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.
• Update the ISBDAGNT variable definition to accommodate multiple antigens: 

  Text description of the agent(s) that is/are binding to the entity(ies) in the ISTEST variable. ISBDAGNT is used to indicate that there is a binding relationship between the entities in the ISTEST and ISBDAGNT variables, regardless of direction.

  ISBDAGNT is not a method qualifier. It should only be used when the actual interest of the measurement is the binding interaction between the 2 entities in ISTEST and ISBDAGNT. In other words, the combination of ISTEST and ISBDAGNT should describe the entity or the analyte being measured, without the need for additional variables.

  The binding agent may be (but is not limited to) a test article, a portion of the test article, a related compound, an endogenous molecule, an allergen, or an infectious agent.