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
- MB/MS
- Questions open on: Copy of MB/MS Example 3
- IS
- May need to fix NSIS pending ISMT meeting with multiple values NS representation.
Updates to MB:
- Add new example in to IG 4.0 - Multi-target Microbial Testing Model
- Talk to ISMT 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.
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.
Overview
Content Tools