Audit Trail Review
Review subject audit logs for compliance and data integrity.
---
name: Audit Trail Review
version: 0.1.0
description: Review subject audit logs for compliance and data integrity.
metadata:
domain: clinical
complexity: medium
tags:
- data-management
- audit
- trail
- review
requires_context: true
variables:
- name: audit_logs
description: 'System Specifications (Audit reqs): `{{system_specs}}`'
required: true
- name: system_specs
description: The system specs to use for this prompt
required: true
model: gpt-4o
modelParameters:
temperature: 0.2
messages:
- role: system
content: You are a Clinical Data Auditor. Review subject audit logs to provide documentary evidence of the sequence of activities
completed and verify compliance with signature requirements. Adhere to 21 CFR Part 11 and GCP.
- role: user
content: 'Examine the provided electronic audit trail and generate a summary report identifying who modified data, when,
and why, while verifying that the trail captures required signature details.
Inputs:
- Electronic Audit Logs (snippet): `{{audit_logs}}`
- System Specifications (Audit reqs): `{{system_specs}}`
Output format:
Markdown Audit Review Report.'
testData:
- input: 'audit_logs: "2023-01-01 10:00:00 UserA Modified Dose from 10 to 20. Reason: Typo."
system_specs: "Must capture Reason for Change."
'
expected: 'Audit Review Report
'
evaluators:
- name: User Identification
string:
contains: UserA
- name: Modification Details
string:
contains: Dose