:
Refer to the Argus Safety User Guide for information about the functions of the Case Form sections and the menu items in the Argus Safety user interface.

7. In the Listedness Determination section, select a list of countries. This enables the end user to override the listedness determination in the Event Assessment section of the Case Form for product licenses that match the countries selected in this step.

8. In the Advanced Conditions section, select No Create Advanced Condition Access, No Access to Share Advanced Conditions, and/or No Access to View and Edit SQL.

Tip:
If you select the No Create Advanced Condition Access checkbox, the Advanced Conditions button will not appear as an option for that user group.
If you select the No Access to Share Advanced Conditions checkbox, the user group will not have access to share Advanced Conditions.

If you select the No Access to View and Edit SQL checkbox, the SQL... button will not appear as an option for that user group.

9. In the Restrictions section, select Products.
If you click Add Product, the following screen appears. Mark the products required by selecting the check box and click OK.

10. In the Restrictions section, select Study.

11. If you click Add Study, the following dialog appears. Mark the studies required by selecting the check box, and click OK.

12. Click Save or Add Group to save the newly created Argus Affiliate group.
The following table lists and describes the Groups included with factory data:

Group

Description

Administrator

This group has access rights to all areas and all the functionality of Argus Safety.

Investigator

Receives an e-mail alert that can be set up during Clinical Study Configuration.

Creating User Accounts

The User Maintenance dialog enables the Administrator to add, copy, or delete users for the system.

Each user must be assigned to at least one group in order to determine their security level. Each group is assigned a specific security level, allowing members of the group view, modify, or have no access rights to various sections of the case form, etc.

Configuration of the users is done from Argus Console > Access Management > Argus > Users.

The following illustration shows the fields associated with this section.

Field Descriptions

The following table lists and describes the fields in the Administrator section

Field/Control Name

Description

User Name

Enter the full name.

User ID

Enter a unique user identification (ID).

Reset Password

Reset the password of a user to a default value specified in the common profile section.

Email Address

Enter the user's e-mail address.

Site

Assigns the user to a site.
The values in this field are populated from the codelist item User Sites.

User Group - Select

Attaches the user to pre-configured user groups.

User Type

Select the type of user, such as an Argus J user from the drop-down list.

Application Access

Configure user access settings for Argus Console and Argus Safety.
The default application access for the user can be selected from the list.

Worklist to display at login

Configure users to see their worklists immediately upon login. The options are:

- None (default) - Does not open any worklist when the user logs into Argus. Displays personal Argus status on login.

- Action Items - Opens Worklist - Action Items screen for the user on login into Argus

- New - Opens Worklist - New screen for the user on login into Argus

- Open - Opens Worklist - Open screen for the user on login to Argus.

- Reports - Opens Worklist - Reports screen for the user on login into Argus

Enable site security

If Enable Security is checked, the site-based data security will be enabled for the user.
If the box is not checked, the user will have full access to data from all sites.

Enable LDAP Login

Authenticates users against the active directory server.
When Enable LDAP Login is selected, all fields inside the Access section are disabled, excluding the Account Disabled option.

Account Disabled

When this option is selected, the user account is temporarily disabled to prevent users from logging in. This option is different from deleting a user as it enables the Administrator to re-activate the account at a later date.

Security Disabled Account

- When unchecked, the login procedure keeps track of the number of consecutive unsuccessful attempts at logging into the system. If the count reaches three, the login procedure will always fail the password validation to lock the user out. Administrators with rights to user maintenance can reset the login attempts for the user to unlock the account.

- When checked, the login procedure that tracks the consecutive unsuccessful attempts at logging into the system do not apply.

Force password change at login

If this check box is selected, the users must change the password the first time user logs on to the system after the checkbox is checked.

Force password to expire every

Enables the Administrator to force the user's password to expire in the specified number of days.

Days

Enables the Administrator to enter the number of days after which the password should expire.

__ Days remaining

The field displays the number of days remaining for the password change.

Allow unblinding of cases

Enables the user to unblind a study case.
For example, a user without unblinding rights will not see the Study Drug field. A user with unblinding rights sees a yellow Unblind tag next to concentration of product field and the Broken by Sponsor option in Blinding Status drop-down list is enabled. User will have to enter password when user selects Broken by Sponsor' option.

Protect from unblinded information

When checked, the user cannot view any unblinded information.

Protect from printing unblinded information

When checked, the user cannot print any unblinded information.

Allow locking of cases

Enables the user, to lock/unlock the cases.

Allow closing of cases

Enables the user to close the cases.

Route on close case

Opens a routing dialog when the user closes the case.

