Page History

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Convert SuppXX datasets to NSXX datasets:

•  PP: PK Parameters 2
•  MB/MS
  
  •  MB/MS Example 2
  •  Questions open on: 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.
•  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.

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