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Loganathan K, Compliance Consultant   |     |  Compliance

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Integrating Electronic Health Record (EHR) systems with Electronic Data Capture (EDC) systems in clinical trials can save time, effort and cost. However, ensuring data integrity and security during such an integration can be tricky.Here is a simple explainer, breaking down the guideline, “Use of Electronic Health Record Data in Clinical Investigations”. There are three key requirements to ensure data integrity and data security in line with the FDA guideline:

    1. Validation and Part 11:

  • Have a validation package for the EDC system and the EHR-EDC integration ready, and make sure it is in accordance with 21 CFR Part 11
  • Assess the EDC system thoroughly and set in place a clear process for compliance
    • 2. Documentation and Change Control:

  • Have appropriate procedures and design documentation in place. This must cover all the requirements for the integration
  • If you have multiple integrations for various EHR systems, make sure you appropriately define, validate and document the cross integrations
  • Set in place a suitable change control process. Make sure that this outlines any updates to the integration and EDC system
  • Ensure that any updates made to the EDC system do not impact the integrity of the EHR data
    • 3. Data Integrity and Data Security:

  • Make sure you comply with HIPAA requirements to ensure data integrity and data security
  • Conduct periodic checks to review the integration logs for any errors to identify and address potential data security gaps
  • At the exciting prospect of health records and EDC systems coming together, this is an approach that could ensure that data integrity is fulfilled.