Enable Checklist on Route

By default, this checkbox is selected.
If this checkbox is not selected, the checklist for the Workflow is not displayed to the user while routing the cases, even if the rule that is being used has a checklist.

Adding Users

This section enables you to add, copy, modify or delete users for the system. When managing user accounts, be aware of the following:

- Each Argus user must be assigned to at least one group in order to determine the user's security level.

- Each group is assigned a specific security level. This enables group members to view/modify or have limited access rights to various sections of the case form, etc.

- To add/copy/modify/delete users navigate to Argus Console>Access Management->Argus->Users section.

To Create a User Group

1. In the Access Management menu, click Argus > Users.

2. Select the filtering criterion. The left panel now displays the list of Groups or Users based on the filtering criterion.

The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Access Management section.

Using Organized By

The filtering browser is in the top-left corner of the left panel. This section can be filtered on the basis of any of the two combinations displayed below.

For example, if you enable Organized by Groups, the generated data will be visible in a tree-format, in the left panel, based on the entire categorization of Groups and Users

Whereas if you enable the Organized by Users, then only the User list will be available in the tree view in the left panel.

Using the contains or starts with you can specify whether your search should contain or start with specific alphabets.

For example, the filtering criterion defined above will search for all Users that contain the word "admin".

1. Select a User and click to view the user details in the right panel.

Note:
You can alternatively click Add User or Add New User to create a new user.
Use Copy to make an editable copy of an existing user.

Use Delete to delete a user.

2. Enter the User Name. This should be a unique name associated with this user.

3. Enter the User Id. This is the unique user name associated with the user.

4. Enter the Email Address of the user.

5. Select the Site from the drop-down list. The user is assigned to this site.

6. Select the User Type from the drop-down list.

7. Select the language from the drop-down list in Modify Language Narrative.

8. This is the language the user has access to in the multi-lingual fields.

9. Select the following options in Access, as per your requirements.

Field Name

Purpose

Account Disabled

Enables the administrator to disable the account.

Security Disabled Account

Enables the administrator to disable the account depending upon the number of consecutive unsuccessful login attempts.
When unchecked:

The login procedure keeps track of the number of consecutive unsuccessful attempts at logging into the system. If the count reaches three, the login procedure will always fail the password validation and lock the user out.

Administrators with rights to user maintenance can reset the login attempts for the user to unlock the account.

When checked:

The login procedure to keep track of the consecutive unsuccessful attempts at logging into the system does not apply.

ESM Admin

Enables the administrator to give the Argus user access to the ESM Mapping utility.

Force Password change at login

Ensures that password is changed at login.
Select this field to force Argus users to change their password, when they log in to the application for the first time.

Force password to expire every x days

Enter the maximum number of days for the user(s) to retain user password.

Reset Password

Select this field to reset the user password.

10. Select the following options in Case Form, as per your requirements.

Field Name

Purpose

Allow unblinding of Cases

Select this to allow the user to unblind a study case.
A user with no rights of unblinding a case cannot see the Study Drug field.

Users with Unblinding rights see a yellow tag "Unblind" adjoining the Concentration of product field.

The Broken by Sponsor' option in Blinding Status drop-down is enabled.

User has to enter password when on selecting the "Broken by Sponsor" option

Protect from unblinded information

Allows the Administrator to protect a user from unblinding information such as Study Drug, Concentration, Dosage Regimens and Total Dosage.

Protect from printing unblinded information

Select this to disable the user from printing unblinded information.

Allow locking of cases

Select this to allow the user to lock cases.

Allow closing of cases

Select this to allow the user to close cases.

Route on Close Case

Select this to disable the case routing dialog which appears when the users selects Case Actions -- Close Case on the case form.

11. Select the User Group.

12. Enable the Application Access for different applications such as Argus, Power Reports or Console.

13. Select the Default application access from the drop-down list, for the user.

14. Select the default worklist to be displayed on logging onto Argus from the Worklist to display at login drop-down list, for the user.

15. Select the Workflow manager checkbox to give the user more rights within the system.

16. Select the Enterprise checkbox to configure a 'Workflow Manager' user as an 'Enterprise user'. The user can view cases of any site outside its site too. This field is enabled only when the 'Workflow Manager' field is checked.

17. Select the Enable Site Security checkbox to enable site based security data for the user.

18. This is made possible through the Site Access Configuration dialog.

19. The Site Access Configuration section enables a user to get access to additional sites.

20. The administrator can select the access level by selecting from the options available in this dialog.
The following table describes the access levels in this dialog:

21. Select the Enable LDAP Login checkbox to allow the user to be authenticated against the active directory server.

22. Click Save to add the newly created Argus Affiliate user.

Configuring the Affiliate System Numbering

The system provides the ability to use multiple case numbering schemes for globally. For example, if site is used in the numbering, the system provides the option to keep separate sequences for each site. However, Affiliate System Numbering configuration can only be done from Argus Safety application. Therefore, to configure the Affiliate System Numbering, the Administrator must be logged on to Argus Safety application.

