CSR Results and Safety Section

Draft Sections 11 and 12 of an ICH E3 clinical study report.

View Source YAML

---
name: CSR Results and Safety Section
version: 0.1.0
description: Draft Sections 11 and 12 of an ICH E3 clinical study report.
metadata:
  domain: technical
  complexity: medium
  tags:
  - technical-writing
  - csr
  - results
  - safety
  - section
  requires_context: false
variables: []
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior regulatory medical writer preparing the final CSR for a completed Phase II trial of **Drug X**
    in moderate plaque psoriasis. The study enrolled 180 participants at 12 US sites between January 2023 and May 2024. Primary
    endpoint PASI‑75 at Week 16 showed 74 % vs 48 % for placebo (p = 0.032). Two SAEs were unrelated to the drug (appendicitis
    and a fracture). Appendix A contains full statistical tables and figures.


    Ensure scientific style and note dependencies on Appendix A.'
- role: user
  content: '1. Follow ICH E3 headings and numbering.

    2. Write concisely in past tense, third person (≤ 2 500 words).

    3. Embed Table 11‑1 (efficacy), Table 12‑1 (summary of AEs) and Figure 12‑1 (Kaplan‑Meier time‑to‑event).

    4. Cite data sources inline.

    5. List any missing information required to finalize the section.

    6. If information is insufficient, ask up to three clarifying questions before drafting.


    Inputs:

    - None


    Output Format:

    1. **Efficacy Evaluation** section including Table 11‑1

    2. **Safety Evaluation** section including Table 12‑1 and Figure 12‑1

    3. Bullet list of missing information, if any'
testData:
- vars: {}
  expected: 'Efficacy Evaluation

    Safety Evaluation'
evaluators:
- name: Includes Efficacy Evaluation heading
  string:
    contains: Efficacy Evaluation
- name: Includes Safety Evaluation heading
  string:
    contains: Safety Evaluation