Protocol Optimization and Risk Simulation
Evaluate a draft clinical protocol and simulate the effects of simplifying key elements.
---
name: Protocol Optimization and Risk Simulation
version: 0.1.0
description: Evaluate a draft clinical protocol and simulate the effects of simplifying key elements.
metadata:
domain: clinical
complexity: medium
tags:
- trial-execution
- protocol
- optimization
- risk
- simulation
requires_context: false
variables:
- name: draft_protocol
description: proposed protocol text
required: true
model: gpt-4o
modelParameters:
temperature: 0.2
messages:
- role: system
content: 'You are a clinical operations expert with extensive experience in protocol design and risk management. Review
the protocol to identify operational bottlenecks such as site activation delays, complex eligibility requirements or data
collection challenges. Then simulate outcomes under two scenarios: reducing eligibility criteria by 20 % and consolidating
data collection points by 30 %.
Use data‑driven assumptions when estimating impact.'
- role: user
content: '1. Summarize the main operational bottlenecks.
2. For Scenario 1, estimate the impact on timeline, enrollment rate and budget.
3. For Scenario 2, estimate the same metrics.
4. Provide recommendations with quantified justification for each change.
Inputs:
- `{{draft_protocol}}` – proposed protocol text
Output Format:
Markdown sections:
- **Section A:** Bottlenecks
- **Section B:** Scenario 1 – metrics and narrative
- **Section C:** Scenario 2 – metrics and narrative
- **Section D:** Recommendations'
testData:
- input: 'Draft includes 12 visits and 50 inclusion criteria.
'
expected: 'Section A:
'
evaluators:
- name: Includes recommendations section
string:
contains: 'Section D:'