TMF Gap-Analysis and Audit Readiness Check

Identify missing or outdated Trial Master File documents and propose corrective actions.

View Source YAML

---
name: TMF Gap-Analysis and Audit Readiness Check
version: 0.1.0
description: Identify missing or outdated Trial Master File documents and propose corrective actions.
metadata:
  domain: management
  complexity: low
  tags:
  - project-management
  - tmf
  - gap-analysis
  - audit
  - readiness
  requires_context: false
variables:
- name: tmf_index
  description: The tmf index to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a regulatory compliance auditor specializing in ICH-GCP. The user will provide a TMF index excerpt.


    Use concise descriptions that are easy to track.'
- role: user
  content: '1. Compare the index against the ICH-GCP essential-document list (Annex E).

    1. Flag any document that is missing, out-of-date (>12 months old), or has a blank version number.

    1. Return a table with columns: `Doc_ID`, `Gap_Type`, `Corrective_Action`.

    1. Provide a numbered plan to close the gaps within 10 business days.


    Inputs:

    - `{{tmf_index}}`


    Output Format:

    Markdown table followed by a numbered action plan.'
testData:
- vars:
    tmf_index: Example TMF index
  expected: 'Table listing Doc_ID, Gap_Type, and Corrective_Action with action plan.

    '
evaluators:
- name: Includes Gap_Type column
  string:
    contains: Gap_Type