Unable To Accept Imported E2B Case With Missing Study Number: ORA-01403: no data found, Fatal Error: Unable to validate the study number for [2]. Module: P_VALIDATE_ARGUS_MIN_REQ (Doc ID 1454522.1)

Last updated on JULY 07, 2016

Applies to:

Oracle Argus Interchange - Version 6.0 and later
Oracle Argus Safety - Version 6.0 and later
Information in this document applies to any platform.
***Reviewed for currency: 02-JAN-2015***

Symptoms

Cases received from the Spanish Authority cannot be accepted after import.  The following error is received:

ORA-01403: no data found, Fatal Error: Unable to validate
the study number for [2]. Module:
P_VALIDATE_ARGUS_MIN_REQ

This is a clinical case (reporttype = 2) with the observestudytype = 3. The E2B data elements studyname and sponsorstudynumb are null. Per EMA Note for Guidance this is acceptable. The E2B data elements studyname and sponsorstudynumb are only mandatory if the observestudytype = 1. If the observestudytype = 2 or 3 the other elements mentioned already are not mandatory.

Cause

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