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  1. Are we using the Test Condition Agent (ISCNDAGT) variable the same as the Agent Name (MSAGENT)? Do we use them for the same purpose?
    • They both are used to map the name of the thing/entity (e.g. study/control drug, stimulating test materials like TB antigens, etc) that are added to a sample to "induce" a response.
    • The "induced" response can be stimulatory (in immune response) or inhibitory (in bacterial resistance response).
  2. If yes, do we need to merge these two variables? Seeing as we are making changes for IG4.0, this might be worth considering, and will need multiple team's review and approval.
    • This also means there would be one less standard variable out there (as people complain that there are too many new variables in IG3.4). 
  3. As a separate conversation, can we extend the use of the standard variables --CONC (Agent Concentration), --CONCU (Agent Concentration Units) to the other specimen-based domains? For mapping concentration and unit of the in vitro exposure agents? There are now use-cases needing these variables in IS, MS and CP. Right now --CONC and --CONCU are limited to MS only. They also only qualify --AGENT.
    • This way we can take advantage of existing standard variables, instead of creating new ones.
    • This also means we don't need to tell users to pre-coordinate unit and dosing concentration of the exposure agent into the same variable - which would be breaking rules.


Recommendations:

  1. We can tell Stefan to use --CONC and --CONCU for exposure agent concentration and unit, and add them to the IS domain as NSVs, because IG3.2 and SDTM 2.0 still limit these variables to the MS domain only. Meanwhile, we work on getting these variables officially added to the other domains for IG4.0 or a later version of the IG (IS, CP, maybe GF too).
  2. Or we tell Stefan to pre-coordinate all that information into the Test Condition Agent (ISCNDAGT) variable.
  3. Other thoughts? Other ways forward?