Page History
...
- 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.
- 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.
- For typically direct antimicrobial assessments, see PPT to FDA.
...
Overview
Content Tools