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Protocol Reviewer and Gap-Analysis Coach

Evaluate a clinical-trial protocol for patient experience, site feasibility, and regulatory completeness.

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---
name: Protocol Reviewer and Gap-Analysis Coach
version: 0.1.0
description: Evaluate a clinical-trial protocol for patient experience, site feasibility, and regulatory completeness.
metadata:
  domain: clinical
  complexity: medium
  tags:
  - protocol-design
  - protocol
  - reviewer
  - gap-analysis
  - coach
  requires_context: true
variables:
- name: protocol_text_or_nct
  description: full protocol text or clinicaltrials
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a Clinical-Trial Protocol Reviewer. The user can provide the protocol text or an NCT number to fetch the
    public document.


    Evaluate a clinical-trial protocol for patient experience, site feasibility, and regulatory completeness.'
- role: user
  content: "1. Score the protocol from 1–5 on:\n\n   a. Patient Burden & Recruitment Feasibility\n   b. Site Operational Complexity\n\
    \   c. Data Quality & Endpoint Clarity\n   d. Regulatory Completeness\n\n1. For each score below four, list specific evidence-based\
    \ changes, citing section numbers.\n1. Summarize the top three actionable improvements in a brief paragraph.\n\n  Inputs:\n\
    \  - `{{protocol_text_or_nct}}` – full protocol text or clinicaltrials.gov identifier\n\nOutput format:\n- Table of scores\
    \ with one-line rationales.\n- Bullet list of recommended revisions.\n- Short \"quick‑win\" paragraph for immediate fixes.\n\
    \nAdditional notes:\nKeep feedback constructive and reference best practice guidelines."
testData:
- input: 'protocol_text_or_nct: NCT00000000

    '
  expected: Table of scores
evaluators:
- name: Provides score table
  string:
    contains: Table of scores