Europe – Le Code de conduite RGPD des essais cliniques rédigé par l’EUCROF a été soumis le 17 mars à la CNIL

The European CRO Federation (EUCROF), announces the submission for approval by the Data Protection Authorities of the 27 EU Member States and the European Data Protection Board, of its GDPR Code of Conduct for Service Providers in Clinical Research. CNIL* , the French Data Protection Authority as the competent supervisory authority.

Article 40 of Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, also known as “GDPR”, “[…] encourages drawing up of code of conducts intended to contribute to the proper implementation of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises.”
Clinical research is a field with highly specific features, where a number of dedicated Regulations apply, and the vast majority (over 90%) of Service Providers for Clinical Research, also known as “CROs” – Contract Research Organizations” are micro, small and medium-sized enterprises.
All stakeholders, including the largest CRO organizations that are regional or global players, favor higher harmonization across the European Members States…