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January

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2023 Pre-Production Release (

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Version 2) vs January

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2023 Production Release (Version

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3) traceability

Differences found in package Comparison

Number of records impactedRationale

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Readme files

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NEEDS UPDATING WITH THE NEW REFSET ID FOR MEDDRA TO SNOMED

(NB  We don't need to inactivate the old RefsetID refsetDescriptor records, as the community have always confirmed that the descriptor records should remain active even though the refset(s) in question are being inactivated)


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 impactedRationale
SNOMED to MedDRA Map Snapshot files7

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 impactedRationale
RefsetDescriptor files0

0 records changed

...

Relationship Concrete Values files

...

as expected

ModuleDependency files2

Both records

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updated to

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2023 dates, as expected 

Readme filen/a EffectiveTimes etc updated for Jan

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2023, plus all

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x prefixes added and PreProd naming conventions applied, as expected
SNOMED to MedDRA Map Snapshot files

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106

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63 records

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261 records added

In TOTAL in the 2022 Snapshot record there are 3988 records:

  • 3658 active records from 2021 (20210131 1)
  •    261 active records from 2022 (20220131 1)
  •     0 inactive records from 2021 (20210131 0)
  •  69 inactive records from 2022 (20220131 0)

This is as expected, as there were 3727 active records (plus 0 inactive) in the April 2021 release, less the 69 inactivated in April 2022 = 3658 active records expected in 2022.

...

added/updated, plus

43 records inactivated

This matches

  • the Delta file from WCI exactly

...

  • , plus
  • the stats in the WCI

...

69 records inactivated

261 records added

In TOTAL in the 2022 Snapshot record there are 4057 records:

  • 3727 active records from 2021 (20210131 1)
  •    261 active records from 2022 (20220131 1)
  •     0 inactive records from 2021 (20210131 0)
  •  69 inactive records from 2022 (20220131 0)

This is as expected, as there were 3727 active records (plus 0 inactive) in the April 2021 release, plus the 261 activated + 69 inactivated in April 2022 = 4057 records expected in 2022.

This matches the Delta file from WCI exactly (BUT NOT the stats in the WCI files - emailed WCI to see if they can get the stats working....).

...

6464  records inactivated (12928 record changes in total due to new refsetID)

6719 added in for 2022 (but 6464 of these are the old records with the new refsetID, in the new format)

  • 1x extra record removed + added because of new header (as expected)!
    • < id effectiveTime active moduleId refsetId referencedComponentId mapTarget
    • > id effectiveTime active moduleId refsetId referencedComponentId mapSource
  • 6464 active records from 2021 inactivated with old refsetID 816209002 - this takes 12928 records in total:
    • < 20210131 1 816211006 816209002 +
    • > 20220131 0 816211006 816209002
  • 6719 active records from 2022 added back in with new refsetID 1193497006:
    • > 20220131 1 816211006 1193497006
    • THIS MEANS ONLY 255 new changes for 2022?? - Donna confirmed this is roughly as expected via email at 12:44 on 22/3/22
  • 0 Inactivations from 2022 added in - is this expected??? 
    • Has the map process, perhaps, seen any new inactivations as invalid because there were no original active records from 2021 with the new refsetID 1193497006??
    • Nope, Donna checked and Nicole at MedDRA confirmed zero inactivations planned for this cycle for MedDRA-SNOMED map (see email at 14:23 on 22/3/22)

VERIFIED that using the same effectiveTime for the inactivation of the previous 6464 records is fine, as although we've got 2x records with the same effectiveTime + map pair in the snapshot files, this isn't a problem as they have new UUID's (eg)

  • 89f1dec3-96a9-500b-9231-944250255860 20220131 0 816211006 816209002 190818004 10047801
  • 7fe62b65-fa5a-5e78-a16a-1562784df08a 20220131 1 816211006 1193497006 190818004 10047801

This matches the stats in the WCI files exactly (6719 new records in 2022 Prod release), but this is to be expected as technically all those records are "new" for 2022 due to new format/refsetID.

This matches the Delta file from WCI exactly:

  • 6464 inactivations of the old 2021 refsetID records:
    • > 20220131 0 816211006 816209002
  • 6719 active records added in for 2022 with new refsetID + format:
    • > 20220131 1 816211006 1193497006
  • = 13183 changes + 1 change for header = 13184

This is as expected, as there were 6464 active records (plus 0 inactive) in the April 2021 release Snapshot, plus the 255 activated + 0 inactivated in April 2022 = 6719 records expected in 2022.

...

