Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of Personal Data and Commercially Confidential Information while using the Clinical Trials Information System (CTIS) version 1.0".
The purpose of this guidance document is to assist CTIS users in navigating through CTIS functionalities as well as understanding the major principles for ensuring personal data and commercially confidential information are protected when using CTIS and publishing clinical trial information and documents.
EU Clinical Trials Information System (CTIS) is an IT platform, that includes the EU portal and EU database, that allows the exchange of clinical trials information in the European Union.
Personal Data (PD) means any information relating to an identified or identifiable natural person (‘data subject’).
Commercially Confidential Information (CCI) is defined as any information submitted to CTIS which is not in the public domain, or publicly available, and where disclosure may undermine the legitimate economic interest or competitive position of the owner of the information.
In order to promote innovation, the Clinical Trials Regulation harmonises the content of clinical trial applications which in turn increases the transparency and availability of information about clinical trials. The EU Database should be publicly accessible and data should be presented in an easily searchable format to ensure transparency of clinical trials.
EU clinical trial database provides the public information on clinical trial applications, and clinical trials conducted between the time of decision and the submission of summary results.
In this guidance the chapter, "Rules for submitting and publishing clinical trial information in CTIS", clinical trial information, including data and documents, is discussed and how the information should be managed so that personal data and commercially confidential information (CCI) can be protected while meeting publication principles.
To know more about "Management of personal data in structured data fields and in documents submitted to CTIS" click this LINK and to identify the "Data and documents uploaded by the trial sponsor and Marketing Authorisation Applicants/Holders that provide Clinical Study Reports (CSRs)"click this annexure LINK.