EU: Commission outlines how EU data protection rules affect clinical trial sponsors

19-04-2019

EU: Commission outlines how EU data protection rules affect clinical trial sponsors

(Source: RAPS 2019-04-19)

The European Commission has published a document detailing the interplay between clinical trial rules and the General Data Protection Regulation (GDPR). The document sets out the data protection requirements of the incoming Clinical Trials Regulation (CTR) and how they interact with GDPR.

CTR places stronger requirements on sponsors to record, process, store and handle data in ways that enable accurate reporting and interpretation, without threatening the confidentiality of the records.

However, the data are also subject to the trans-industry requirements imposed by GDPR. As such, the Commission thinks the onus is on sponsors to “implement the appropriate technical and organizational measures to ensure and be able to demonstrate that the personal data are processed in accordance with the data protection rules.”

Exactly how CTR and GDPR apply depends on whether data is being processed purely for research or if the activity has a health protection objective. The question and answer document created by the Commission sets out the regulations that apply in each situation and their implications for sponsors.

Other parts of the document deal with specific situations that can arise during clinical development, such as the implications of a subject withdrawing their consent for participation in a study. In that situation, the investigator should talk to the trial subject to determine whether they are withdrawing their consent to participate in trial activities or if they are also barring the processing of their data.

More Information On RAPS

New Article