Submission Wizard Derives Wrong Reporting Requirement

(Doc ID 761284.1)

Last updated on AUGUST 19, 2009

Applies to:

Adverse Event Reporting System - Version: 4.6.1.10
This problem can occur on any platform.

Symptoms

-- Problem Statement:

Submission Wizard derives wrong Reporting Requirement in the submissions page .Reporting requirement is not getting derived based on the Case level assessment even when the system parameter SUBWIZ_USE_EVENT_TO_DRUG_ASSESSMENT is set to N

-- Steps To Reproduce:
- Confirm system parameter SUBWIZ_USE_EVENT_TO_DRUG_ASSESSMENT is set to N
- Create a new case
- 1 event, seriousness criteria of disability
- event-to-drug: Unlisted=Y, Brochure=Y, Co Related=Y, Rpt Related=DRG
- run the rollup, values rolled up to case level
- save
- run the submission wizard
- note the reporting requirement for DEU in the submissin tab = EXPEDITED (as expected)
- delete the reportability records
- change the CASE level Unlistedness to N
- save
- run the submission wizard again
- note the reporting requirement for DEU in the submissin tab = EXPEDITED (NOT as expected as the
rule is SRU)
- delete the reportability records
- change the Event-to_drug level Unlistedness to N
- save
- run the submission wizard again
- note the reporting requirement for DEU in the submissin tab = NOT EXPEDITED (the wizard seems to
be using the evet-to-drug data)

-- Business Impact:
Incorrect reportability for some cases, compliance issue

Cause

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