Open chowsanthony opened 1 month ago
Perceived Use #3: I think it would be "CDISC will write a set of CORE rules, ...".
Draft acceptance criteria #5: I think we need to add "Assumption: a Define-XML v2.1 document is expected for appropriate implementation of the TCG related rules.".
Draft acceptance criteria #2: "This information is a separate resource file" could be stated in a more generic way "This information is a separate set of resource file(s)".
I would add: Draft acceptance criteria #2.1: The engine will include functionality to handle this type of information resource as a reference resource where all its keys/value pairs could be queried by the user.
Draft acceptance criteria #4: I would say that this criteria is not for the engine, instead it corresponds to how each rule is designed.
We probably should and could apply this to Trial Set parameters (TXPARM). Excerpt from TCG:
The Trial Sets domain (TX) should be submitted for each study. Every set in the TX domain should have only one record with each of the following TXPARMCD values: SPGRPCD (sponsor group code associated with the set), GRPLBL (sponsor group label associated with the set), PLANMSUB (planned number of males in set), and PLANFSUB (planned number of females in set). There should be a one-to-one correspondence between GRPLBL and SPGRPCD entries in the TX domain.
Background:
Perceived use:
my_fdatcg_tsparm_spec.yaml
.Outstanding questions:
Draft acceptance criteria: