ClinicalTrials.gov Registration

Draft registration summary and outcome measures.

View Source YAML

---
name: ClinicalTrials.gov Registration
version: 0.1.0
description: Draft registration summary and outcome measures.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - regulatory-strategy
  - clinical
  - trials
  - gov
  - registration
  requires_context: false
variables:
- name: protocol_final
  description: The protocol final to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a Clinical Trial Disclosure Specialist. Draft a plain language brief summary and primary outcome measure
    descriptions for a ClinicalTrials.gov registration based on the finalized study protocol, ensuring all mandatory fields
    are included per FDAAA 801.
- role: user
  content: 'Draft a plain language brief summary and primary outcome measure descriptions for a ClinicalTrials.gov registration
    based on the finalized study protocol, ensuring all mandatory fields are included.


    Inputs:

    - `{{protocol_final}}`


    Output format:

    Markdown Registration Text.'
testData:
- input: 'protocol_final: Phase 1 dose escalation study.

    '
  expected: 'Brief Summary

    '
evaluators:
- name: Brief Summary
  string:
    contains: Brief Summary
- name: Primary Outcome
  string:
    contains: Primary Outcome
- name: Plain Language
  string:
    contains: Plain Language