Timeline:

• WIKI: https://wiki.cdisc.org/display/SDTMIG4DOT0/SDTMIG+v4.0
• Internal Review:

  • - The majority of the content updates (major changes: new examples, example/assumptions/new variables updates etc.) should be uploaded into the SDTMIG v4.0 before Oct 1, 2023. 
    - Oct 2023 to end of Jan 2024 = minor issues fixes/updates, absolutely NO major/big content changes. 
    - IR starts Feb 2024.

• 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

• MI:
  • MI Example 2
  • MI Example 3
• 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.
    • Send the new NSVs to Rebecca and review with the NSV Registry team, they need to be added before IR. Wait a few days to see if Craig and Chris would respond.
    • Review NSVs with Rebecca's team.
• IS: IS Example 11
  • Send NSV to Rebecca and add to NSV Registry
  • Review NSVs with Rebecca's team.
• 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
• Update MB assumptions:
  • For typically direct antimicrobial assessments, 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

• Update this example and add in the second dataset on alternative modeling: IS Example 10
• Add a new example for the vector based vaccine use case: anti-vector ab vs vaccine-induced antibody: Viral Vector Vaccine.xlsx
  • once done, send to team for a quick look.
  • also reference the Rare Disease TAUG, section for another example.
• Add www.cdisc.org rule doc and IS codetable mapping files hyperlinks into assumptions.
• Updates to assumptions?
• Remove examples? Talk to team about this.