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:

Open JIRA Issues for IG4.0

IS Domain

•  SDS-2699
•  SDS-2599
•  SDS-2594
•  SDS-2592
•  SDS-2591
•  SDS-2576
•  SDS-2575
•  SDS-2563
•  SDS-2553

MB/MS Domains

•  SDS-2536
•  SDS-2534
•  SDS-2698
•  SDS-2698

PC/PP Domains

•  SDS-2505

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. Checked with Diane, all ok, does not break any rules.
•  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?
  •  Related JIRA issues: SDS-2536; SDS-2534

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.

...