Unable To Open E2B R2 For PMDA When DLP Is Enabled

(Doc ID 2349506.1)

Last updated on MAY 30, 2018

Applies to:

Oracle Argus Safety Japan Cloud Service - Version 8.0 and later
Information in this document applies to any platform.

Symptoms

E2B R2 for PMDA is unable to be opened when DLP Is Enabled.
When clicking Draft link of E2B report on Case Form >> Regulatory Reports, error message is displayed on a pop-up dialog window.
It is not related with MKT and INV license report, occurs regardless the E2B is for MKT or INV license.

 

ERROR MESSAGE:
---------------------

エラー番号:402000609 詳細 Case <case#> General error while creating E2b report.
The reporting category is not defined for case_num: <case#> and reg_report_id: <id#> on the PMDA tab.
Validation could not be performed. Stored Procedure: GENERATE_SAFETYREPORT 報告の詳細を参照してください。

 

Error#:402000609 Details: Case <case#> General error while creating E2b report.
The reporting category is not defined for case_num: <case#> and reg_report_id: <id#> on the PMDA tab.
Validation could not be performed. Stored Procedure: GENERATE_SAFETYREPORT Please refer report details.

 

HOW TO REPEAT:
---------------------
1. DLP enabled environment
In cmn_profile_enterprise -> DLP_ENABLED = 1 , DLP_EXPEDITED_E2B_REPORTS= 1.
2. Console setting:
Argus Console >> System Configuration >> System Management (Common Profile Switches) >> Common Profile >> Case Form Configuration >> Modify Data Lock Point >> Enable Data Lock Point check-box = Checked
3. Create PMDA R2 agency in Reporting destination and check the checkbox "Use Japanese Aware Date for Reporting".
4. Try with a Product having two licenses: Marketed Drug-US, Marketed Drug-Japan.
5. Log in in Argus with English User.
6. Create a case with above product with following details:
Initial receipt date = 04-May-2017, Central receipt date = 04-May-2017
Country = US, Report Type: Spontaneous and populate other mandatory fields.
7. Once case is created, populate other field data such as:
Reporter Information:
Health Care Professional = Yes; Country = US; Reporter Type = Pharmacist
Patient: Patient Initial = PAT
Event Information: Outcome of event = Unknown; Medically Significant = checked; and compete the event assessment as unlisted.
Analysis: Narrative
8. Save the case, lock the case.
9. Unlock the case with significant follow-up and populate
Follow-up Received date: 30-May-2017; Safety Received date: 30-May-2017
10. Save the case, lock the case
11. Unlock the case with significant follow-up and populate
Follow-up Received date: 21-Jun-2017; Safety Received date: 21-Jun-2017
12. Save the case, lock the case.
13. Logout and log in with Japanese user
14. Unlock the case as "Other" and go to Analysis -> PMDA tab and update the below dates as follows:
Japanese initial date: 2017/06/23
Japanese follow-up1 date: 2017/06/26
Japanese follow-up2 date: 2017/06/26
15. Populate License Type: 'Under surveillance immediately after put on market' and category: 'D - Overseas/ADR report (Marketed drug)' in the same tab.
16. Switch the tab to PMDA Info >> Comments and populate the comment as "test data".
17. Save the case and lock the case.
18. Go to Regulatory tab and schedule an E2B report on
Product Japan license on above created PMDA R2 agency
19. Click on Draft link.
20. An error will appear:
21. Disabled the dlp for Expedited reports.
In cmn_profile_enterprise -> DLP_EXPEDITED_E2B_REPORTS= 0
Console setting:
Argus Console >> System Configuration >> System Management (Common Profile Switches) >> Common Profile >> Case Form Configuration >> Modify Data Lock Point >> Enable Data Lock Point check-box = Unchecked
22. Click on Draft link.
Report should open without any error.

 

 

 

Cause

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