ChatGPT GPT Administrator Guide

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

When To Use This Guide

• Your team needs a shared SDTM lookup entry point.
• You want to maintain one organization-approved GPT configuration.
• You need to add SDTM Pedia knowledge files to a custom GPT.

Prerequisites

• A ChatGPT account or organization role that can create custom GPTs.
• Access to this release package’s system_prompt.md and uploads/ folder.
• Awareness of your organization’s AI tool, data security, and sharing policies.

Deployment Steps

1. Create a new custom GPT in ChatGPT.
2. Paste the full contents of system_prompt.md into the Instructions area.
3. Add all 9 Markdown files from uploads/ to the Knowledge area.
4. Save the GPT and set its name, description, and access permissions according to your organization’s policy.
5. Use a few standard questions to confirm that the instance can answer SDTM variable, domain-boundary, and controlled-terminology questions.

Suggested Name

Use a clear, non-misleading name, for example:

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 at minimum that it can:

• Explain the meaning, Core attribute, and controlled terminology for AESER.
• Distinguish appropriate use cases for LB, MB, and IS.
• Treat non-existent or non-applicable premises cautiously instead of inventing unsupported answers.

If answers are clearly off, first check that the Instructions are complete, all 9 knowledge files were uploaded, and the sharing settings were saved.

Team Sharing

Before sharing, confirm:

• Whether access is limited to team members.
• Who can edit the GPT configuration.
• Whether users are prohibited from entering project-confidential, patient-level, or non-deidentified data.
• Whether a usage-boundary note should be included for the team.

Give edit access only to a small number of maintainers; most users should have use-only access.

Maintenance

• Test updates in an administrator copy before replacing the team instance.
• Record the update date, maintainer, and summary of changes.
• If a standards-content issue is found, check CDISC official sources before updating the release package.

Boundary of Use

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