Page History

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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.
•  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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•  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 udpated assuptionsupdated 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.

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