PRODUCT_ID And PAT_EXPOSURE Both Populated. (Doc ID 1669950.1)

Last updated on MARCH 08, 2017

Applies to:

Oracle Argus Safety - Version 5.1.3.4 and later
Information in this document applies to any platform.

Symptoms

Oracle Argus Safety Version 5.1.3.4

Normal functionality is that either CASE_PRODUCT.PRODUCT_ID or CASE_PRODUCT.PAT_EXPOSURE are populated.

PAT_EXPOSURE with the PRODUCT_ID the product was unblinded to.

If both fields erroneously are populated, cases qualifying for PSUR reporting will NOT be retrieved by the validated ICH PSUR Template and vice versa, cases NOT qualifying for PSUR reporting will be retrieved and reported to Regulatory.

This matches the issue reported in article "Both Product_ID and PAT_EXPOSURE Columns Have Values in CASE_PRODUCT Table (Doc ID 1361626.1)".

But unable to reproduce according to the steps in that note and is unable to fix using the recommended solution in the same note, therefore need to advise on

a) How to reproduce

b) How to resolve/workaround.

Cause

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