Select Argus Console >System Configuration > LAM System Numbering to view the Affiliate System Numbering screen. The following is an illustration of the LAM System Numbering page.

The following table lists and describes the fields on the LAM System Numbering page.

Field

Description

Manually Number Cases

The option enables the user to manually number the cases on booking or while copying the case, using the "save as" option on the case form.

Automatically Number Cases

On selection, the system automatically numbers the cases as defined by the user in the numbering format.

Start at

Enables the user to initialize the counter of the sequence number.

Separate sequence for each site

Enables the user to separate the sequence numbering for cases on site by site basis. If there are cases being entered from two different sites then each site will have different sequencing of case numbers.

Separate sequence for each report type

Enables the user to separate the sequence numbering for cases by the report type of the case.

Separate sequence for each year

Enables the user to reset the sequence numbering for cases after each year, based on the initial receipt date of the case.

Separate sequence for each month

Enables the user to reset the sequence numbering for cases after each month, based on the initial receipt date of the case.

Separate sequence for each product abbreviation

Enables the user to reset the sequence numbering for cases for each different product abbreviation.

Numbering Format

Enables the user to select the numbering format by selecting the different placeholders.
Define the numbering format by typing in custom keywords to print on every case number & selecting different placeholders.

[YY][MM]-[###] is the default format.

Placeholder

Enables the user to enter a placeholder.
Placeholders are used to pickup values from the database to be used in the Case numbering format.

The possible values populated in this list are:

- . # -- Number: defines the digits to be used as the sequence number in the format. The field is used to display the sequence number on the case numbers.

- CC-- Country code: When selected, this uses the A2 code for the country of incidence for the case number.

- DD -- Day: When selected, this uses the date of the "Initial receipt date" field of the case.

- MM -- month: When selected, this uses the month of the "Initial receipt date" field of the case.

- P -- When selected, this uses either of the two values:
a. If report type is "Spontaneous" or " other" during booking: the system uses the value of the "Product Abbreviation" field specified in the Product configuration for the selected Primary suspect product.

b. If report type is of the type "report from study" during booking: the system uses the "Product Abbreviation" field specified in the study configuration.

- SSS -- User Site: When selected this uses the Site abbreviation of the site belonging to the user who booked in the case

- TTT -- Report Type: When selected this uses the report type abbreviation of the report type selected during bookin of the case

- YY -- Year: When selected, this uses the year of the "Initial receipt date" field of the case.

To Configure Affiliate system numbering

1. Select the Numbering feature as required. This can be manual numbering or automatic numbering of cases.

2. Select the Sequencing Options as required.

3. Select the Numbering Format. Use Placeholders to enter the required format.

Note:
To customize the Numbering Format, use the placeholder values.
Example: To select Country Code, Month and Year (as values to be incorporated from the database) as the Case numbering format, execute the following steps.

1. Click on Country Code. This appears in the Numbering Format field.

2. Click on Month. This appears in the Numbering Format field next to the Country Code.

3. Click on Year. This appears in the Numbering Format field next to the Country Code and Month.

4. The final data listed in the Numbering Format field is the Case Numbering Format.

4. Click Save to save the changes made.

Viewing the Audit Log

The LAM Audit Log can only be viewed from the Argus Safety application. The following is an illustration of the LAM Audit Log.

To View the Affiliate Audit Log

1. Go to Utilities > Logs > LAM Audit Log to open the LAM Audit Log.

2. The following table lists and describes the fields in the LAM Audit Log.

Field

Description

Search Conditions

From

Enter the initial date of the time period to be searched

To

Enter the end date of the time period to be searched

Search button

Displays the results of the specified search criteria.

Total Number of Rows

Action

Displays the Audit Log Details screen

Activity

Displays the status of the activity. Displays whether it has changed or not.

Audit Data

Displays the audit data

User

Displays the last user who made changes to the case

Field

Description

Date/Time

Displays the last time the case was changed.
Note: The time displayed is as per GMT.

Print List button

Prints the list of all the logs.

Searching the Audit Log

Use the following procedure to search the Audit Log.

To search the audit log:

1. Enter a date range for which the audit log is to be viewed. A date range can also be selected from the Range list.

2. Click Search.

3. A list of LAM Audit Log items matchin`g the search criteria appears in Total Number of Rows.

4. Click the Action icon displayed against each search result in Total Number of Rows to open the Audit Log Details screen.

