Design a Robust Preclinical Pathology Study Protocol

Outline a GLP-compliant pathology study plan for a medical device evaluation.

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---
name: Design a Robust Preclinical Pathology Study Protocol
version: 0.1.0
description: Outline a GLP-compliant pathology study plan for a medical device evaluation.
metadata:
  domain: scientific
  complexity: medium
  tags:
  - pathology
  - design
  - robust
  - preclinical
  - study
  requires_context: false
variables:
- name: study_details
  description: summary of the device and objectives
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior preclinical pathologist. The study must comply with FDA 21 CFR 58 and ISO 10993-6.


    Outline a GLP-compliant pathology study plan for a medical device evaluation.'
- role: user
  content: "1. Provide risk-based selection of species, sample sizes, and timepoints.\n1. Describe necropsy procedures, macro-\
    \ and histopathology endpoints.\n1. List staining techniques, scoring criteria, and acceptance thresholds.\n1. Explain\
    \ imaging modalities such as micro-CT or SEM.\n1. Include QA steps to maintain GLP compliance.\n1. Organize the output\
    \ under these headings:\n   - Study Overview\n   - In-life Procedures\n   - Pathology Assessments\n   - Imaging\n   -\
    \ Quality Assurance\n1. Use bullet points under each section.\n\nInputs:\n- `{{study_details}}` – summary of the device\
    \ and objectives.\n\nOutput format:\nMarkdown outline using the sections above.\n\nAdditional notes:\nKeep language concise\
    \ and suitable for protocol drafting."
testData: []
evaluators: []