EU CTR Countdown – Don’t forget about Personal Data Protection

Posted in Process Improvement

There are less than 3 months until the next phase of the EU CTR transition period.

From 31Jan2023, sponsors will be required to use CTIS for new clinical trial applications for studies in the European Union (EU) / European Economic Area (EEA) and from 31Jan2025, any clinical trials approved under the Clinical Trials Directive (CTD) that are ongoing will need to comply with the Clinical Trials Regulation (CTR) and be recorded in CTIS.

A reminder of the significant changes from CTD to CTR:

  • A streamlined application procedure via a single-entry point via CTIS
  • A single authorization procedure for all clinical trials
  • A harmonized procedure for the assessment of applications for clinical trials
  • Strictly defined deadlines for the assessment of clinical trial applications
  • Simplified reporting procedures
  • Strengthened transparency for clinical trials data

With this deadline looming, there is likely a scramble to ensure that all the appropriate processes are in place to ensure compliance but let’s not lose sight of the potential privacy risks associated with implementation of CTIS. Article 81(4) of the Regulation states that the “EU Database shall be publicly accessible… protecting personal data…” and Recital 67 further notes that “no personal data of data subjects participating in a clinical trial should be recorded in the EU Database.” During the trial life cycle there are a number of documents that may be required to be uploaded to CTIS that may need to be anonymized to protect participants’ personal information including safety related documents and serious breach documentation. DRAFT Guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS) provides detailed guidance on the management of personal data in documented submitted to CTIS.

Detailed information, including information on CTIS and to view the Regulation (EU) No 536/2014, can be found at Clinical Trials Regulation. Additionally, in September 2022, Clinical Trials Regulation (EU) No 536/2014 Questions and Answers Version 6.2 was updated to version 6.2.

WCG Avoca Quality Consortium (AQC) resources are currently being reviewed and revised to ensure alignment with EU CTR. AQC Members can keep an eye on the Regulatory Bibliography for updates.

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Karen Harvey

Senior Director, Avoca Quality Consortium

WCG Avoca