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.
The EUCROF Code addresses the need for continuous improvement of quality, security and confidentiality management, to foster transparency and create trust, in a technology driven domain with many new players and growing involvement of patients.
“The EUCROF Code has been designed as a practical tool to enable all CRO organizations comply with GDPR in a harmonized and acknowledged way across all EU Member states”, says Yoanni Th. Matsakis, chairman of the EUCROF Code Task Force, member of the Board & treasurer.
“The introduction in the formal approval process, as defined in the Guidelines 1/2019 on Codes of Conduct and Monitoring Bodies under Regulation 2016/679 of the European Data Protection Board (EDPB) is a great achievement for clinical research in Europe, and the result of a 3 years effort backed by all our members” says Dr. Martine Dehlinger-Kremer, President of EUCROF.
“This initiative has been a formidable opportunity to engage high quality and fruitful collaborations with many stakeholders of clinical research including patient associations, pharmaceutical laboratories and academic networks. The submission for approval is a major milestone and the beginning of a new phase that will result in the establishment of an independent governance body that will ensure the monitoring of the Code and will be accredited by CNIL” says Dr. Stefano Marini, vice-President of EUCROF.
EUCROF is a not-for-profit legal entity registered in the Netherlands whose objectives are, among others, to contribute to high quality Clinical Research in humans and to promote the excellence of European Clinical Research to the public and the media, as well as on the international stage.
The members of EUCROF are national CRO associations as well as individual CROs established in one or more European countries or outside Europe, as defined in its Bylaws. Today EUCROF has more than 380 affiliated companies, in 25 countries. The list of EUCROF members, as well as EUCROF Bylaws, are public and can be freely downloaded from EUCROF’s website (www.eucrof.eu).
Day to day management and representation of the Federation is performed by an Executive Board (EB) consisting in a group of elected executives (President, Vice-President, Secretary, Treasurer, Executive Board member). Executive Board mandates are for 2 years.
EUCROF’s financial resources come (a) first from the regular annual fees paid by its members, (b) ad hoc complementary budget lines contributed by its members and affiliates on a voluntary basis, to subsidise strategic initiatives and (c) income from the training and educational programmes and events sponsored and organized by EUCROF.
EUCROF develops its activities through working groups consisting in subject-matter experts selected among the affiliated CROs and contributing on a voluntary basis.
About the EUCROF Code International Task Force
The EUCROF Code has been drafted by a dedicated international task force, established under the umbrella of the New Technologies Working Group of EUCROF. This task force has widely consulted the EUCROF affiliates, as well as representatives of other stakeholders: pharmaceutical industry, patient associations, medical devices companies, representatives of ethics committees, representatives of various academic organizations, lawyers specialised in electronic health systems, as well as experts in ISO certifications.
Chairman: Yoanni Th. Matsakis, member of the EUCROF Board, AFCROs – France
Co-chairman: Kate Smirnova, Switzerland
Members: Victoria Watts (UK), Emmanuel Dammigos (ISO consultant, Greece), Christine Fayol-Paget (AFCROs – France), Natasa Spasic (Germany), Tim Chulindra (USA), Thierry Lepoutre (BeCRO – Belgium), Konstantina Pateli (HACRO – Greece), Jessica Pepe (AICRO – Italy), Ignacio Jimenez (Spain), Dora Talvard (Lawyer, France), Josephine Flament (Lawyer, France), Marta Lettieri (AICRO – Italy).
More info at: www.eucrof.eu
Contacts: Please send an email at firstname.lastname@example.org, at the attention of Yoanni Th. Matsakis & Kate Smirnova and with subject “EUCROF Code”.
*Commission Nationale de l’Informatique et des Libertés