Regulation (EU) No. 536/2014 paved the way for a central European working platform for clinical trials. With the Clinical Trial Information System (CTIS), the European Medicines Agency (EMA) has laid the foundation for enabling the exchange of information and documents via a central online platform. According to the transitional arrangements, use of the online platform was voluntary until January 31, 2023. Applications could still be submitted within the framework of the national approval processes. As of January 31, 2023, applications for new clinical trials must now be submitt via the CTIS Information System – CTIS.
Public and non-public areas of the CTIS Information System – CTIS
The online platform is divid into a public and a private area . For reasons of transparency towards the public and study participants, information on current or planned clinical trials will be provid in the public area . This area will be accessible to website visitors. Interested parties will be able to search for studies and find out about their current status.
In a non-public area, study-relevant documents such as reports, applications, and protocols are exchang and made available between sponsors, france business fax list regulatory authorities, and ethics committees. All participants are provid with their own workspace.
The processing of personal data in both public and private areas therefore has implications for data protection law. It is therefore necessary to clarify which documents are made available via the CTIS.
Relevant documents
In the future, all application procedures and the relevant documents will be handled via the CTIS. As soon as a clinical trial is approv and conduct, google for specific keywords any notifications and reports will be transferr between the regulatory authorities and the sponsors via the CTIS. The list of documents that will be upload and made available via the platform is correspondingly extensive. A corresponding list can be found in the current EMA draft “ Guidance document on how to approach the protection of personal data and commercially confidential information in documents upload and publish in the Clinical Trial Information System (CTIS) ” . In addition to the inform consent form (ICF), this list also includes the study protocol and various safety reports.
. The requirements for anonymizing or pseudonymizing personal data within the documents are then bas on this. Data subjects whose personal data remains in the documents must be inform in advance about this data processing.
Data protection responsibilities and information according to Art. 13 GDPR
From a data protection perspective, the operation and use of the platform are consider processing operations within the framework of joint controllership . A corresponding request was submitt to the albania business directory European Data Protection Officer responsible for the EMA and respond to. The EMA has provided a contract in accordance with Art. 26 GDPR .
Annex II of the Joint Controller Agreement also contains information pursuant to Art. 13 GDPR for data subjects whose personal data is processed via the CTIS. This information provides an initial basis for the sponsor to record the individual data processing operations via and through the CTIS and to integrate the platform into its work processes in compliance with data protection regulations.
Data protection recommendations for integration in the company
The use of CTIS is relevant to data protection law for those involv, and especially for sponsors. The use of an online platform with a public and private area, on which personal and special personal data are process, carries the inherent risk of unjustified disclosure. Therefore, it is recommend to pay due attention to the initial steps in and with CTIS.