IND# Field (G.5) In The Medwatch Form is Not Getting Populated

(Doc ID 1445815.1)

Last updated on MAY 27, 2016

Applies to:

Oracle Argus Safety - Version 6.0.4 and later
Information in this document applies to any platform.
***Checked for relevance on 19-Aug-2014***

Symptoms

The system is not populating the IND# field (G.5) of the medwatch form with the IND license number configured under clinical references section in the study configuration for the manually scheduled reports against the who drug products in the study cases.

Steps to Repeat:
1. Create a blinded study with one company drug and one who drug
2. Add IND reference with a license number in the study configuration under clinical references section
3. Create a study case using the study created in step 1
4. Unblind the case and select the who drug as the study drug in the products tab and save the case
5. Lock the case
6. Manually Schedule a report for the study drug selected in the case
7. Save the Case
8. Generate the MedWatch Report
9. Observe that system did not populate the IND# field of the medwatch form with the IND license number configured under clinical references section in the study configuration.

Cause

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