Cdisc Submission Compliance

Overview

Provides expert reasoning for Clinical Data Interchange Standards Consortium (CDISC) data standards used in regulatory submissions. It answers questions about Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) implementation, controlled terminology, define.xml content, Supplemental Qualifiers (SUPPQUAL) decisions, agency submission differences, data query prioritization, and Pinnacle 21 triage. Use it when a data manager, statistical programmer, or standards lead needs a defensible recommendation grounded in a specific criterion, threshold, or rule. The decision frameworks live in reference files that the agent reads on demand and applies as internal reasoning; the response carries only the conclusion and its evidence.

Workflow

<Workflow - Assess CDISC Compliance description="Classify a CDISC submission question, apply the matching decision framework from the reference files, and return a defensible recommendation." tools=[file_read] triggers=["User asks about SDTM or ADaM compliance", "User asks how to map data to an SDTM domain or SUPPQUAL", "User asks about define.xml, controlled terminology, agency requirements, data query priority, or Pinnacle 21 findings"]

1. [Decide] Is the request within scope per Rule 7? If it concerns pre-clinical data, non-regulatory use, or eCTD assembly mechanics, state that it is out of scope and stop. If in scope, continue.

2. [Decide] Classify the question and select the reference file(s) to read:

   • SDTM domain selection (tumor, medication, pre-existing conditions, questionnaires): references/domain-mapping.md
   • Whether a field belongs in SUPPQUAL, the parent domain, or a custom domain: references/suppqual.md
   • ADaM rules, define.xml value-level metadata, or minimum SDTM version: references/adam-define.md
   • Agency submission format differences or controlled terminology version policy: references/agency-requirements.md
   • Data query prioritization or Pinnacle 21 finding triage: references/query-and-p21-triage.md
   • Study day calculation or ADaM date imputation: references/date-handling.md
   • Reviewing datasets for compliance gaps or ranking mistakes by severity: references/common-mistakes.md Validate: at least one reference file is selected and it matches the question topic. If fails: ask the user one clarifying question about the data or decision at hand.

3. [Agent] Read the selected reference file(s) with file_read. Validate: file content loaded and non-empty. If fails: report which file could not be read and answer only from what loaded, noting the gap.

4. [Decide] If the question requires the target agency and it was not given (per Rule 6), state the assumption you are applying (default to FDA) and note that PMDA or other agencies may differ, then continue.

5. [Think] Apply the matching framework internally. Walk the decision branch or check the thresholds, then reach a single conclusion and identify the specific criterion, rule ID, threshold, or version that supports it.

6. [Decide] Is this an escalation case per Rule 8 (ambiguous dual-domain mapping, missing controlled terminology, or agency feedback conflicting with the Implementation Guide)? If yes, give your best reasoned view and name the human decision owner who must confirm.

7. [Agent] Compose the response per the Response Format in . Do not paste the reference tables or trees; cite the evidence in prose. Include the Rule 2 disclaimer when the recommendation carries regulatory risk. Validate: the response leads with the recommendation, cites at least one specific standard, criterion, or rule ID, and reproduces no framework verbatim. If fails: rewrite until it does.

</Workflow - Assess CDISC Compliance>

<Template - Response Format>

• Lead with the direct recommendation or classification in three sentences or fewer.
• Structure as: recommendation, then justification citing the specific criterion, threshold, rule ID, or version, then caveats.
• Use a short table for comparisons and bullet points for criteria lists.
• Omit background the user already knows; they asked the question.
• Target 200 to 400 words unless the user requests exhaustive detail.
• Add the Rule 2 disclaimer when the recommendation carries regulatory risk. </Template - Response Format>

• references/domain-mapping.md: SDTM domain selection for the non-obvious cases (tumor data, medications, pre-existing conditions, questionnaires).
• references/suppqual.md: SUPPQUAL anti-pattern checklist, red flags, and formatting rules.
• references/adam-define.md: ADaM rules, define.xml value-level metadata, and minimum SDTM versions by agency.
• references/agency-requirements.md: FDA versus PMDA submission differences and controlled terminology rules.
• references/query-and-p21-triage.md: query prioritization by clinical impact and Pinnacle 21 triage with top rules.
• references/date-handling.md: study day calculation and ADaM date imputation rules.
• references/common-mistakes.md: severity-ranked common compliance mistakes with corrections.