Abstract

The certification scheme aims to improve efficiency and expedite the site selection process for clinical trials and studies and maximise the number of high-quality trial-ready sites. It provides an opportunity for sites to register their interest and ability to participate in trials and increases the visibility of potential trial sites for sponsors and clinical study teams. The scheme reduces the administrative burden for sites and sponsors during trial set-up by centrally storing information about site feasibility, training, qualifications and experience and providing these details to approved sponsors. Guidance and support is provided for less experienced sites to become trial-ready.

Certification requires that sites meet a specific set of criteria designed to assess clinical trial readiness including general site information, clinical trial infrastructure, patient cohort, training and education. The scheme is open to Enroll-HD and non-Enroll-HD sites in Australia, Europe, Latin America, North America, New Zealand, Nordic regions and Russia.

The core information for the certification application is collected using the GSID-HD (HD Global Site Investigator Database) and requires the submission of a standard set of documents and SOPs for review. For further information contact hdsite@euro-hd.net.