Timeline:
- WIKI: https://wiki.cdisc.org/display/SDTMIG4DOT0/SDTMIG+v4.0
- Internal Review: get all content changes in before end of May 2023 if possible, but no later than June 14, Internal Review starts on June 23.
- Public Review:
- Publication:
Action Items:
Convert SuppXX datasets to NSXX datasets:
- PP: PK Parameters 2
- MB/MS
- MB/MS Example 2
- Copy of MB/MS Example 3: Questions needing resolution
- MB/MS Example 4
- MB Example 5 - Multi-target Microbial Detection/Identification Test
- Representation of multiple values in NSMB.
- IS: IS Example 11
- May need to fix NSIS pending ISMT/Supp-NS team meeting with multiple values in NS representation.
- Question for all updated examples: What to do with QORIG? values are CRF, collected, etc. They have all been removed from dataset, are they not needed anymore?
Updates to MB:
- Add new example in to IG 4.0 - Multi-target Microbial Testing Model
- Talk to ISMT/Supp_NS team about NSMB presentation - is it ok to have concatenated values or do I need to go the "MULTIPLE" route?
- Update MB assumptions:
- For typically direct assessment, see PPT to FDA.
- Add text on multiple target test.
- Update 1b and add 1c to describe how to model semi open-ended question as shown in example 5 and COVID-19 V2 TAUG - SDTM. Virus Identification 2.
Updates to MS:
- Remove MSRESCAT, this should have been done since IGv3.2.
- Create MSSTRESC codelist?
Updates to IS:
- Add www.cdisc.org rule doc and IS codetable mapping files hyperlinks into assumptions.
- Updates to assumptions?
- Remove examples? Talk to team about this.
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