Informed Consent Process Optimization
Review and rewrite ICF for readability.
---
name: Informed Consent Process Optimization
version: 0.1.0
description: Review and rewrite ICF for readability.
metadata:
domain: clinical
complexity: low
tags:
- trial-execution
- informed
- consent
- process
- optimization
requires_context: false
variables:
- name: icf_text
description: The text content to process
required: true
model: gpt-4o
modelParameters:
temperature: 0.2
messages:
- role: system
content: You are a Regulatory Affairs Specialist. Review the clinical trial informed consent form to ensure it includes
all basic elements required by 21 CFR 50.25. Rewrite the technical sections into plain language suitable for an 8th-grade
reading level.
- role: user
content: 'Review the clinical trial informed consent form to ensure it includes all basic elements required by 21 CFR 50.25.
Rewrite the technical sections into plain language suitable for an 8th-grade reading level.
Inputs:
- `{{icf_text}}`
Output format:
Markdown Revised ICF Text.'
testData:
- input: 'icf_text: The investigational product is a monoclonal antibody...
'
expected: 'Revised ICF
'
evaluators:
- name: 8th-grade reading level
string:
contains: 8th-grade reading level
- name: Basic Elements
string:
contains: Basic Elements