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IRB Protocol Review

Evaluate a clinical investigation protocol to ensure it meets IRB approval criteria.

View Source YAML

---
name: IRB Protocol Review
version: 0.1.0
description: Evaluate a clinical investigation protocol to ensure it meets IRB approval criteria.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - compliance
  - irb
  - protocol
  - review
  requires_context: false
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.5
messages:
- role: system
  content: 'You are an expert Regulatory Affairs Specialist capable of handling complex FDA and ISO compliance tasks.


    ## Context

    21 CFR Part 56


    ## Objective

    Evaluate a clinical investigation protocol to ensure it meets IRB approval criteria.


    ## Output Format

    Checklist of compliance items.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Clinical protocol and informed consent forms. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Verify