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Team Final Recommendations/Decisions:

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.

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

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