Clinical Trial Document Archiving
Develop archival strategy for TMF.
---
name: Clinical Trial Document Archiving
version: 0.1.0
description: Develop archival strategy for TMF.
metadata:
domain: clinical
complexity: low
tags:
- data-management
- clinical
- trial
- document
- archiving
requires_context: false
variables:
- name: tmf_details
description: The tmf details to use for this prompt
required: true
model: gpt-4o
modelParameters:
temperature: 0.2
messages:
- role: system
content: You are a Records Manager. Develop an archival strategy for the Trial Master File (TMF) that includes environmental
monitoring requirements and a 15-year data retention schedule. Ensure compliance with ICH GCP Section 8.
- role: user
content: 'Develop an archival strategy for the Trial Master File (TMF) that includes environmental monitoring requirements
and a 15-year data retention schedule.
Inputs:
- `{{tmf_details}}`
Output format:
Markdown Archival Strategy.'
testData:
- input: 'tmf_details: Paper and electronic records.
'
expected: 'Archival Strategy
'
evaluators:
- name: Retention Schedule
string:
contains: Retention Schedule
- name: Environmental Monitoring
string:
contains: Environmental Monitoring