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Ground Rules for Examples; examples must be:

  • "Real-life" submission use cases (i.e., not theoretical)
  • Should be actual dummied collection if possible; otherwise other materials are fine.
Row #TopicUse CaseDomains AffectedExample/DecisionsModelingNotes
1Updates from Influenza-TAUG
OI, ISHemagglutination Inhibition Assay - updates from Influenza-TAUGCompleted
for Examples
2Updates from TB-TAUG v1 and v2
ISInterferon-Gamma Response Assays -updates from TB-TAUG V1 and V2Completed
  • Added to
Examples for
3Antinuclear Antibody Staining 
ISOpen-ended Findings vs Pre-specified Findings Modeling in ISCompleted
for Examples
4High-Risk HPV Screening Test
MBModeling Multi-target Microbial Detection/Identification TestCompleted
for Examples
5Replication Complement Lentivirus
MBReplication Competent Lentivirus - Decisions

Example not needed in MB.

May be

Maybe needed in GF? There is a similar request to GF.

  • GF team has a similar topic, need to notify Chris that the MB team has created controlled terminology for this topic and the decision
it
6System Serology Data
ISSystem Serology Examples

7Updates from Influenza-TAUG
MBFlu Antigen Identification Tests

8

HLA Allele Antibodies

HLA Typing

  1. HLA-DPA1*01:03 Allele Antibody
  1. ; HLA-DPB1*04:01 Allele Antibody
  1. ; HLA-DPB1*04:01 Allele Antibody
  1. ; HLA-DPB1*04:01 Allele Antibody
  2. We need to move the HLA Antigen/Antibody Typing and Mismatch Examples from LB to IS. Re-evaluate examples from Kidney Transplant-TAUG (section 3.2).



IS

  • The antibodies targeting HLA antigens belong in IS, like HLA-A32 Antibody, HLA-DQB5 Antibody, but what are these
things?
  • allele antibodies? Need to follow up with requesters.
  • Need to move the HLA Antigen/Antibody Typing data, and HLA Mismatch data  from LB into IS. 
    • The PF data for HLA typing will be updated by the GF team, probably.
  • GF team has a similar topic, need to work with Chris to see which team/domain this data fall under.
  • Genomics Example Collections Planning
  • Action: Inform Christine Connolly : done.
  • 2023-05 (CDISC WGM): Team agree that tissue typing data should be modeled in IS. Jordan to start moving the HLA typing data from LB to IS.