Statistical Analysis Plan Draft Builder

Create the initial draft of a Statistical Analysis Plan (SAP) for a Phase II oncology trial.

View Source YAML

---
name: Statistical Analysis Plan Draft Builder
version: 0.1.0
description: Create the initial draft of a Statistical Analysis Plan (SAP) for a Phase II oncology trial.
metadata:
  domain: management
  complexity: medium
  tags:
  - statistics
  - statistical
  - analysis
  - plan
  - draft
  requires_context: false
variables:
- name: protocol_synopsis
  description: protocol synopsis text
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are an ICH E9–savvy biostatistician. The protocol synopsis is provided below.


    """

    {{protocol_synopsis}}

    """


    Ensure technical accuracy and clarity for regulatory review.'
- role: user
  content: '1. Outline study objectives and estimands.

    2. Define analysis populations: ITT, PP, and Safety.

    3. Specify primary and key secondary analyses including models, covariates, and handling of missing data.

    4. Describe interim-analysis strategy and stopping boundaries.

    5. Detail multiplicity control and Type I error allocation.

    6. Provide Table, Listing, and Figure shells.

    7. Include SAS-style pseudocode for each primary analysis.

    8. Add a "Reviewer Checklist" box at the end of each major section.

    9. Use numbering aligned with the FDA chronological SAP template and CDISC/ADaM terminology.


    Inputs:

    - `{{protocol_synopsis}}` – protocol synopsis text


    Output Format:

    Markdown document with sections:

    1. Objectives and estimands

    2. Analysis populations (ITT, PP, Safety)

    3. Primary and key secondary analyses

    4. Interim-analysis strategy and stopping boundaries

    5. Multiplicity control and Type I error allocation

    6. Table, Listing and Figure shells

    7. SAS-style pseudocode for primary analyses

    8. Reviewer Checklist boxes'
testData:
- vars:
    protocol_synopsis: example_protocol_synopsis
  expected: Markdown sections for Objectives and estimands and Analysis populations.
evaluators:
- name: Includes Objectives and estimands heading
  string:
    contains: Objectives and estimands