eTMF Compliance Gap Analysis

Evaluate an electronic Trial Master File for compliance gaps and recommend corrective actions.

View Source YAML

---
name: eTMF Compliance Gap Analysis
version: 0.1.0
description: Evaluate an electronic Trial Master File for compliance gaps and recommend corrective actions.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - quality
  - tmf
  - compliance
  - gap
  - analysis
  requires_context: true
variables:
- name: etmf_export
  description: Excel export of the eTMF
  required: true
- name: study_id
  description: The study id to use for this prompt
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a Clinical Quality Specialist at a global CRO. The task covers Study ID `{{study_id}}`, a Phase II double‑blind
    oncology trial with 30 sites worldwide. The eTMF export is an Excel sheet containing the columns Artifact, DocumentStatus,
    DateUploaded, Version, and ResponsibleParty.


    Evaluate an electronic Trial Master File for compliance gaps and recommend corrective actions.'
- role: user
  content: '1. Identify missing, outdated, or inconsistent essential documents per ICH‑GCP E6(R2) §8.

    1. Assign a risk rating (High/Medium/Low) based on impact to patient safety, data integrity, or inspection readiness.

    1. Propose a corrective action for every High‑ and Medium‑risk gap.


    Inputs:

    - `{{etmf_export}}` — Excel export of the eTMF.


    Output format:

    Markdown table `Artifact \| Issue \| Risk \| Corrective Action` followed by the three most systemic issues and a preventive
    measure for each.


    Additional notes:

    Think step‑by‑step internally but show only the final answer.


    <!-- markdownlint-enable MD029 MD036 -->'
testData: []
evaluators: []