January 2025 Production Release (Version 1) vs January 2025 Production Release (Version 5) traceability

CONCLUSION:  NO Changes as expected :

• Just file naming convention updated for Association files + Readme file updated with above changes as well

January 2025 Pre-Production Release (Version 3) vs January 2025 Production Release (Version 1) traceability

CONCLUSION:  NO Changes as expected :

• x prefixes removed

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