6464  records inactivated (12928 record changes in total due to new refsetID)

6719 added in for 2022 (but 6464 of these are the old records with the new refsetID, in the new format)

  • 1x extra record removed + added because of new header (as expected)!
    • < id effectiveTime active moduleId refsetId referencedComponentId mapTarget
    • > id effectiveTime active moduleId refsetId referencedComponentId mapSource
  • 6464 active records from 2021 inactivated with old refsetID 816209002 - this takes 6464 records in total as this is the Full file, so just leave the old records in there for historical audit trail:
    • > 20220131 0 816211006 816209002
  • 6719 active records from 2022 added back in with new refsetID 1193497006:
    • > 20220131 1 816211006 1193497006
      • THIS MEANS ONLY 255 new changes for 2022?? - Donna confirmed this is roughly as expected via email at 12:44 on 22/3/22
    • 0 Inactivations from 2022 added in - is this expected??? 
      • Has the map process, perhaps, seen any new inactivations as invalid because there were no original active records from 2021 with the new refsetID 1193497006??
      • DONNA AGREED TO ASK NICOLE from MedDRA WHETHER OR NOT THIS IS EXPECTED????
        • IF SO, AAT TO SEND MEDDRA FILES TO JANE TODAY TO SHARE WITH MEDDRA FOR REVIEW (on schedule)
        • IF NOT, AAT TO ASK RICK TO INVESTIGATE WHAT'S GOING WRONG WITH MAPPING DELTA (Nicole to provide examples of numbers + actual concepts for investigation)
      • Nope, Donna checked and Nicole at MedDRA confirmed zero inactivations planned for this cycle for MedDRA-SNOMED map (see email at 14:23 on 22/3/22)

VERIFIED that using the same effectiveTime for the inactivation of the previous 6464 records is fine, as although we've got 2x records with the same effectiveTime + map pair in the snapshot files, this isn't a problem as they have new UUID's (eg)

  • 89f1dec3-96a9-500b-9231-944250255860 20220131 0 816211006 816209002 190818004 10047801
  • 7fe62b65-fa5a-5e78-a16a-1562784df08a 20220131 1 816211006 1193497006 190818004 10047801

What IS EXTREMELY CONFUSING HOWEVER, IS THAT THE OLD ORIGINAL ACTIVE RECORDS IN THE FULL FILE ARE IN THE WRONG FORMAT!!! (ie) the MapSource is in the referencedComponentId field, and the SNOMEDID is in the mapSource column!!! (eg)

  • id effectiveTime active moduleId refsetId referencedComponentId mapSource
  • 8002f854-c572-5bb3-b508-bfa8580b0bee 20210131 1 816211006 816209002 10078111 131114008
  • 8002f854-c572-5bb3-b508-bfa8580b0bee 20220131 0 816211006 816209002 131114008 10078111

THIS NEEDS FIXING SOMEHOW!!!

Confirmed with Donna + Jane (on call on 22/3/22) that this should be fixed if possible, BUT if not possible in time for April then we can publish as it is, with a note in the Release Notes stating that a) the history will look strange, and so b) anyone needing to use the history should come and talk to us about how to do so...

**** FIXED BY HACKING PREVIOUSLY PUBLISHED FILE TO PUT THESE 6464 RECORDS INTO THE NEW FORMAT, AND RUNNING THE SRS AGAINST THIS REFINED PACKAGE!

  • "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 Name
1153567005Serum sodium below reference range (finding)nullnull10054863Serum sodium decreased
NEW MAP
1156074004Device failure (finding)nullnull10056871Device failure
NEW MAP
1156294003Lymphocyte count below reference range (finding)nullnull10025256Lymphocyte count decreased
NEW MAP
1179460004Blood magnesium below reference range (finding)nullnull10005654Blood magnesium decreased
NEW MAP
1179462007Blood urea above reference range (finding)nullnull10005851Blood urea increased
NEW MAP
1187258003Serum calcium below reference range (finding)nullnull10040174Serum calcium decreased
NEW MAP
1204394008Dilatation of urethra (disorder)nullnull10046442Urethral dilatation
NEW MAP



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 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

This matches the stats in the WCI files exactly (6719 new records in 2022 Prod release), but this is to be expected as technically all those records are "new" for 2022 due to new format/refsetID.

This matches the Delta file from WCI exactly:

  • 6464 inactivations of the old 2021 refsetID records:
    • > 20220131 0 816211006 816209002
  • 6719 active records added in for 2022 with new refsetID + format:
    • > 20220131 1 816211006 1193497006
  • = 13183 changes + 1 change for header = 13184

...