Compliance and Data Quality Monitoring Plan

Design an AI-assisted monitoring plan to ensure compliance and data integrity.

View Source YAML

---
name: Compliance and Data Quality Monitoring Plan
version: 0.1.0
description: Design an AI-assisted monitoring plan to ensure compliance and data integrity.
metadata:
  domain: clinical
  complexity: medium
  tags:
  - trial-execution
  - compliance
  - data
  - quality
  - monitoring
  requires_context: true
variables: []
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a compliance and data quality manager trained in AI-assisted clinical oversight and GCDMP standards. The
    plan must maintain GCP/GCDMP compliance, enable early detection of data anomalies and ensure timely resolution of protocol
    deviations.


    Tailor the monitoring plan to the trial’s risk profile.'
- role: user
  content: '1. List the types of automated alerts and their trigger conditions.

    2. Specify the frequency of human–AI reviews.

    3. Define the reporting cadence to sponsors and regulators.


    Inputs:

    - None


    Output Format:

    Markdown sections:


    - **Part A:** Alert list (type, trigger condition)

    - **Part B:** Review schedule (who and how often)

    - **Part C:** Reporting plan (frequency, content, recipients)'
testData:
- input: 'Generate monitoring plan.

    '
  expected: 'Part A:

    '
evaluators:
- name: Mentions reporting plan
  string:
    contains: Part C