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-2708
• SDS-2707
• SDS-2481
• SDS-2698
• SDS-2595

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
  • New 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 ( prep completed for team review)

• Add new example in to IG 4.0 - Multi-target Microbial Testing Model
• Remove MBRESCAT variable from domain spec: SDS-2536
  • Have never seen use-cases for MBRESCAT, need to consult team on whether this variable has ever been used? If no good use, remove from spec.
    • Merck: MBRESCAT is used for contaminate, infecting, colonizer and normal flora. There is an example is 3.2 and assumption 6.
    • Keep MBRESCAT in MB SPEC, no changes needed.
• Update MB assumptions, and have team review the updates: 
  • 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 ( prep completed for team review)

• Remove the MSRESCAT variable, this should have been done since IGv3.2. If not used for anything else (ask team), then this should be deprecated.
  • Controlled Terminology - Create MSSTRESC codelist? I created a codelist for team to review  
    • For this one, the results are unique to MS, so a single, unified lab-based STRESC codelist probably does not apply here?
    • Make sure to also look at request to remove MBRESCAT.
  • Related JIRA issues: SDS-2536; SDS-2534
  • MSRESCAT has been removed from the MS Spec Table
• Decisions: 1. removing MSRESCAT from Spec, but people can use it because it is a permissible variable for findings domain. 2. OK with deprecating the MSRESCAT CT codelist. 3. we will discuss where to move the existing MSRESCAT terminology. 4 check with Kathleen for removing MSRESCAT.

Updates to IS ( prep completed for team review)

• 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 
  
  • also reference the Rare Disease TAUG, and SENDIG for other examples.
  • Have the team review at WGM.
• Add www.cdisc.org IS rule doc  hyperlink into assumption 7.
• Updates to multiple assumptions. Team needs to review the updated 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.