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A.2.3.X items are not generated in the 1st A.2 block in PMDA E2B (Doc ID 2027928.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Interchange - Version 7.0.3 to 8.1 [Release 7.0.0 to 8.1]
Information in this document applies to any platform.


When a study case is having multiple Reporters and the Primary Reporter is not the 1st Reporter added to the case at earliest, and E2B is generated,
the generated E2B contains multiple A.2 blocks according to the case existing Reporters. Among A.2 block repeats, Primary Reporter's A.2 block comes to 1st.

The A.2.3.X items are not output to the 1st A.2 block in the generated E2B but A.2.3.X items are in the A.2 block of the first inserted Reporter to the case.

As the result, if this E2B is sent to PMDA, PMDA returns an error Ack with Error Code 30104401.
(Error Code 30104401: "In spite that A.1.4 is not "2", A.2.3 exists" OR "In spite that A.1.4 is "2", A.2.3 does not exist in the 1st repeat.")
If the 1st A.2 block contains the A.2.3.X items, PMDA does not return the Ack of Error Code 30104401.

Cases that have a clinical report type that was initially reported by a consumer and then follow up is received by a HCP who is marked as the primary reporter.
The E2B to PMDA fails because the study information is linked to the consumer reporter.

1. Book In a study case as Argus J user
2. Set the existing reporter as Primary Reporter, Reporter Type: Consumer or other Non HCP, HCP: No
3. Add other required information in the case
4. Schedule and generate an E2B to PMDA. -- One A.2 block exists with A.2.3.X items.
5. Transmit the E2B to PMDA with Mark as Submitted.
6. Import Ack -- Initial E2B report state='Submitted'.
7. Unlock the case as significant follow-up.
8. Add another reporter as Reporter Type: Physician, HCP: Yes.
9. Make the second reporter as Primary
10. Schedule a Follow-up #1 E2B.
11. Click Draft link of F/U#1 E2B. -- Two A.2 blocks exist. A.2.3.X items are in the 2nd A.2 block.
12. Transmit this Follow-up E2B to PMDA. -- PMDA returns error Ack with Error Code 30104401.




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