SDTM Knowledge Base
STD · SDTMIG v3.4 REV · 2026-04 DOC · deploy-claude LANG · EN
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Claude Project Administrator Guide

This guide is for administrators who need to configure or maintain an SDTM Pedia Claude Project. Most end users only need access to a Project that has already been configured by their team.

When To Use This Guide

  • Your team needs a shared entry point for more complex SDTM standards lookup.
  • You want to maintain one approved SDTM Pedia instance in Claude Projects.
  • You need to add the release package knowledge files and project instructions to Claude.

Prerequisites

  • An account and organization role that can create Claude Projects.
  • Access to this release package’s system_prompt.md and uploads/ folder.
  • Confirmation that your organization permits the relevant materials to be used in Claude under its data-security requirements.

Deployment Steps

  1. Create a new Project in Claude.
  2. Paste the full contents of system_prompt.md into Project instructions.
  3. Upload all 19 Markdown files from uploads/ to Project knowledge.
  4. Save the Project and set its name, description, and access permissions.
  5. Use a few standard questions to confirm that variable definitions, domain boundaries, and cross-domain explanations work as expected.

Suggested Name

Recommended:

SDTM Pedia - Internal Reference

The description should state that this is an SDTM standards lookup aid and does not replace CDISC publications or internal SOPs.

Basic Verification

After deployment, confirm that it can:

  • Explain key AE-domain variables and their usage attributes.
  • Distinguish common domain boundaries such as LB, MB, and IS.
  • Treat non-standard variables or datasets cautiously.
  • Provide reviewable support in its answer.

If answers are off, first check that Project instructions are complete, all 19 knowledge files were uploaded, and filenames were not changed.

Team Sharing

Before sharing, confirm:

  • Who can access the Project.
  • Who can modify instructions or knowledge files.
  • Whether project-confidential, patient-level, or non-deidentified data are prohibited.
  • Whether users need a short usage-boundary note.

Limit edit access to a small number of maintainers to avoid accidental configuration changes.

Maintenance

  • Create an administrator test Project before updating the official instance.
  • After verification, replace the instructions or knowledge files in the official instance.
  • Keep an update record with date, maintainer, change summary, and basic verification result.

Boundary of Use

The Claude Project instance is an SDTM lookup and explanation aid. Formal submissions, medical coding, project-level mapping, and quality control still require responsible review under your organization’s process.