Unable to create PMDA E2B initial report with a new value after Nullification (Doc ID 2032926.1)

Last updated on SEPTEMBER 08, 2016

Applies to:

Oracle Argus Safety Japan - Version 7.0.5 and later
Information in this document applies to any platform.

Symptoms

The initial PMDA E2B report with a new data cannot generate after sending the nullification report.

 

Steps to reproduce:

Sample scenario#1 : Submit the nullification report because reporting category (J.4a) has been changed.

1. Go to case form > Analysis > PMDA Info
2. Set the reporting category (A)
3. Save the case
4. Go to regulatory report tab
5. Press the [Auto Schedule] button and confirmed that initial PMDA E2B has been scheduled
6. Submit the report
7. Receive ACK

8. Unlock the case as significant info
9. In the event tab, Uncheck the infection flag
10. Go to analysis > PMDA info tab and set the reporting category(B)
11. Save the case

Follow the steps below in order to schedule the nullification report.

Sample scenario#2 : Submit the nullification report because Other sender's case report number (A.1.10.2) was different.

1. Go to regulatory report tab
2. Press the [Auto Schedule] button and confirmed that initial PMDA E2B has been scheduled
3. Submit the report
4. Receive ACK

5. Unlock the case as significant info
6. Go to additional information tab and change the value of E2B Company Number.
7. Save the case

Follow the steps below in order to schedule the nullification report.


---Schedule nullification report and new report -----------------------

1. Go to the regulatory report tab
2. Unsubmit the initial report and confirmed that nullification report has been scheduled
3. Submit the report
4. Receive ACK for the nullification report

5. Go to regulatory report tab
6. Confirmed that the status of nullification report is displayed as "Submitted".

7. Schedule a new report for PMDA E2B
The follow-up report has been scheduled which is incorrect. The initial report should be scheduled.

8. Click the draft link

The PMDA ICSR validation error appears. Please note that the contents of the error will be different depends on the reasons for submitting nullification report.

For sample scenario#1:

J.4a MHLWADMICSRCASENUMCLASS
症例フォーム / 解析 / PMDA情報 / 一般 / 被疑薬ライセンスの情報報告分類
項目 [MHLWADMICSRCASENUMCLASS (J.4a)] の値が前回報告時のものと一致しません。 [解析 | PMDA情報 | 一般 | 報告分類]
***Translation: [MHLWADMICSRCASENUMCLASS (J.4a)] value does not match the value from the previous report.

For sample scenario#2:

A.1.10.1.2 COMPANYNUMB
項目 [AUTHORITYNUMB (A.1.10.1)] の値が未入力時に、項目[COMPANYNUMB (A.1.10.2)]が前回報告時のものと一致しません。
***Translation: Value of [COMPANYNUMB] doesn't match with the last report when [AUTHORITYNUMB] is not entered.

 

 

Cause

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