SDTMIG v4.0 To-Do List

Timeline:

• WIKI: https://wiki.cdisc.org/display/SDTMIG4DOT0/SDTMIG+v4.0
• Get all content changes in before end of May if possible, but no later than June 14, Internal Review starts on June 23

Action Items:

Convert SuppXX datasets to NSXX datasets:

• PP
• MB/MS
  • Questions open on: 
• 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.