1. User's Guide
  2. Case Form
  3. Analysis Tab
  4. PMDA E2B Report Mapping Updates

PMDA E2B Report Mapping Updates

  • PMDA profile E2B transmission logic for SERIOUSNESS [A.1.5.2] tags considers 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
    • SERIOUSNESSDISABLING
    • SERIOUSNESSCONGENITALANOMALI
    • SERIOUSNESSOTHER
  • 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 is transmitted as 2. This is applicable to all E2B profiles - ICH, FDA, EMEA and PMDA.
  • DRUGSTARTDATEFORMAT and DRUGSTARTDATE (B.4.k.12a and b): PMDA profile E2B transmission logic is also corrected to consider only the reportable events (which are included in the E2B report) when applying the following existing rule:

    When a case has REACTIONSTARTDATEFORMAT and REACTIONSTARTDATE (B.2.i.4a and b) earlier than the first suspect drug's DRUGSTARTDATEFORMAT and DRUGSTARTDATE (B.4.k.12a and b), then the system does not transmit the first suspect drug's B.4.k.12a and b for PMDA reports. When there are multiple events, the comparison is executed in between the oldest REACTIONSTARTDATE, and DRUGSTARTDATE. If there are partial dates, the date are considered as 15th of the month, and the month is considered as June of the year. (The first suspect drug here means the drug for which the report has been scheduled).

  • All the E2B check validations for all profiles - ICH, FDA, EMEA and PMDA, related to the following tags have been corrected to refer to only the 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, the application displays an Argus standard messagebox with OK button and error message - 'No reportable event exists for the report'.
    • This logic is applicable for PMDA Reporting Catergories A,B, C, D, H, I, J, K only.
    • This logic is not applicable to downgrade or nullification reports.
    • This message is displayed in all scenarios wherever the application attempts to open PMDA ICSR Validation Report directly or indirectly, including but not limited to, the following scenarios:

      User attempts to open PMDA E2B report in E2B Viewer

      User attempts to open PMDA ICSR Validation Report

      User attempt to import follow-up E2B and the application is attempting to open PMDA ICSR Validation Report because the E2B being created for the target case does not have any reporting event.

  • A common profile switch identifies the default viewing format of the PMDA E2B (R3) report in the E2B viewer.
    • Native XML View - All the ICH and PMDA specific elements are listed as per the PMDA E2B (R3) Mapping.
    • Decoded View - The ICH and PMDA element in the decoded formats are listed here as per the applicable decoded value based on the allowed values set for the element against the profile. Besides, the element number and decoded element description (both English and J) are based on the "Data Element R3" and Title/J Title respectively as specified by the PMDA E2B (R3) Mapping.
    • HL 7 View - The report appears with in HL7 message format as per the PMDA Guidance.
    • Paper View - The report appears in PDF format as per the PMDA Guidance.

Parent topic: Analysis Tab