Page History

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•  SDS-2536
•  SDS-2534
•  SDS-2708
•  SDS-2707
•  SDS-2481
•  SDS-2698
•  SDS-2595

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•  MI:
  •  MI Example 2
  •  MI Example 3
•  PP: PK Parameters 2
•  MB/MS
  
  •  MB/MS Example 2
  •  Copy of 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?

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•  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.  

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•  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.

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