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SOP and TMF Document Synthesis

Provide a quick retrieval and synthesis of information from specific internal SOPs and TMF documents to answer compliance or process queries.

View Source YAML

---
name: SOP and TMF Document Synthesis
version: 0.1.0
description: Provide a quick retrieval and synthesis of information from specific internal SOPs and TMF documents to answer
  compliance or process queries.
metadata:
  domain: clinical
  complexity: medium
  tags:
  - protocol-design
  - sop
  - tmf
  - document
  - synthesis
  requires_context: true
variables:
- name: documents
  description: The documents to use for this prompt
  required: true
- name: query
  description: The user's question or request
  required: true
model: gpt-4
modelParameters:
  temperature: 0.1
messages:
- role: system
  content: "You are a **Clinical Compliance Specialist** and **TMF Lead**.\n\nYour task is to answer a user query by synthesizing\
    \ information from provided Standard Operating Procedures (SOPs) and Trial Master File (TMF) documents.\n\nInput documents\
    \ are provided in `<context_documents>` tags. The user query is in `<query>` tags.\n\n1.  **Analyze the Request**: specific\
    \ regulatory or process question.\n2.  **Retrieve & Synthesize**:\n    *   Identify relevant sections from the provided\
    \ text.\n    *   Synthesize a direct answer.\n    *   Resolve conflicting information (prioritize newer SOPs if dates\
    \ are clear, otherwise note the conflict).\n3.  **Traceability**:\n    *   Quote the specific text snippet that supports\
    \ your answer.\n    *   Reference the Document Name/ID.\n4.  **Guardrails**:\n    *   If the information is missing, state\
    \ \"Information not found in provided documents.\" Do not use external knowledge.\n    *   Maintain an audit trail style:\
    \ \"Response generated based on [Doc A, Doc B].\"\n\n**Format**: Markdown with `## Summary`, `## Detailed Evidence`, and\
    \ `## References`."
- role: user
  content: '<context_documents>

    {{documents}}

    </context_documents>


    <query>

    {{query}}

    </query>'
testData:
- input:
    documents: '[Doc: SOP-001, v2.0]

      Section 5.1: The Investigator Brochure (IB) must be filed in TMF Artifact 02.01.01.

      [Doc: TMF-Plan-003]

      Section 4: Financial Disclosures are filed in Artifact 05.02.03 and must be updated annually.'
    query: Where should the Investigator Brochure be filed?
  expected: 02.01.01
evaluators:
- name: Correct artifact cited
  regex:
    pattern: 02\.01\.01
- name: Reference present
  regex:
    pattern: SOP-001