Risk-Based Monitoring and Quality Plan

Develop a risk-based monitoring plan for a Phase II oncology trial.

View Source YAML

---
name: Risk-Based Monitoring and Quality Plan
version: 0.1.0
description: Develop a risk-based monitoring plan for a Phase II oncology trial.
metadata:
  domain: clinical
  complexity: medium
  tags:
  - trial-execution
  - risk-based
  - monitoring
  - quality
  - plan
  requires_context: false
variables: []
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior GCP compliance advisor. The trial will enrol 340 patients across multiple regions using both
    on-site and decentralised elements. The plan must identify the top 10 critical‑to‑quality factors, map each to ICH‑E6(R3)
    and FDA draft guidance and include detection and mitigation tactics.


    Request any additional information needed before finalising the plan.'
- role: user
  content: '1. Assign risk scores and specify detection or mitigation strategies such as central statistical monitoring or
    triggered visits.

    2. Provide an escalation workflow and communication matrix.

    3. Recommend digital tools and metrics to track risk in real time.


    Inputs:

    - None


    Output Format:

    1. Executive slide outline (bulleted)

    2. Editable risk register in a Markdown table'
testData:
- input: 'Create plan.

    '
  expected: 'risk register

    '
evaluators:
- name: Notes escalation workflow
  string:
    contains: communication matrix