19/20 March 2024
To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation (CTR), the EMA is preparing a dedicated guidance on the protection of personal data in the Clinical Trials Information System (CTIS). The agency has published a public consultation document to allow for wider stakeholder input. A stakeholder workshop will be held during the public consultation period and further details will be shared when available. The consultation period is open until September 8, 2022
The draft guidance provides detailed information and definitions regarding various clinical trial data and data protection. In accordance with the CTR, the EMA, in collaboration with the Member States and the European Commission (EC), has the obligation to set up and maintain an EU Portal as a single entry point for the submission of data and documents and an EU Database containing the data and documents submitted via the EU Portal. The EU Clinical Trials Portal and Database are jointly referred to as the EU Portal and Database (EUPD).
The EUPD is one of the two components of the Clinical Trial Information System (CTIS). More specifically, the CTIS contains a:
Regarding the management of personal data in documents submitted to the CTIS the draft guideline outlines the general principles on anonymization and pseudonymization of personal data (e.g. personal data of trial participants).
The CTIS contains a dedicated module to be used by GCP inspectors for providing information related to GCP inspections conducted under the CTR. In the inspection module of the CTIS, the inspectors complete a list of structured data and upload an inspection report. GCP inspections can take place at various different sites including, clinical investigator sites, sponsor offices, laboratories, and any facility that has been part of the trial. When preparing an inspection report it is important for the GCP inspectors to know that no personal data of sponsor and clinical site staff (except names of principal investigators), interviewed (study) personnel and inspectors writing the report or attending the inspections, should be available in the version of the inspection report ‘for publication’.
For more information please see the draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial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) published on EMA´s Clinical Trials Information System: training and support Website.