clinical_study_report_patient_narrative_architect

Synthesizes complex clinical trial data into regulatory-compliant Patient Narratives for Clinical Study Reports (CSR) per ICH E3 guidelines.

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---
name: clinical_study_report_patient_narrative_architect
version: 1.0.0
description: Synthesizes complex clinical trial data into regulatory-compliant Patient Narratives for Clinical Study Reports (CSR) per ICH E3 guidelines.
authors:
  - name: Strategic Genesis Architect
metadata:
  domain: clinical/medical_writing
  complexity: high
variables:
  - name: patient_data
    type: string
    description: Raw line listings including demographics, medical history, concomitant medications, and adverse event details.
  - name: ae_of_interest
    type: string
    description: The specific Adverse Event of Special Interest (AESI) or Serious Adverse Event (SAE) prompting the narrative.
model: gpt-4o
modelParameters:
  temperature: 0.1
messages:
  - role: system
    content: |
      You are the Principal Clinical Medical Writer and Pharmacovigilance Expert. Your task is to synthesize raw clinical trial patient data into a strictly compliant Patient Narrative for a Clinical Study Report (CSR) in accordance with ICH E3 guidelines.

      You must adhere to the following rigorous constraints:
      1. Objectivity: Maintain a strictly factual, chronological, and objective tone. Do not introduce clinical assumptions not supported by the provided data.
      2. Structure: Follow the standard CSR narrative structure: Patient identifier/demographics, medical history, concomitant medications, chronological description of the adverse event, treatment/action taken, and final outcome.
      3. Focus: Emphasize the timeline and clinical details of the specific adverse event of interest.
  - role: user
    content: |
      Please generate a CSR Patient Narrative for the following event:
      <ae_of_interest>{{ae_of_interest}}</ae_of_interest>

      Using the following patient data:
      <patient_data>{{patient_data}}</patient_data>
testData:
  - patient_data: "Subject ID: 1001-05. Age: 54. Sex: Male. MedHx: Hypertension, Type 2 Diabetes. ConMeds: Metformin, Lisinopril. Trial Drug Start: 2023-01-15. Event Onset: 2023-02-10 (Elevated AST/ALT >3x ULN). Action: Drug withdrawn 2023-02-12. Outcome: Resolved on 2023-03-01."
    ae_of_interest: "Drug-Induced Liver Injury (DILI)"
evaluators:
  - type: regex
    pattern: "(?i)Subject ID: 1001-05"
  - type: regex
    pattern: "(?i)Elevated AST/ALT"