SDTM Knowledge Base
STD · SDTMIG v3.4 REV · 2026-04 DOC · deploy-gemini LANG · EN
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Gemini Gem Administrator Guide

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

When To Use This Guide

  • Your team wants an SDTM lookup entry point in Gemini.
  • You need to maintain one approved Gem configuration.
  • You need to add the release package instructions and knowledge files to a Gemini Gem.

Prerequisites

  • A Google account or Workspace role that can create and configure Gemini Gems.
  • Access to this release package’s system_prompt.md and uploads/ folder.
  • Confirmation that your organization permits the relevant materials to be used in Gemini under its data-security requirements.

Deployment Steps

  1. Create a new Gem in Gemini.
  2. Paste the full contents of system_prompt.md into Gem instructions.
  3. Add the 4 Markdown files from uploads/ as knowledge files.
  4. Save the Gem and set its name, description, and sharing permissions.
  5. Use a few standard questions to confirm that variable definitions, domain boundaries, and cross-topic 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 the meaning and usage attributes of AESER.
  • Distinguish appropriate use cases for LB, MB, and IS.
  • Treat deprecated concepts or non-existent variables cautiously.
  • Provide reviewable support in its answer.

If answers are clearly off, first check that instructions are complete, all 4 knowledge files were added, and sharing settings are correct.

Team Sharing

Before sharing, confirm:

  • Whether access scope follows organization policy.
  • Who can edit the Gem.
  • Whether project-confidential, patient-level, or non-deidentified data are prohibited.
  • Whether users need a short usage-boundary note.

Keep configuration management with a small number of maintainers; most users should only use the Gem.

Maintenance

  • Create an administrator test Gem before updating the official instance.
  • After verification, update the official instance.
  • Record update date, maintainer, change summary, and basic verification result.

Boundary of Use

The Gemini Gem 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.