Trial Master File (TMF) Maintenance
Generate TMF checklist based on CDISC Reference Model.
---
name: Trial Master File (TMF) Maintenance
version: 0.1.0
description: Generate TMF checklist based on CDISC Reference Model.
metadata:
domain: clinical
complexity: low
tags:
- data-management
- trial
- master
- file
- tmf
requires_context: true
variables:
- name: study_phase
description: The study phase to use for this prompt
required: true
model: gpt-4o
modelParameters:
temperature: 0.2
messages:
- role: system
content: You are a TMF Specialist. Generate a checklist for the Trial Master File (TMF) based on the CDISC TMF Reference
Model, categorizing documents required before, during, and after the clinical phase to ensure audit readiness.
- role: user
content: 'Generate a checklist for the Trial Master File (TMF) based on the CDISC TMF Reference Model, categorizing documents
required before, during, and after the clinical phase to ensure audit readiness.
Inputs:
- `{{study_phase}}`
Output format:
Markdown TMF Checklist.'
testData:
- input: 'study_phase: Study Start-up.
'
expected: 'TMF Checklist
'
evaluators:
- name: CDISC TMF Reference Model
string:
contains: CDISC TMF Reference Model
- name: Audit Readiness
string:
contains: Audit Readiness