The European CRO Federation (EUCROF) announces the launch of its electronic submission and approval platform for future adherents to the EUCROF GDPR Code of Conduct for Service Providers in Clinical Research (the EUCROF Code).
In March 2021, EUCROF announced the submission of its EUCROF Code to the CNIL (Commission Nationale de l’Informatique et des Libertés), the French Data Protection Authority as the competent supervisory authority. Since then, the EUCROF Code has advanced through the approval procedures as described in 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”.
The EUCROF Code has already had successful reviews by the CNIL, the APD (Autorité de Protection des Données – the Belgian Data Protection Authority) and BayLDA (Bayerisches Landesamt für Datenschutzaufsicht – the Bavarian Data Protection Authority) and is currently undergoing scrutiny from all Data Protection Authorities in the European Union, before it can receive final approval from the European Data Protection Board (EDPB).
In parallel, the Monitoring Body of the EUCROF Code is being formulated and its procedures codified, ahead of its accreditation by the CNIL. EUCROF anticipates that the EUCROF Code, and its associated Monitoring Body, shall become operational in the second quarter of 2022.
More about the EUCROF Code: download the full presentation note
In anticipation of the completion of the approval processes, whereby the EUCROF Code will become an operational transnational GDPR Code of Conduct, EUCROF has developed an electronic submission and approval platform (IT Platform).
“EUCROF has provided this method for early engagement in order to assist CROs that wish to demonstrate their GDPR compliance as soon as possible”, says Yoanni Th. Matsakis, chairman of the EUCROF Code Task Force, Treasurer and member of the EUCROF Board.
The EUCROF Code IT Platform permits CROs to get early access to the documents of the EUCROF Code and begin their application process to become an adherent to the Code. This way, the electronic submission platform contributes to the adoption of the EUCROF Code on a practical level by allowing interested CROs to progress in the preparation of their adherence dossiers at their own pace.
The IT Platform can be found at https://cro.eucrof.eu/eucrof-code-public-registry and is available to be used by CROs to gain access to the EUCROF Code, begin the process of submitting their application and provide their documentary evidence of GDPR compliance.
Once the EUCROF Code receives its final approval by the EDPB, the submitted application packages of such CROs shall be considered on a first‑come‑first‑served basis to benefit the early adopters.
About the European CRO Federation
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 400 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, as well as events 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. Throughout the drafting process the task force has widely consulted the EUCROF affiliates, as well as representatives of other stakeholders from the pharmaceutical industry, patient associations, medical devices companies, ethics committees, and various academic organizations, lawyers specialised in electronic health systems, as well as experts in ISO certifications.
More info at: www.eucrof.eu
Contacts:
Please send your enquiries to info@eucrof.eu for the attention of EUCROF Code Management and with subject “EUCROF Code”.
January 12, 2022
