The European Commission’s Directorate General for Health and Food Safety has published ‘Questions and Answers’ guidance on the interplay between the EU Clinical Trials Regulation and the GDPR. Although the guidance will fully be relevant only when the EU Clinical Trials Regulation enter into effect (currently anticipated next year), some of the guidance has a bearing on the current state of the law.
The Q&A indicate that processing operations related to a specific clinical trial protocol during its whole lifecycle can be legitimized for the trial’s research purposes under the legal bases of the public interest in clinical research, the legitimate interest of the trial sponsor, or in rare cases – consent of trial participants (provided that consent is freely given, specific, withdrawable, informed and unambiguous). The Q&A go on to explain that processing operations for the purposes of drug safety reporting, disclosures to national drug-regulating authorities and archiving of clinical trial data can be legitimized under the legal basis of compliance with legal obligation to which the trial sponsor is subject.
The Q&A also emphasize that the requirement of informed consent under clinical trial law must not be confused with consent as a legal basis for data processing. The former is an ethical and procedural safeguard for the conduct of trials, while the latter is a restrictive legal basis for data processing.
CLICK HERE to read the EU Commission’s Q&A.