ARGUS SAFETY DATABASE

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Common Icons

Common Icons
Icons	Description
	These icons help the user to traverse to the left or right side in a page.
	A standard Notes dialog is available.
	Re‐arranges the entered items by moving them up or down.
	Depicts the column that is currently being sorted.
	The orange dot depicts a warning to enter a justification for a non-mandatory field.
	The green dot depicts that a justification has been selected or entered for the field.

Common Right Click Options
Right-click Option	Description
Re‐arrange	Re‐arranges the selected item.
Delete	Deletes the selected item.
Copy	Copies the selected item.

Tab Navigations

General Tab

Report Type

Follow-ups

Study Information

Literature Information

Reporter Information

Patient Tab

Patient Information

Patient Details

Pregnancy Information

Other Relevant History

Patient Lab Data

Relevant Tests

Parent Information

. Products Tab

Product Information

Product Indication

Dosage Regimens

Product details

Events Tab

Event Information

Event Coding

Event Seriousness Criteria

Event Details

Event Assessment

Analysis

Narratives

Case Summary

Activities

Contact Log

Action Items

Routing Comments

Case Lock/Archive

Additional Info

Notes and Attachment

References

Regulatory Reports

Reports: Expedited & Periodic

SAE case Workflow

1. Case Intake

2. Triage

3. Data Entry

4. Quality Control (QC)

5. Medical Review

6. Distribution & Submission

7. Filing / Closed / Archived

8. Sponsor Approval

9. Case Unblinding

10. Case Monitoring

Initial Case Entry

1. Initial Receipt Date

2. Country (of incidence)

3. Report Type

4. Product Name

5. Description as Reported (Adverse Event)

6. Reporter Information (Name and Address)

7. Patient Identifier(s)

8. Serious Criteria

Entry of Literature Information

Activities Tab

Action Items

Case Locked / Archive / Unlocked

In the Regulatory Reports tab, you are able to view, schedule, generate, approve and submit reports. Data Entry users will have limited access to this area. Regulatory Reporting users having primary responsibility for expedited or periodic reports, and therefore have full access.

For marketed products, the expedited reporting rules are configured for 15 day reports for domestic and foreign report destinations. The Product Name does not appear on the expedited reports; the Trade Name of the selected license associated with the product appears on the expedited reports. The license trade name should reflect the local trade name in the country of authorization, when possible.