Taking A Proactive, Preventive Approach To Data Privacy In Clinical Documentation

By Simin Takidar, Senior Principal Medical Writer; and Bipasha Das, Head of the Parexel Clinical Trial Disclosure Group

Data privacy has become critical as citizens demand control over their data, supported by global regulations. The EU Clinical Trials Regulation (EU-CTR 536/2014) and GDPR mandate transparency and patient privacy in clinical trials, posing challenges for documentation, especially in rare diseases. Compliance requires understanding the role of data controllers, robust redaction, and anonymization processes.

Common pitfalls include inadequate technical measures, insufficient insight, and over-reliance on manual or automated redaction methods. Parexel Regulatory Consulting Services offers an end-to-end solution with AI-driven tools for identifying sensitive data, combined with regulatory expertise to ensure compliance and efficiency. Their approach includes proactive privacy measures and detailed regulatory guidance to support smooth and timely submissions.