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Creating blank audit log revisions for cases when recoding using recoding tool (Doc ID 2021745.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 7.0.1 and later
Information in this document applies to any platform.

Symptoms

System is creating a blank audit log revision for the cases when recoding events using meddra recoding tool and also these cases are not listed in the MedDRA_Recode_Success log

Steps to Repeat:
1. Configure MedDRA dictionary as MedDRA Brows 17.0 for events and indications in Argus Console, Log out and log back in
2. Create a case with the following event, encode using MedDRA Brows 17.0 and save the case
      Description as Reported: Expired drug administered
      Description to be Coded: Expired drug administered
      MedDRA V 17.0
      Preferred Term (Code):   Expired drug administered (10066434)
      Lower Level Term (Code): Expired drug administered (10066434)
3. Configure MedDRA dictionary as MedDRA Brows 17.1 for events and indications in Argus Console and log out
4. Recode the events using meddra recoding tool from medDRA version 17.0 to 17.1
5. Log back into Argus and open the case that was created in step 2, go to events tab and observe that it correctly recoded the event to Version 17.1
    MedDRA V 17.1
    Preferred Term (Code):   Expired product administered (10074902)
    Lower Level Term (Code): Expired drug administered (10066434)
6. Configure MedDRA dictionary as MedDRA Brows 18.0 for events and indications in Argus Console and log out
7. Recode the events using meddra recoding tool from medDRA version 17.1 to 18.0
8. Log back into Argus and open the case that was created in step 2, go to events tab and observe that it correctly recoded the event to Version 18.0
MedDRA V 18.0
Preferred Term (Code):   Expired product administered (10074902)
Lower Level Term (Code): Expired drug administered (10066434)

9. Check the audit log for this case and observe that it created a new audit log revision but with no details (blank)
10. Check the MedDRA_Recode_Success log and observe that this case was not listed in it

Cause

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In this Document
Symptoms
Cause
Solution
References


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