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:
- 2. Documentation and Change Control:
- 3. Data Integrity and Data Security:
At the exciting prospect of health records and EDC systems coming together, this is an approach that could ensure that data integrity is fulfilled.