The activities of the Data Centre, the operating centre that coordinates all of the Foundation’s research activities, are performed according to a Quality System that is structured around a series of standard operating procedures (SOPs), compliant with international regulations and good clinical practice (GCP), that guarantee the consistency, effectiveness and uniformity of the activities performed within the facility. These SOPs are backed by the system procedures that establish the operating processes of the Data Centre infrastructure.
As a result of the recurrent external validation processes, the Data Centre is certified according to the EN ISO 9001:2015 standard for activities related to the “Design, implementation and management of clinical trials” and for the “Design and provision of events and training courses”.
ECRIN Certification
Since 2015 the Data Centre is one of the Clinical Trial Units certified at a European level by the ECRIN consortium for its capacity to provide data management services in clinical studies that are compliance with regulations, effective and efficient.
The certification programme assesses the unit’s compliance to ECRIN quality standards by carrying out an audit on the data management activities of the unit and IT infrastructure used to support these activities.
In 2021, following a second audit, the certification was renewed for another five-year cycle.