ICH E2B(R3) package v1.11 updates for Observe Study Type

Summary

ICH E2B(R3) package v1.11 updates for Observe Study Type (Enhancements 39413959).

Description

Argus Safety is enhanced to support the new Observe Study Type values introduced in the E2B CL8 ICH-STUDY-TYPE-REVISED codelist of ICH E2B(R3) package v1.11.

Changes include:
  • Codelist

    The following Observe Study Type values are added to the Case Classification codelist:

    • Patient Support Program (E2B Code = 4)
    • Market Research Program (E2B Code = 5)
    • ODCS-Digital Activity (E2B Code = 6)
  • ICH, EMA, and NMPA E2B(R3) profiles

    The new values are added to allowed values for OBSERVESTUDYTYPE [C.5.4].

  • EMA E2B(R3) Validation

    The existing OBSERVESTUDYTYPE [C.5.4] validation for EVHUMAN/EVPM cases is updated to include the new Observe Study Type values.

  • NMPA E2B(R3) Mapping
    The new Observe Study Type values are added to the REPORTCATEGORY [C.1.CN.2] mapping logic to derive the following report category values:
    • Domestic Post-Market Case (NMPA code = 12)
    • Foreign Post-Market Case (NMPA code = 22)
  • MFDS E2B(R3) Mapping
    Updated mapping for the OTHERSTUDIESTYPE[C.5.4.KR.1] element to map the following new Observe Study Type values to 4 – Other:
    • 4 – Patient Support Program
    • 5 – Market Research Program
    • 6 – ODCS-Digital Activity
  • ICH and EMA E2B(R2) Mapping
    Updated mappings for the OBSERVESTUDYTYPE[A.2.3.3] element to map the following Observe Study Type values to 3 – Other Studies:
    • 4 – Patient Support Program
    • 5 – Market Research Program
    • 6 – ODCS-Digital Activity
  • E2B(R3) Mapping

    The same mapping as in E2B(R2) is applied temporarily to the OBSERVESTUDYTYPE[C.5.4] element for the E2B(R3) FDA, PMDA, MFDS, and eVAERS profiles. This interim mapping is based on the ICH Information Paper Regarding Alignment with the ICH E2D(R1) Guideline until the respective regulatory authorities confirm support for the new Observe Study type values.

Note:

Based on the latest update from the EMA, it is recommended that customers continue using the existing Observe Study Type values for EMA submissions. The new Observe Study Type values introduced as part of the ICH E2B(R3) package updates must be used only after EMA officially announces support for the new values.

Parent topic: What's new in this release