PMDA ACK Import Logic

E2B (R2) Reports

The MARK AS SUBMITTED logic has been updated for PMDA E2B reports.

The following scenario is being used to explain the requirement,

The PMDA E2B Report and PMDA ACK element are being referred using the Data Element Numbers in the requirement:

PMDA E2B (R2) ACK:

A.1.6 (TRANSMISSIONACKNOWLEDGMENTCODE)
Possible Values as per ICH:

01= All Reports loaded into database

02= ICSR Error, not all reports loaded into the database, check section B

03= SGML parsing error, no data extracted
B.1.8 (REPORT ACKNOWLEDGMENTCODE)
Possible Values as per ICH:

01=Report Loaded Successfully

02=Report Not Loaded
B.1.9(ERRORMESSAGECOMMENT)

The application has been enhanced such that, when an ACK is received against PMDA E2B report with A.1.6 = 01, B.1.8 = 02, the application treats it as a Positive ACK with warning and marks the report as submitted.

The report submission behavior for different combination of ACK's against PMDA E2B Reports is:

Ack: A.1.6 = 01, B.1.8 = 01 - Positive Ack, Report is marked as submitted
Ack: A.1.6 = 01, B.1.8 = 02 - Positive Ack with Warning, Report is marked as submitted
Ack: A.1.6 = 02, B.1.8 = 01 or 02 - Negative Ack, Report is not marked as Submitted.
Ack: A.1.6 = 03, B.1.8 = 01 or 02 - Negative Ack, Report is not marked as Submitted.

This behavior of marking PMDA E2B Report as submitted against the positive ACK is applicable only when the report submission is set to any of the following values:

Use MDN Date as Submission Date and Mark report as submitted only on Positive ACKs.
Use Business Level ACK Date as Submission Date and Mark report as submitted only on Positive ACKs.
Use Submitted date as entered by the user and Mark report as submitted only on Positive ACKs.

E2B (R3) Reports

A separate ACK profile is available for the PMDA E2B R3 ACK "ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA". It consists of all the Export and Import mapping logic in the OOTB Acknowledgment profile.

The following section explains the import of ACK:

PMDA Number (B.r.2)
1. PMDA number (B.r.2) element in the PMDA E2B R3 ACK corresponds to the B.1.3 element in the PMDA E2B R2 ACK.
2. PMDA has made some modification to structure/information in PMDA Number that is sent against the E2B R3 report as compared to the corresponding information for PMDA R2 ACK; the PMDA number format for PMDA E2B R3 is:
  XX-YYYYYYYY-ZZ
  
  XX: represents the 2 digit E2B (R3) code of reporting category of the original ICSR submitted by the company.
  
  YYYYYYYY: represents the 8 digit unique PMDA ID provided to a successfully loaded ICSR.
  
  ZZ: represents the count of successfully loaded initial and follow-up reports for that case and reporting category. This is sent by PMDA to the company for information purposes only.
3. Application logic for ACK import has been enhanced such that application identifies the ACK that is getting imported is against the PMDA E2B R3 report, the import logic has been enhanced to handle the newly added ZZ component in the such a way that it is loaded in the ESM schema and is available for user to view in the Report Details Dialogue View ACK Acknowledgment Report Tracking # and Bulk E2B Transmit Messages (tab) View Acknowledgment (context menu).
4. The Case Form > PMDA Tab > PMDA Number displays only the 8 digit YYYYYYYY number as it does for the PMDA E2B R2 report.
Transmission Acknowledgement Code (A.4) and Acknowledgement Code for a ICSR Message (B.r.6)
The above elements in the PMDA E2B R3 ACK indicate the status of the PMDA E2B R3 report, and the values for the code are in line with that of ICH. For ready reference, below are the values for these elements:

Allowed Values for A.4
- AA - Application Acknowledgement Accept (message successfully processed, no further action)
- AE - Application Acknowledgment Error (error detected, error response has additional detail, some ICSR message(s) need further action)
- AR - Application Acknowledgment Reject (parsing error, no data extracted, re-send the entire transaction)
Allowed Values for B.r.6
- CA - Commit Accept (the ICSR message successfully loaded)
- CR - Commit Reject (the ICSR message contains fatal error that prevents the ICSR from being loaded)
The similar codes A.1.6 and B.1.8 exists in the PMDA E2B R2 ACK file as

Allowed Values for A.1.6
- 01= All Reports loaded into database
- 02 = ICSR Error, not all reports loaded into the database, check section B
- 03= SGML parsing error, no data extracted
Allowed Values for B.1.8
- 01=Report Loaded Successfully
- 02=Report Not Loaded
1. Currently while importing the ACK for PMDA E2B R2 if the ACK File is received such that the value of A.1.6 = 01 and B.1.8 = 02 the application interpret it to ACK with a warning i.e. the PMDA has loaded the report in there system but are some warnings for which a follow-up report is required.
2. As per the PMDA E2B R3 guideline the same warning situation is indicated with A.4 = AE and B.r.6 = CA, and application logic shall be enhanced to handle the warning ACK similar to that of PMDA E2B R2
3. The warming ACK shall be handled across the application not limited to the following locations:
  - ACK Import
  
  - Worklist ' Bulk E2B Transmit (Reports & Messages Tab)
  
  - Report Details Dialogue

The following table explains the possible combinations for A.4 and B.r.6 in a PMDA E2B R3 ACK file:

A.4	B.r.6	Results
AA	CA	Positive
AE	CA	Warning
AE	CR	Negative
AR	CR	Negative
AA	CR	Invalid
AR	CA	Invalid

When both the transmission ACK code and report ACK code is 01, then the ACK shows a green tick mark in the Argus Report Status window.

When the transmission ACK code is 01, the report ACK code is 02 & PMDA R2, then the ACK shows an orange tick mark in the Argus Report Status window.

When the transmission ACK code is 02, the report ACK code is 01 & PMDA R3, then the ACK shows an orange tick mark in the Argus Report Status window.

In case of any other combination of transmission ACK code and report ACK code, the ACK shows a red X mark in the Argus Report Status window.

Parent topic: Monitor ICSR Transmit Status