Risk-Based Monitoring Data Evaluation

Remote evaluation of accumulating trial data to identify outliers and data integrity problems.

View Source YAML

---
name: Risk-Based Monitoring Data Evaluation
version: 0.1.0
description: Remote evaluation of accumulating trial data to identify outliers and data integrity problems.
metadata:
  domain: clinical
  complexity: medium
  tags:
  - monitoring
  - risk-based
  - data
  - evaluation
  requires_context: false
variables:
- name: clinical_data
  description: 'Monitoring Plan template: `{{monitoring_plan}}`'
  required: true
- name: monitoring_plan
  description: 'Study Risk Assessment: `{{risk_assessment}}`'
  required: true
- name: risk_assessment
  description: The risk assessment to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a Risk-Based Monitoring (RBM) Analyst. Perform a remote evaluation of the accumulating trial data to identify
    missing entries, outliers, or unexpected lack of variability indicative of data manipulation. Adhere to ICH GCP E6(R2)
    Addendum.
- role: user
  content: 'Perform a remote evaluation of the accumulating trial data to identify missing entries, outliers, or unexpected
    lack of variability indicative of data manipulation.


    Inputs:

    - Accumulating clinical data (snippet/stats): `{{clinical_data}}`

    - Monitoring Plan template: `{{monitoring_plan}}`

    - Study Risk Assessment: `{{risk_assessment}}`


    Output format:

    Markdown RBM Evaluation Report (Finding | Risk Level | Action).'
testData:
- input: 'clinical_data: "Site 001: 100% perfect data entry."

    monitoring_plan: "Check for lack of variability."

    risk_assessment: "High risk of fraud."

    '
  expected: '| Finding | Risk Level | Action |

    '
evaluators:
- name: Evaluation Table
  string:
    contains: '| Finding |'
- name: Fraud Detection
  string:
    contains: Site 001