MFDS E2B(R3) updates

Summary

MFDS E2B(R3) updates (Enhancements 36373010, 32685700, and 35616714)

Description

The mappings and validations for MFDS E2B(R3) are updated based on the MFDS verification rules published on 17-Oct-2023, 18-Jan-2024, and 24-Jan-2024.

Mappings of the following elements are updated:
  • PATIENTBIRTHDATER3[D.2.1]
  • PATIENTONSETAGE[D.2.2a]
  • GESTATIONPERIOD[D.2.2.1a]
  • PATIENTAGEGROUP[D.2.3]
Validations of the following elements is updated:
  • Handling future dates:
    • RECEIVEDATER3[C.1.4]
    • RECEIPTDATER3[C.1.5]
  • MedDRA currency:
    • PATIENTEPISODENAME[D.7.1.r.1b]
    • PATIENTDRUGINDICATION[D.8.r.6b]
    • PATIENTDRUGREACTION[D.8.r.7b]
    • PATIENTDEATHREPORT[D.9.2.r.1b]
    • PATIENTDETERMINEAUTOPSY[D.9.4.r.1b]
    • PARENTMEDICALEPISODENAME[D.10.7.1.r.1b]
    • PARENTDRUGINDICATION[D.10.8.r.6b]
    • PARENTDRUGREACTION[D.10.8.r.7b]
    • REACTIONMEDDRALLT[E.i.2.1b]
    • TESTNAMELLT[F.r.2.2b]
    • DRUGINDICATIONMEDDRACODE[G.k.7.r.2b]
    • SENDERDIAGNOSISMEDDRACODE[H.3.r.1b]
  • Other validations:
    • SENDERCITY[C.3.4.2]
    • SENDERSTATE[C.3.4.3]
    • SENDERPOSTCODE[C.3.4.4]
    • PATIENTMEDICALPRODUCTID[D.8.r.1.KR.1b]
    • PARENTMEDICALPRODUCTID[D.10.8.r.1.KR.1b]
    • DRUGMEDICALPRODUCTID[G.k.2.1.KR.1b]
    • SUBSTANCEID[G.k.2.3.r.1.KR.1b]

For more details, refer to ArgusInterchange844_E2B(R3) Export Mappings.