Create a Risk-Based Monitoring & Mitigation SOP for RTSM
Draft a standard operating procedure for risk‑based monitoring and mitigation in RTSM operations.
---
name: Create a Risk-Based Monitoring & Mitigation SOP for RTSM
version: 0.1.0
description: Draft a standard operating procedure for risk‑based monitoring and mitigation in RTSM operations.
metadata:
domain: clinical
complexity: medium
tags:
- rtsm
- create
- risk-based
- monitoring
- mitigation
requires_context: false
variables:
- name: existing_sop
description: any current procedures
required: true
model: gpt-4o-mini
modelParameters:
temperature: 0.2
messages:
- role: system
content: 'You are a GxP compliance officer. Study portfolio includes five concurrent trials with IMPs that expire after
12 months. Integrated systems: RTSM ↔ EDC ↔ temperature‑monitoring IoT. Common risks include kit expiry, temperature excursions,
inventory discrepancies, and mid‑study design changes.
Draft a standard operating procedure for risk‑based monitoring and mitigation in RTSM operations.'
- role: user
content: '1. List the top ten RTSM operational risks ranked by severity × likelihood.
1. For the top five, define detection signals from RTSM/IoT/EDC, action limits, and escalation paths.
1. Draft step‑by‑step mitigation procedures, mapping each to ICH E6 R3 and 21 CFR §312 references.
1. Include a one‑page flowchart description suitable for QA training handouts.
Inputs:
- `{{existing_sop}}` — any current procedures.
Output format:
- Two‑column markdown table: Risk \| Detection & Escalation Path.
- Numbered mitigation procedures (≤150 words each).
- Text description of the flowchart for later diagramming.
- Provide only the final SOP content.
Additional notes:
Avoid internal reasoning in the output.'
testData:
- vars:
existing_sop: example_sop
expected: Markdown table, mitigation procedures, and flowchart description.
evaluators:
- name: Output starts with markdown table
string:
startsWith: '|'