Page History

...

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

...

•  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 new NSVs to Rebecca and review with the NSV Registry team, they need to be added before IR.
•  IS: IS Example 11
  •  Send NSV to Rebecca and add to NSV Registry
•  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?

...

•  Add new example in to IG 4.0 - Multi-target Microbial Testing Model
•  Update MB assumptions:
  •  For typically direct assessmentantimicrobial 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.

...