The European Commission have released a document which outlines the interplay between the clinical trial rules and the General Data Protection Regulation (GDPR). The guidance describes the data protection requirements of the new incoming Clinical Trials Regulation (CTR) and how the regulation relates to GDPR. The question and answer (Q&A) document will only be relevant when the CTR is implemented, however question 11 details the current situation under the Clinical Trials Directive.
The CTR places stronger requirements on clinical trial sponsors to record, process, store and handle data with methods that enable accurate reporting and interpretation, without threatening the confidentiality of the records. Data is also subject to the trans-industry requirements that are imposed by GDPR. Therefore, the European Commission has stated that sponsors are responsible for implementing the “appropriate technical and organisational measures to ensure and be able to demonstrate that the personal data are processed in accordance with the data protection rules.”
The application of CTR and GDPR depends on whether data is processed solely for research or if the activity has a health protection objective. In the Q&A document, the European Commission have outlined the regulations that apply for each situation and the implications they have for sponsors.
The Q&A document also covers specific situations that may arise during clinical development, for example the implications of a subject withdrawing their consent for participation in a study. In this scenario, the Commission recommends that the investigator should have a discussion with the trial subject to determine if they are withdrawing their consent to participate in trial activities or whether they are also barring processing of their data.
To read the European Commission Q&A document on the interplay between the CTR and the GDPR, please click here.