Page History

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Relationship Concrete Values files added in to match International packaging standards, as updated 2022 2022 Delta files removed, plus all MRCM + Relationship Concrete Values files added as 33069 inactivated261 added to MedDRA Full 33069 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)

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 time for 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!

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 with new refsetID + format:

> 20220131 1 816211006 1193497006

13183 changes + 1 change for header = 13184This is as expected, as there were 6464 active records (plus 0 inactive) in the April 2021 release Full file, plus 6464 inactivation records for those original records, plus the new format records activated + 0 inactivated in April 2022 = 19647

Differences found in package Comparison	Number of records impacted	Rationale
RefsetDescriptor files	0	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)
Delta files (ALL)	All	ALL 16 Delta files removed to match International packaging standards, as expected
MRCM files (x4)	All	4x MRCM files added in to match International packaging standards, as expected
Relationship Concrete Values files	All	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	43 records	inactivated 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. 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....).
MedDRA to SNOMED	Map	Snapshot files	225	137 records	added/updated, plus 85 records inactivated	MedDRA to SNOMED Map Snapshot files	13184	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	MedDRA to SNOMED Map Full files	13184	in	April	2022	=	6719	records expected in 2022.

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