Case Identification Number Does Not Populate In PMDA E2B C.1.10.r (Doc ID 2968691.1)

Last updated on MARCH 18, 2024

Applies to:

Symptoms

The worldwide unique case identification number (COMPANYNUMB) does not populate in C.1.10.r when viewing PMDA E2B (R3) as the research/foreign measurement report.

Steps to replicate:

In the codelist : reporting destination > EDI tab, the "Allow multiple reports for Investigation Drugs (Research and Measure)" is checked.

Steps:

1. Create a case with several Japan licenses (at least one of the licenses is investigational license)
   
2. Enter the mandatory information for PMDA E2B
3. Schedule PMDA E2B
4. Lock and close the case
5. Generate the final report with the value of C.1.8 COMPANYNUMB
   
6. Transmit and submit the report
   
   
7. Open the case form and confirm that E2B Company Number with the case identification number (COMPANYNUMB) is populated in the additional information > reference section
   
   
   
8. Schedule PMDA E2B as the research or foreign measurement report for Japan investigational license (for example: reporting category : M)
9. Click the draft link in the regulatory report tab
   
   E2B displays without C.1.10.r so the case identification number (COMPANYNUMB) does not populate in this report.
   

Scenario#2: Generate PMDA E2B as the research or foreign measurement report and then schedule another PMDA E2B for Marketed or Investigational (clinical drug)

The case identification number (COMPANYNUMB) does not populate in 2nd report (PMDA E2B for Marketed or Investigational (clinical drug))

Scenario#3: Generate PMDA E2B for Marketed or Investigational (clinical drug) and then schedule another PMDA E2B as the research or foreign measurement report

The case identification number (COMPANYNUMB) does not populate in 2nd report (PMDA E2B for research or foreign measurement report)

Changes

Cause

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.