"B3: Date of Event" Incorrectly Populating in FDA Medwatch 3500A Drug Template Profile
(Doc ID 3047446.1)
Last updated on DECEMBER 10, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.4.2 and laterInformation in this document applies to any platform.
Symptoms
The Argus Safety system currently fills in the "B3 Date of Event" field only for serious related events. However, as per FDA guidelines, this date should not be restricted to serious and related events only.
Steps to repeat:
1. Create a case for a non-serious event.
2. Open the case and navigate to the Events tab.
3. For the non-serious event, enter the Onset Date/Time under Event Information.
4. In the Event Assessment tab, classify the event as non-related.
5. Save the case.
6. Schedule and generate the MedWatch Paper Report using the OOB Profile - FDA MEDWATCH 3500A DRUG TEMPLATE.
7. In the generated report, the B3 Date of Event field is blank. After marking the event as serious and related, the B3 field gets populated.
1. Create a case for a non-serious event.
2. Open the case and navigate to the Events tab.
3. For the non-serious event, enter the Onset Date/Time under Event Information.
4. In the Event Assessment tab, classify the event as non-related.
5. Save the case.
6. Schedule and generate the MedWatch Paper Report using the OOB Profile - FDA MEDWATCH 3500A DRUG TEMPLATE.
7. In the generated report, the B3 Date of Event field is blank. After marking the event as serious and related, the B3 field gets populated.
Cause
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In this Document
| Symptoms |
| Cause |
| Solution |
| References |