PMDA E2B Report Mapping for SERIOUSNESS [A.1.5.2]

The PMDA profile E2B transmission logic for SERIOUSNESS [A.1.5.2] tags considers on those events which have been included in the PMDA E2B based on event reportability criteria. This is applicable to the following tags:

• SERIOUSNESSDEATH
• SERIOUSNESSLIFETHREATENING
• SERIOUSNESSHOSPITALIZATION
• SERIOUSNESSCONGENITALANOMALI
• SERIOUSNESSDISABLING
• SERIOUSNESSOTHER

The E2B transmission logic for SERIOUSNESSDEATH tag which currently looks at death details even though it is not related to any event included in the E2B has been removed. It is transmitted as 1 (Yes), only if at least one event which is included the E2B report has Death associated with it. Otherwise, it will be transmitted as 2.This is applicable to all E2B profiles - ICH, FDA, EMEA and PMDA.

The transmission logic for SERIOUSNESSDEATH tag has been removed. It is transmitted as 1 (Yes), only if at least one event which is included the E2B report has Death associated with it. Otherwise, it shall be transmitted as 2.This is applicable to all E2B profiles - ICH, FDA, EMEA and PMDA.

All the E2B check validations for all profiles - ICH, FDA, EMEA and PMDA, related to the following tags will be corrected to only refer to seriousness of the events which are included in the E2B report:

• SERIOUS
• SERIOUSNESSDEATH
• REACTIONOUTCOME

For PMDA E2B reports, if there are no reportable events for the E2B / PMDA Paper Reports, then instead of opening PMDA ICSR Validation Report with missing mandatory tag errors for REACTIONMEDDRAPT and REACTIONMEDDRALLT tags, application shall display an Oracle Argus Safety standard messagebox with OK button and error message: No reportable event exists for the report.

Note:

For additional details, refer to the Oracle Argus Safety Report Mapping Guide (Available from My Oracle Support) that is part of the Technical Reference Manual, as part of this release.