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Protocol Section Refinement

Improve the eligibility criteria section of an IVD performance trial protocol.

---
name: Protocol Section Refinement
version: 0.1.0
description: Improve the eligibility criteria section of an IVD performance trial protocol.
metadata:
  domain: clinical
  complexity: medium
  tags:
    - clinical
    - protocol
variables:
  - name: condition
    description: disease or study condition
    required: true
  - name: draft_section
    description: current text of the protocol section
    required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.1
testData:
  - inputs:
      condition: Sample condition
      draft_section: Sample draft_section
    expected: Inclusion
evaluators: []
---

## Purpose
You are an experienced clinical operations lead refining a protocol targeting a specific condition.

Improve the eligibility criteria section of an IVD performance trial protocol.

## Instructions
1. Provide specific inclusion and exclusion rules (e.g., sample type, analyte range, comorbidities).
2. Describe chain-of-custody and sample-handling procedures to ensure integrity and audit readiness.
3. Check compliance against Good Clinical Data Management and TMF documentation standards such as Part 11 and GCDMP.

  Inputs:
  - `{{ condition }}` – disease or study condition
  - `{{ draft_section }}` – current text of the protocol section

Output format:
Revised section in Markdown with clear subsections for criteria and handling procedures.

Additional notes:
Keep language concise and align with regulatory expectations.