EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)

On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial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.

The Regulation aims to foster innovation through simplification of the clinical trial application process and to increase transparency and availability of information on clinical trials and their results.

The agency, in collaboration with the Member States and the European Commission (EC), has the obligation to set up and maintain a EU Portal as a single entry point for the submission of data and documents relating to clinical trials and a EU Database containing the data and documents submitted via the EU Portal in accordance with the Regulation.

The EU Database should contain all relevant information as regards the clinical trials submitted through the EU Portal. To ensure transparency of clinical trials, the EU Database should be publicly accessible and data should be presented in an easily searchable format.

This guidance document focuses on the following areas:

• Description of the CTIS structure and components including a description of the functionalities and publication rules for clinical trials information submitted to the CTIS (chapter 2)

• The protection of personal data as part of the clinical trial information submitted to CTIS (chapter 3)

• The protection of commercially confidential information (CCI) as part of the clinical trial information submitted to CTIS (chapter 4)

• The protection of personal data and CCI in inspection reports (chapter 5)

The CTR sets out requirements for the protection of personal data, CCI and increased transparency of 1clinical trials in the EU. These requirements apply to information contained in the EU Database.

Click this LINK to know more detailed information on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System.