cdisc-org / cdisc-org/cdisc-rules-engine

As RULE ENGINE, I need to access a list of FDA-desired trial summary parameters (TSPARM) specified in their Technical Conformance Guide (TCG) so that I can perform this kind of FDA recommended data quality check.

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FDA Business rules question
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Description

Background:
1. FDA owns and publishes the TCG.
2. A new version of TCG automatically overrides its predecessor.
3. As of v5.7 published March 2024, this information of desired TSPARM can be found in Appendices B and C. Two lists are available, separated by clinical and non-clinical submission use cases. This information is unstructured text in a PDF file format document.
4. There are no known equivalent recommendations from PMDA.

Perceived use:
1. CDISC will update and maintain the information followed each TCG revision.
2. USER may amend the information to meet the uniqueness in each of their submissions. Ref: "Sponsors may use additional TS Parameters not listed in the table below if they are needed to describe the trial." TCG v5.7.
3. CDISC will write one CORE rule, e.g., The TS dataset does not meet all the FDA desired parameters, as specified in, e.g., `my_fdatcg_tsparm_spec.yaml`.

Outstanding questions:
1. Do we need to evaluate TSGRPID's role for each parameter listed in the Appendices?
2. How do we manage the release of this resource in the future? Note that there is no set publication cadence for TCG revisions.

Draft acceptance criteria:
1. A structured, machine-readable representation of information in said TCG appendices, especially conditions in the FDA Notes column.
3. This information is a separate resource file, in YAML format.
4. This resource file should contain an attribute that describes the TCG version.
5. The engine will output error messages contextualized to each TSPARM, not a generic message.
6. The engine will need to know which submission use case (e.g., clinical, non-clinical, tobacco) so that the correct set of parameter specifications is used.

Contributor guide

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