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January

2023

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

View file
nameCOMPARISON RESULTS (Apr24PreProdVersion2 vs Apr24PreProdVersion3).pdf
height250

CONCLUSION:  NO Changes as expected :

  • Just JSON file updated with correct version of MedDRA

January 2024 Pre-Production Release (Version

2

3) vs January

2023

2024 Production Release (Version

3

2) traceability

Differences found in package Comparison

Number of records impactedRationaleReadme files

All x prefixes removed, and Production naming conventions applied

View file
nameComparison results (Apr24PreProdVersion3 vs Apr24ProdVersion2).pdf
height250

CONCLUSION:  Changes as expected :

  • x prefixes removed + file naming convention updated
  • Readme file updated with above changes as well


January 2024

January 2023

Pre-Production Release (Version

1

2) vs January

2023

2024 Pre-Production Release (Version

2

3) traceability

Differences found in package Comparison

Number of records impactedRationaleSNOMED to MedDRA Map Snapshot files7

View file
nameComparison results (Apr24PreProdVersion2 vs Apr24PreProdVersion3).pdf
height250

CONCLUSION:  Changes as expected :

  • OWLExpression record had its UUID updated to match the INT Edition record, to ensure continuity of data:
    • < c0d051d1-c830-4d0c-add8-772c8b4d42a8    20240101

7 records added to fix reported issue:

> 210c83a1-6069-54e1-8765-ccd9543ae244    20230131
    •    1    816211006  
 816210007
    •  733073007  
 1187258003    10040174
    •  816211006    SubClassOf(:816211006 :900000000000445007)
    • >
2887cfa2
    • 864e67df-
592d
    • 6999-
5301
    • 4aa8-
9c62
    • 819c-
6951a8d62d47
    • c4807b54ce6c  
 20230131
    •  20240101    1    816211006  
 816210007    1179462007    10005851
> 5e09946b-25c8-5a83-bdec-6f65654c2d04    20230131    1    816211006    816210007    1153567005    10054863
> 5ee89a5f-bb7a-5a1e-84b9-6e65d6f3dea8    20230131    1    816211006    816210007    1156294003    10025256
> 86d0f57d-dff7-5c10-8937-538921c23236    20230131    1    816211006    816210007    1156074004    10056871
> b4dcd04f-03d5-5f52-bf0a-adbb5c088832    20230131    1    816211006    816210007    1179460004    10005654
> dcc66a8e-042d-5478-b234-35131e3d63b3    20230131    1    816211006    816210007    1204394008    10046442
    •  733073007    816211006    SubClassOf(:816211006 :900000000000445007)
  • Inferred Relationship record from the INT Edition added as expected, to complete the transition of Metadata over to the Derivative package:
    • > 12135838028    20240101    1    816211006    816211006    900000000000445007    0    116680003    900000000000011006    900000000000451002


January 2023

January 2022

Production (PUBLISHED) vs January

2023

2024 Pre-Production Release (Version

1

2) traceability

Differences found in package Comparison

Number of records impactedRationaleRefsetDescriptor files0

0 records changed as expected

ModuleDependency files2

Both records updated to 2023 dates, as expected 

Readme filen/a EffectiveTimes etc updated for Jan 2023, plus all x prefixes added and PreProd naming conventions applied, as expectedSNOMED to MedDRA Map Snapshot files106

63 records added/updated, plus

43 records inactivated

This matches

  • the Delta file from WCI exactly, plus
  • the stats in the WCI "Meddrastats.txt" files:
    • added/updated should match TOTAL of "Total Changed mapped entries (new) this release" + "Total New mapped entries this release" counts in the WCI Stats files
    • inactivated should match TOTAL of "Total Changed mapped entries (retired) this release" + "Total Retired mapped entries this release" counts in the WCI Stats files

Just need to ask Donna for manual confirmation when we send the PreProd release out for review.

Donna + Rick confirmed correct

BUT THEN REPORT FROM MedDRA review confirmed 7 missing records (see email trail from 19/04/2023 at 20:20:

  1. Detail for count difference SNOMED to MedDRA - Adds (59 in PreProduction Report) vs New Map (66 in MedDRA Change Report):  
    Per 'MedDRA Change Report' the below are included as 'New Map' but these are not included in PreProduction Report as Adds.  

Source Concept IdSource Concept NameNotesQA CheckNew Target IdNew Target NameOld Target IdOld Target Name1153567005Serum sodium below reference range (finding)nullnull10054863Serum sodium decreasedNEW MAP1156074004Device failure (finding)nullnull10056871Device failureNEW MAP1156294003Lymphocyte count below reference range (finding)nullnull10025256Lymphocyte count decreasedNEW MAP1179460004Blood magnesium below reference range (finding)nullnull10005654Blood magnesium decreasedNEW MAP1179462007Blood urea above reference range (finding)nullnull10005851Blood urea increasedNEW MAP1187258003Serum calcium below reference range (finding)nullnull10040174Serum calcium decreasedNEW MAP1204394008Dilatation of urethra (disorder)nullnull10046442Urethral dilatationNEW MAPThis is a valid finding.  These were mapped after the original release files were created, and Donna identified there were 7 additional concepts that needed mapping.  This suggests that the older file was used to create this release package and not the updated one.
@Andrew Atkinson - can you please load the SNOMED to MedDRA Delta file that I sent on March 2nd?  It is identical to the previous file, except that it includes these 7 additional maps.
 

View file
nameCOMPARISON RESULTS (Apr23ProdPublished vs Apr24PreProdVersion2).pdf
height250

CONCLUSION:  Changes as expected - including addition of Annotations refsets + MedDRA Metadata Components, as planned

MedDRA map files match expected changes as provided by WCI in input files:

  • der2_sRefset_MedDRAtoSNOMEDSimpleMapSnapshot_INT_20240101.txt
    • 61 new/updated records + 
    • 53 records inactivated
  • der2_sRefset_SNOMEDtoMedDRASimpleMapSnapshot_INT_20240101.txt
    • 78 new/updated records + 
    • 78 records inactivated
MedDRA to SNOMED Map Snapshot files225

137 records added/updated, plus

85 records inactivated

This matches

  • the Delta file from WCI exactly, plus
  • the stats in the WCI "snomedctstats.txt" files:
    • added/updated should match TOTAL of "Total Changed mapped entries (new) this release" + "Total New mapped entries this release" counts in the WCI Stats files
    • inactivated should match TOTAL of "Total Changed mapped entries (retired) this release" + "Total Retired mapped entries this release" counts in the WCI Stats files

Just need to ask Donna for manual confirmation when we send the PreProd release out for review.

Donna + Rick confirmed correct