Hello everyone, this is Manon DURAND, health lawyer at Pharmaspecific. We are meeting today once again to talk about the GDPR, the General Data Protection Regulation which is, I remind you, the reference text in terms of personal data protection within the EU. It came into force on May 25, 2018 in the EU member states.
The question of the day is whether clinical study technicians (CSTs) are responsible, at their level, for implementing the obligations related to the GDPR or whether it happens at another level. As a reminder, the clinical study technicians are the personnel who will be in charge of entering the study data that are collected from the patients in order to set up the proper conduct of the study. They are confronted with personal data on a daily basis. However, it is not up to them to implement the obligations related to the GDPR since this happens at the level of the data controller.
I remind you that the controller is the person who determines the purposes and means of the processing. In practice, in clinical research, it is the sponsor. Within the sponsor’s organization, there are different levels that can deal with GDPR compliance.
First of all, if a Data Protection Officer has been appointed – which is not always an obligation – if a Data Protection Officer has been appointed, he or she will be responsible for ensuring compliance with the DPMR, i.e., putting in place all the required tools, processing registers, impact assessment where appropriate, supervision of transfers outside the EU, etc.
If there is no DPO in the sponsor’s organization, it will happen either at the level of the legal department if there is one and if not directly at the management level. It is therefore not up to the clinical study technicians to implement GDPR compliance. On the other hand, they must, like all the personnel involved in the study, be trained in the rules of the GDPR, in its spirit and in the way in which the data must be processed, since they are confronted with this data on a daily basis, they must be able to know what they can or cannot do with the data.
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