Clifford Chance

In the first, of what may become a series of short articles looking at the major challenges of the digitalization of the European healthcare market, this article focuss on the special requirements for the data collection, processing and retention in clinical studies on medicinal products.

Clinical trials are governed by Regulation (EU) No 536/2014 of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC (Clinical Trials Regulation). It seeks to create a streamlined administrative system and approval process for multi-centre clinical trials in Europe. The Clinical Trials Regulation also provides access to a single portal for clinical trial applications, making it easier to conduct complex, multi-site trials in several EU member states with one single application. It is anticipated to make Europe more attractive as a forum to conduct clinical trials. 

Clinical trial data collection and processing

According to the Clinical Trials Regulation, a clinical trial may be conducted only if, inter alia, the rights of the affected subjects to privacy and the protection of their personal and health data are safeguarded. All clinical trial information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal and health data of the subjects remain protected in accordance with the applicable law on personal data protection. Moreover, appropriate technical and organisational measures shall be implemented to protect information and personal data against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss. 

In any case, a clinical trial may only be conducted if the subjects, or where a subject is not able to give informed consent, his or her legally designated representative, have given informed consent, after having been duly informed about all relevant aspects of the trial, including, but not limited to:

• its nature, objectives, benefits, implications, risks and inconveniences; 
• the subject's rights and guarantees regarding his or her protection, in particular, his or her right to refuse to participate and the right to withdraw from the clinical trial at any time without any resulting detriment and without having to provide any justification; 
• the conditions under which the clinical trial is to be conducted, including the expected duration of the subject's participation in the clinical trial; and 
• the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical trial is discontinued. 

Data retention 

Without prejudice to applicable law on data protection, the sponsor of the clinical trial may ask the subject or, where the subject is not able to give informed consent, his or her legally designated representative at the time when the subject or the legally designated representative gives his or her informed consent to participate in the clinical trial to consent to the use of his or her data outside the protocol of the clinical trial exclusively for scientific purposes. This consent may be withdrawn at any time by the subject or his or her legally designated representative. The scientific research making use of the data outside the protocol of the clinical trial shall be conducted in accordance with the applicable law on data protection. Also, any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the clinical trial at any time by revoking his or her informed consent. 

However, without prejudice to applicable law on data protection, the withdrawal of the informed consent shall not affect the activities already carried out and the use of personal and health data obtained based on informed consent before its withdrawal. 

Read Gunnar's detailed sector-specific contributions on this subject at dataguidance.com.