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Study Related Fields Are Getting Missed From the Case As Part Of Case Processing (Doc ID 2158767.1)

Last updated on DECEMBER 05, 2019

Applies to:

Oracle Argus Safety - Version 6.0.5 and later
Information in this document applies to any platform.




As part of the case processing, the required case information for study related fields are getting blanked out.
This seems to occur on an intermittent basis and for random users. Some users have been noted to observe the issue more frequently than others.

Because of the missing study information, for one case, it was observed that the case priority gets affected therefore causing compliance risk.

The case update either does not get reflected in the audit log or falls under the user's name who has done the routing.
Note that the users indicate that they are not making the changes.

Below are the steps provided by the user:
data entry > final review > medical review > unblinding (if needed) > distribution

Unable to reproduce in non-production instance

Error No: 305100016 Description: Study Case is missing Study ID. Study Case is missing Study Description. "Case Study->Observe Study Type" is missing.





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