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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.

Team Final Recommendations/Decisions:

  1. 1.We need a variable to map the added agent: drug, diagnostic agents, other substances (used to induce a in vitro response). Sometimes this is all we need, and the dataset stops here.

    • There are two variables now serving the same function: CNDAGT and AGENT. – Yes true, but that ship had sailed, we can't do much at this point without causing significant changes.
    • Can we merge them? One less variable people have to worry about. – No to this one because the kind of changes required to replace AGENT (MS) is too large and not worth people going back to fix their data. The --CNDAGT variable can be available for all the other specimen-based domains when needed, we will add --CNDAGT to domains that require it when use-cases arise. --CNDAGT (per SDTM2.0) is limited to IS, LB and CP for now. We also need to add an assumption to the MS domain (for IG4.0) to say that because we will keep AGENT in MS, people should not use CNDAGT in MS. They serve the same purpose so using both will create a contradiction.

    2.We need a variable for the agent concentration.

    • MSCONC works but this is limited to MS.
    • Expand it to other specimen-domains, no need to create new variable. – Yes, we agree to extend --CONC to other domains. Meanwhile people can use it as a NSV for their respective domains if they are using IG3.2-3.4. We may aim for IG4.0 for this change. If ISMT/GGG agrees, we need to update the variable Role, Notes and Definition so that it qualifies --CNDAGT as well. Also CONC is already a standard variable, we can just take advantage of it.

    3.We need a variable for the agent dosing unit.

    • MSCONCU works but this is limited to MS.
    • Expand it to other specimen-domains, no need to create new variable. – Yes, we agree to extend --CONCU to other domains. Meanwhile people can use it as a NSV for their respective domains if they are using IG3.2-3.4. We may aim for IG4.0 for this change. If ISMT/GGG agrees, we need to update the variable Role, Notes and Definition so that it qualifies --CNDAGT as well. Also CONCU is already a standard variable, we can just take advantage of it.
  2. 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).
  3. Or we tell Stefan to pre-coordinate all that information into the Test Condition Agent (ISCNDAGT) variable, or create his own NSV for concentration and unit of the agent.
  4. Other thoughts? Other ways forward?


If we extend CONC and CONCU to other specimen domains...

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