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What impact for clinical trials?

September 10, 2020

The European Data Protection Board (“EDPB”) has recently adopted a public version of the new 07/2020 guidelines on controller and processor concepts for consultation. Those are in substitution of the opinion of Working Party 29 on the above concepts.

The main objective pursued by these guidelines is to avoid any future concerns about the implications and interpretations of these different roles and to define them in a clear and sufficiently understandable way through the European Union (“EU”) and the European Economic Area (“EEA”). It is also appropriate through these guidelines to frame the distinctive obligations subject to processors and the implication of the role of the joint controllers.

What impact for clinical trials?

These guidelines provide insight into the roles defined in clinical trials. In fact, it is possible that the protocol be written jointly by the investigator and the sponsor or only by the sponsor itself. In this situation, “the investigator should be considered as a processor and the sponsor as the controller for this clinical trial”. In such case, the investigator just accepts the protocol already elaborated by the sponsor.

So, what should you do?
A case-by-case analysis is always necessary but you should note that this is a good indication of how to consider the situation when the sponsor is the only one to write the protocol.


Manon Darms
Data Protection Lawyer

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