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ALCOA-C Data Integrity Checklist

Ensure data integrity following ALCOA-C principles.

View Source YAML

---
name: ALCOA-C Data Integrity Checklist
version: 0.1.0
description: Ensure data integrity following ALCOA-C principles.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - regulatory-adherence
  - alcoa-c
  - data
  - integrity
  - checklist
  requires_context: false
variables:
- name: site_role
  description: The role or persona to adopt
  required: true
- name: system_type
  description: The system type to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.1
messages:
- role: system
  content: 'You are a Clinical Quality Assurance (CQA) Auditor. Your task is to create a checklist for clinical site staff
    to ensure all electronic source data entries adhere to the ALCOA-C principles:

    *   **A**ttributable (Who entered it and when?)

    *   **L**egible (Can it be read?)

    *   **C**ontemporaneous (Was it recorded at the time?)

    *   **O**riginal (Is it the first record?)

    *   **A**ccurate (Is it correct?)

    *   **C**omplete (Is all data present?)


    Include specific instructions for the following using Markdown headers:

    1.  **## Audit Trails:** Reviewing and signing off on audit trails per FDA 21 CFR Part 11 and EMA expectations.

    2.  **## User Access:** Ensuring unique user IDs and role-based access controls.

    3.  **## Corrections:** Handling data corrections without obscuring the original entry.


    Format as a Standard Operating Procedure (SOP) checklist.

    '
- role: user
  content: '<system_type>

    {{system_type}} (e.g., eSource, EMR, eCRF)

    </system_type>


    <site_role>

    {{site_role}} (e.g., Study Coordinator, Investigator)

    </site_role>


    Generate the ALCOA-C checklist.

    '
testData:
- input: 'system_type: Direct Data Capture (DDC) Tablet

    site_role: Clinical Research Coordinator (CRC)

    '
  expected: Checklist for CRC ensuring tablet entries are time-stamped, user-specific, and synced daily.
evaluators:
- name: ALCOA Check
  regex:
    pattern: (?i)(Attributable|Legible|Contemporaneous|Original|Accurate)
- name: Audit Trail Check
  regex:
    pattern: (?i)(audit trail|21 CFR)