Note:
The lower half of the Audit Log Details screen displays the list of all the revisions made in the case.

The following table lists and describes the fields on the Audit Log Details screen.

Field

Description

Total Number of Rows

Displays the total number of rows in the list

Parent

Displays the parent page where the change has been made.

Field

Displays the field where the change has been made.

Old Value

Displays the previous value.

New Value

Displays the new, changed value.

Rev

Displays the revision number. The list is sorted in descending order of the revisions that have been made so the latest revision is displayed at the top.

User Name

Displays the name of the last user who made a change.

Revisions Date

Displays the last date when the change was made.

User

Displays the name of the user who last made the revision.

5. Click a row displaying a revision.

6. The system displays the details in the upper half of the screen.

Tip:
Multiple selections can be made to view the details of revisions.

Glossary

Clinical Trial

A research study. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority approval of new therapies.

Electronic Document

A document that is stored on the computer, instead of printed on paper.

Encode

To convert data by the use of a code in such a manner that reconversion to the original form is possible.

Field Description

Information that describes the characteristics of data in a field.

Field Format

A format in which the output consists of structured field introducers and variable data rather than output in line format.

Filter

A device or program that separates data, signals, or material in accordance with specified criteria.

Home Page

The top-level Web page of a portal. Sometimes used as a synonym for default portal page.

Lower Level Term

The MedDRA dictionary is organized by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lower-Level Terms (LLT). The Current MedDRA version is 9.0 (March 2006).

MedDRA

A clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the ICH (International Conference on Harmonization). MedDRA is used in the US, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.

Portable Document Format

Portable Document Format (PDF) is a file format proprietary to Adobe Systems for representing two-dimensional documents in a device independent and resolution independent fixed-layout document format.

Report

A formatted presentation of information relating to a model or to process simulation results. Reports can be viewed online, printed, or exported to a variety of file formats. Data that has been selected and extracted according to the reporting tool, the type of report desired, and formatting criteria

Rich Text Format (RTF)

A document file format developed by Microsoft for cross-platform document interchange.

Text

A broad term for something that contains words to express something

Universal Resource Locator

In addition to identifying a resource, URLs provide a means of locating the resource by describing its primary access mechanism (e.g., its network 'location').

Web Browser

A client program that initiates requests to a Web server and displays the information that the server returns.

Web Page

Any document that can be accessed by a URL on the World Wide Web

Web Server

A software program that is capable of servicing Hypertext Transfer Protocol (HTTP) requests.

Web Site

A related collection of files available on the Web that is managed by a single entity (an organization or an individual) and contains information in hypertext for its users. A Web site often includes hypertext links to other Web sites.

Oracle Legal Notices

Copyright Notice

Copyright © 1994-2017, Oracle and/or its affiliates. All rights reserved.

License Restrictions Warranty/Consequential Damages Disclaimer

This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited.

Warranty Disclaimer

The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing.

Restricted Rights Notice

If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, then the following notice is applicable:

U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and adaptation of the programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to the programs. No other rights are granted to the U.S. Government.

Hazardous Applications Notice

This software or hardware is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software or hardware in dangerous applications.

Trademark Notice

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark of The Open Group.

Third-Party Content, Products, and Services Disclaimer

This software or hardware and documentation may provide access to or information about content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services unless otherwise set forth in an applicable agreement between you and Oracle. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services, except as set forth in an applicable agreement between you and Oracle.

Pre-General Availability Draft Documentation Notice

If this document is in public or private pre-General Availability status:

This documentation is in pre-General Availability status and is intended for demonstration and preliminary use only. It may not be specific to the hardware on which you are using the software. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to this documentation and will not be responsible for any loss, costs, or damages incurred due to the use of this documentation.

Private Pre-General Availability Draft Documentation Notice

If this document is in private pre-General Availability status:

The information contained in this document is for informational sharing purposes only and should be considered in your capacity as a customer advisory board member or pursuant to your pre-General Availability trial agreement only. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described in this document remains at the sole discretion of Oracle.

This document in any form, software or printed matter, contains proprietary information that is the exclusive property of Oracle. Your access to and use of this confidential material is subject to the terms and conditions of your Oracle Master Agreement, Oracle License and Services Agreement, Oracle PartnerNetwork Agreement, Oracle distribution agreement, or other license agreement which has been executed by you and Oracle and with which you agree to comply. This document and information contained herein may not be disclosed, copied, reproduced, or distributed to anyone outside Oracle without prior written consent of Oracle. This document is not part of your license agreement nor can it be incorporated into any contractual agreement with Oracle or its subsidiaries or affiliates.

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.