Nullification and New Initial Reports are Not Included in Second Scheduling Period of PSR in Form 3
(Doc ID 2802686.1)
Last updated on AUGUST 31, 2021
Applies to:Oracle Argus Safety Japan - Version 8.2.2 and later
Information in this document applies to any platform.
When 'Event counting logic for PSR Form 3, 4 and ReSD Form 10, 11' is set for option 3 (Count each event from a case with the timeframe where the case was reported last),
nullification and new initial reports are not included in second scheduling period of PSR in form 3.
Steps to reproduce:
1) In Argus Console > System Configuration > System Management > Argus J > Reporting > Event counting logic for PSR Form 3, 4 and ReSD Form 10, 11, select 'Count each event from a case with the timeframe where the case was reported last'.
2) Save the setting
3) Close Argus Console screen
4) Logout and re-log in to Argus
5) Create a case with the following criteria
Report type = Spontaneous
COI = Japan
Product A (with Japan marketed license)
Event 1: Hepatitis B, Medically Significant, Related & Unlisted and check Infection box for the event
Reporting category = A (Domestic Infection)
6) Enter all necessary data for PMDA reporting to the case
7) Auto schedule initial report
8) Transmit the initial report
9) Receive acknowledgment
10) Configure a PSR to include the created case in first period
11) Generate the PSR and confirm the case is included in the PSR
12) Unlock the case, add significant follow up
13) Delete Event 1, example: Hepatitis B
14) Add Event 2, example: Bleeding and make this as primary event, Medically Significant, Related & Unlisted
15) In PMDA Info tab change reporting category to B (Dom ADR)
16) Perform Global and Local lock and auto-schedule. Nullification report should be scheduled by Argus (due to Reporting category change) and another initial report should be schedule
17) Submit both nullification and the new initial report
18) Copy the PSR and add second period to the report configuration which will include the nullification and new ADR report
19) Generate the PSR
20) Nullification and new initial reports are not included in second scheduling period of PSR in form 3
To view full details, sign in with your My Oracle Support account.
Don't have a My Oracle Support account? Click to get started!
In this Document