SDTM Knowledge Base
STD · SDTMIG v3.4 REV · 2026-04 DOC · methodology LANG · EN
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Methodology and Validation Statement

This page summarizes the source basis, validation principles, and intended use of SDTM Pedia v1.0. It is written for users who need to understand the trust basis, not for internal engineering review.

1. Source Basis

The knowledge base is organized around official CDISC SDTM materials, including SDTMIG, the SDTM Model, and CDISC Controlled Terminology. Content involving medical coding or external terminology systems should also be checked against the relevant licensed source and internal process.

This project does not republish CDISC standards as authoritative originals, and it does not treat third-party summaries as the source of truth. Formal standards decisions should be checked against official publications.

2. Construction Principles

The knowledge base follows these principles:

  • Use official standards as the primary basis.
  • Preserve traceability among domains, variables, controlled terminology, and sections.
  • State boundaries for content that cannot be fully expanded or requires real-time external lookup.
  • Treat common false premises cautiously rather than filling gaps without support.
  • Separate user-facing explanation from internal construction records.

3. Validation Approach

v1.0 was checked with questions covering variable definitions, Core attributes, controlled terminology, domain boundaries, cross-domain relationships, and common false premises. The purpose is not to prove that the tool replaces human review; it is to confirm that common SDTM lookup scenarios produce supported, reviewable, boundary-aware answers.

For formal work, use the following pattern:

  1. Use SDTM Pedia to obtain a candidate answer and support.
  2. Check CDISC publications, controlled terminology sources, or project standards.
  3. Put the final decision through your internal QC, review, and approval workflow.

4. Intended Use

Appropriate uses include:

  • SDTM learning and training.
  • Standards lookup before mapping.
  • Initial checks of variables, domains, and controlled terminology.
  • Explanation of cross-domain relationships and common boundary questions.

Do not use it alone for:

  • Final standards decisions before regulatory submission.
  • Final medical coding decisions.
  • Replacing statistical programming, data management, or standards governance review.
  • Determining external information that changed after the release.

5. Responsibility Boundary

SDTM Pedia is an aid. Users should choose the depth of review according to the risk of the use case. Anything affecting a formal submission, patient safety, medical interpretation, or regulatory communication should be confirmed by responsible personnel under the organization’s process.