Versions Compared

Old Version 19

changes.mady.by.user Jordan Li

Saved on

compared with

New Version 20

changes.mady.by.user Jordan Li

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  1. This was sent to the lab team for discussion and we decided that the INF-y response tests should be modeled in IS (as agreed to with the same TB TAUG INF-y response tests here: https://wiki.cdisc.org/x/azXFBg).
  2. Craig said mentioned that there are NO other variables to capture the units and dosing concentrations for the test agents that are added to the samples. In fact, this is a gap in the CDISC model that we lack variables (or a domain) to help mapping in vitro drug/non-drug exposure data. The EX/EC and AG domains are used for mapping in vivo drug and non-drug agents exposure data (respectively) in SDTM. These domains have variables for mapping dosing concentrations and units, but we can 't use them NOT use EX/EC/AG for in vitro exposure data. Craig said he would (Diane W confirmed). In light of this, one option is to pre-coordinate the concentrations and dosing units of the added agents into the ISCNAGT (test condition agent) variable, see the texts in red in the above example.
    • This is a problem because a single CDISC variable should be designed for a single meaning and a single purpose. The Test Condition Agent variable is used for the name/identity of the added study/control drugs or other materials. I think we would be breaking rules to also include the concentration and unit in this variable as well.
  3. While brain storming Stefan's use-case, I remembered that in the MS domain, there are MSAGENT (Agent Name), MSCONC (Agent Concentration), MSCONCU (Agent Concentration Units) variables that were added back in SDTMIG v3.2 to represent the study and control drugs used for microbial resistance testing. The 3 variables, MSAGENT, MSCONC, and MSCONCU are used to map the name of the study/control drugs, their concentrations and units respectively. Basically, for these MS tests, you dump study drugs, likely an antibiotic (at varying concentrations) on a plate to see if the bacteria would be resistant or susceptible for the drug by measuring a few specific outputs. Below is a MS example from IG3.4 to show how the 3 variables are used together with the MSTESTs:

...