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January 2024 Production Release (Version 2) vs January 2024 Production Release (Version 3) traceability

CONCLUSION:  NO Changes as expected :

  • Just JSON file updated with correct version of MedDRA
  • x prefixes removed + file naming convention updated
  • Readme file updated with above changes as well

January 2024 Production (PUBLISHED) vs January 2025 Pre-Production Release (Version 3) traceability

CONCLUSION:  Changes as expected :

  • MDRS files updated with 2x updated records as expected
  • MedDRA map files match expected changes as provided by WCI in input files + their ReleaseStats files that come with them:

    • der2_sRefset_MedDRAtoSNOMEDSimpleMapSnapshot_INT_20240101.txt
      • 72 new/updated records + 
      • 53 records inactivated
    • der2_sRefset_SNOMEDtoMedDRASimpleMapSnapshot_INT_20240101.txt
      • 45 new/updated records + 
      • 47 records inactivated
    • CONFIRMED WITH WCI + TEAM in ISRS-7140


January 2024 Pre-Production Release (Version 2) vs January 2024 Pre-Production Release (Version 3) traceability

CONCLUSION:  Changes as expected :

  • MedDRA map files match expected changes as provided by WCI in input files + their ReleaseStats files that come with them:

    • der2_sRefset_MedDRAtoSNOMEDSimpleMapSnapshot_INT_20240101.txt
      • 72 new/updated records + 
      • 53 records inactivated
    • der2_sRefset_SNOMEDtoMedDRASimpleMapSnapshot_INT_20240101.txt
      • 45 new/updated records + 
      • 47 records inactivated


January 2024 Production (PUBLISHED) vs January 2025 Pre-Production Release (Version 2) traceability

CONCLUSION:  Changes NOT as expected - including addition of Annotations refsets + MedDRA Metadata Components, as planned

MedDRA map files DO NOT match expected changes as provided by WCI in input files:

  • der2_sRefset_MedDRAtoSNOMEDSimpleMapSnapshot_INT_20240101.txt
    • 6798 new/updated records + 
    • 53 records inactivated
  • der2_sRefset_SNOMEDtoMedDRASimpleMapSnapshot_INT_20240101.txt
    • 78 new/updated records + 
    • 78 records inactivated
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