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A.1.13.1 nullification reason information is displayed twice in the nullification report (Doc ID 1642954.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 7.0.2 to 8.0.1 [Release 7.0.0 to 8.0]
Information in this document applies to any platform.

Symptoms

After deleting the case, the nullification report for PMDA E2B has been generated.

In this report, the same information (user name, date, details) is displayed twice in E2B A.1.13.1 <nullificationreason> element.

(eg.,)

<nullificationreason>症例削除担当者 xxx 日時 2014/03/13 05:17:17 GMT 詳細:詳細:症例削除担当者 xxx 日時 2014/03/13 05:17:17 GMT  REASONS</nullificationreason>

 

Steps to reproduce:

1. Submit and transmit the PMDA E2B
2. Receive ACK
3. Open the case
4. Navigate to Case action --> Delete
5. Delete the case and enter the nullification reasons.
6. Check the nullification report (ZIP file)

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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