Traceability matrix - MedDRA (April 2023)

Traceability matrix - MedDRA (April 2023)

January 2023 Pre-Production Release (Version 2) vs January 2023 Production Release (Version 3) traceability

Differences found in package Comparison

Number of records impacted

Rationale

Differences found in package Comparison

Number of records impacted

Rationale

Readme files



All x prefixes removed, and Production naming conventions applied

January 2023 Pre-Production Release (Version 1) vs January 2023 Pre-Production Release (Version 2) traceability

Differences found in package Comparison

Number of records impacted

Rationale

Differences found in package Comparison

Number of records impacted

Rationale

SNOMED to MedDRA Map Snapshot files

7

7 records added to fix reported issue:

> 210c83a1-6069-54e1-8765-ccd9543ae244    20230131    1    816211006    816210007    1187258003    10040174
> 2887cfa2-592d-5301-9c62-6951a8d62d47    20230131    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



January 2022 Production (PUBLISHED) vs January 2023 Pre-Production Release (Version 1) traceability

Differences found in package Comparison

Number of records impacted

Rationale

Differences found in package Comparison

Number of records impacted

Rationale

RefsetDescriptor files

0

0 records changed as expected

ModuleDependency files

2

Both records updated to 2023 dates, as expected 

Readme file

n/a 

EffectiveTimes etc updated for Jan 2023, plus all x prefixes added and PreProd naming conventions applied, as expected

SNOMED to MedDRA Map Snapshot files

106

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.  




This 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.

 

MedDRA to SNOMED Map Snapshot files

225

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

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