J2.13.r.2 Conditional Mandatory Error appears when viewing PMDA E2B (R3) INV report from non-study case (Doc ID 2333894.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

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Issue:
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When viewing PMDA E2B R3 (INV) report from the non-study case, ICSR validation error appears to J2.13.r.2 as a Conditional Mandatory error.

Note that the value in the target disease (J2.13.r.2) exists in the study configuration.

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ICSR Validation Error:
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Conditional Mandatory

          ICSR Element          : J2.13.r.2
          ICSR Field Location : Business Configuration/Studies/Target Disease
          Error Description     : Value for J2.13.r.2[MHLWINDICATIONFORSTUDY] should exist if the MHLWINDICATIONFORSTUDY J2.13.r.1[MHLWNOTIFICATIONNUMBER] is blank.

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STEPS
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1. Product(A) have the Japan INV license
2. STUDY(001) has this product(A)
3. In the study configuration, confirm that the value of J2.13.r.2 exists in the "target Disease".
     In addition to this, confirm that the value of J2.13.r.1 "Number of notification" is a blank field because this study is not required to submit a clinical study plan notification.
4. Create a new spontaneous case
5. In the analysis > PMDA information tab, set the reporting category (I) to the Japan INV license
6. Enter the mandatory value for PMDA E2B (R3)
7. Save the case
8. Go to the regulatory report tab
9. Schedule PMDA E2B (R3) to the Japan INV license
10. View the report

Changes

Cause

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