Publications de Thomas ROCHE

Cross-border flows of biological samples used in a clinical trial do not require authorisation from the French Ministry of Research.

International multi-centre clinical trials very often require cross-border flows of biological samples. These flows are intended to transfer the samples to the central laboratories, which may not necessarily be in the same country as the investigating centres that collected the biological samples. In order to carry out such flows in the...

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Les flux transfrontaliers d’échantillons biologiques intervenant dans un essai clinique ne nécessitent pas d’autorisations du ministère de la Recherche

Les essais cliniques multicentriques internationaux nécessitent très souvent des flux transfrontaliers d’échantillons biologiques. Ces flux sont destinés à transférer les échantillons à des laboratoires centraux ne se trouvant pas forcément dans le même pays que les centres investigateurs qui sont à l’origine du recueil de ces échantillons biologiques....

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The contact details of the sponsor’s DPO do not have to appear on the ICFs !

The GDPR is often used in an inappropriate way and unfortunately in a less than pragmatic fashion. The legal system is not a binary system, it is far more complex than that. What should be done where two legal frameworks apply to a single situation and these legal frameworks seem to contradict each other ? For instance, how should we react if...

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The Sponsor is the sole data controller in the context of clinical studies

As part of our external DPO assignments, we often encounter difficulties during the elaboration or evaluation of Privacy Impact Assessments carried out to determine the compliance of personal data processing operations in the context of multicentric clinical trials conducted throughout the European Union. Indeed, we are frequently asked to...

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