SDTM Knowledge Base
STD · SDTMIG v3.4 REV · 2026-04 DOC · readme LANG · EN
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SDTM Pedia v1.0

SDTM Pedia is an AI-assisted knowledge base for clinical research data standards. It helps users look up CDISC SDTM variables, domains, controlled terminology, and cross-domain relationships more quickly, while keeping answers traceable to reviewable sources.

It is intended for SDTM mapping, standards lookup, variable-definition checks, domain-boundary questions, terminology review, and team training. For regulatory submissions, formal standards interpretation, and organization-level data governance, CDISC publications, controlled-terminology sources, and internal SOPs remain authoritative.

What You Can Use It For

  • Look up SDTM domains, variables, Core attributes, controlled terminology, and common cross-domain relationships.
  • Clarify boundaries between similar domains, such as LB, MB, and IS, or AE, MH, and CE.
  • Check common false premises, such as non-standard variables, deprecated domains, or an inapplicable supplemental qualifier path.
  • Ask for traceable support so a responsible person can verify the answer.
  1. User Guide: use cases, workflow, and platform choice.
  2. Platform Selection: choose an entry point based on access, sharing, and review needs.
  3. Example Questions: try representative questions.
  4. Glossary: review SDTM and clinical data standards terms.
  5. Known Limitations: understand boundaries and when to return to official sources.
  6. Methodology: review source basis, validation principles, and intended use.

Platform Entry Points

This release can be used through Claude Projects, ChatGPT GPTs, Gemini Gems, and NotebookLM. Most users only need access to an already configured instance. Administrators who need to configure or maintain an instance can use the platform-specific administrator guides.

Important Boundary

SDTM Pedia is a reference aid. It is not CDISC itself, and it does not replace medical judgment, statistical programming review, data-management SOPs, or formal quality control before submission. Any decision that affects a formal deliverable should be checked against official standards and internal procedures.