On 10 June 2021 ECRIN opened its call for applications to its Data Centre Certification programme. ECRIN’s Data Centre Certification programme is ISO 9001:2015 certified and was developed to audit European, non-commercial data centres using ECRIN IT/DM standards, to confirm their ability to provide compliant, effective, and efficient data management services for controlled clinical trials. The goal is to enhance high-quality data management services in non-commercial clinical trials and to contribute to the harmonisation of European data management practices.
Applicant centres have until 27 September 2021 to complete their application. Applications are open to centres within the ECRIN national scientific partners. Approval by the head of the national network is required. The application process includes the completion of an online questionnaire with confirmation of readiness for audit by the ECRIN Independent Certification Board Secretary (ICB).
An audit team will then be assembled and will conduct either an onsite or remote audit in English (where possible with an auditor that speaks the national language). The final decision on the certification of the centre lies with the ICB. Where certification is successful, it will be granted for 4 years.
For full details on the application procedure and the ensuing certification process visit the Data Centre Certification programme webpage.