Goal : to ensure compliant processing regarding to regulatory requirements and more specifically with the reference methodologies (MR).
The controller conducts a PIA. This PIA must be completed before the processing operation is implemented and therefore before the research begins.
The PIA allows to assess and document the compliance of a planned processing operation regarding to applicable regulations requirements (GDPR, Law No. 78-17 of January 6, 1978, on Information Technologies, Data Files and Individual Liberties and Referene Methodoligies) and includes :
On receipt of the elements presenting the research project (protocol/synopsis, list of institutions, etc.) :
Drafting a fixed-price proposal for intervention: a single fare for review of research documents and drafting the PIA.
Proposed schedule to perform PIA.
Mise en place d’une étude de suivi clinique après commercialisation d’un dispositif médical
10 centres : 4 hôpitaux publics + 6 cliniques
Coût par signature signée ou exécuté: 350 €