B.4.k.1 Drugcharacterization Has Value 4 In FDA E2B(R2) V2.1
(Doc ID 2880240.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2.3.1 to 8.4 [Release 8.2 to 8.4]Information in this document applies to any platform.
Symptoms
When viewing FDA E2B(R2) V2.1, B.4.k.1 <drugcharacterization> has the value (4) which is "DRUG NOT ADMINISTERED".
However, the value "4:Drug not administered" is allowed in FDA E2B(R2) V2.2 only, not V2.1 format.
FDA does not accept the value(4) for B.4.k.1<drugcharacterization> in FDA E2B(R2) V2.1 so that the following ERROR ACK received.
Steps:
1. Create a case
2. In the product tab, add the product and check on "Drug Not Administered"
3. Enter the mandatory for FDA E2B(R2) v2.1
4. Schedule FDA E2B(R2) v2.1
5. Save the case
6. Click the draft/final link to view the report (which is using FDA V2.1 message profile)
Changes
Cause
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