F70 Enroll-hd platform services

Abstract

Enroll-HD is a global research platform. Key elements of the platform’s infrastructure include global study management and governance, standardised informed consent forms (ICFs) and site contracts, uniform clinical site training, an integrated EDC and study database and a user-friendly comprehensive webportal. This infrastructure supports the Enroll-HD study, a prospective, observational, longitudinal registry study of HD, currently with >17,000 participants who have performed standardised clinical assessments and biosample collections from annual visits at over 160 clinical sites in 17 countries. Resources and services of the platform that are made available to the HD research community include easily accessible periodic clinical datasets and associated biosamples. Consequent research output may be used to support future clinical studies, including protocol design. A team of subject matter experts (SMEs) with experience in activities such as ICF development and translation, site agreements and financial payments, insurance, assessment scale licencing, IRB/ethics submissions, site staff training and certification via the platform training portal, database construction, and data monitoring is available to assist in the implementation of clinical studies. Long term working relationships with the participating clinical sites allow for well-informed clinical trial site selection and efficient feasibility as well as ongoing support for issue resolution and trial facilitation. The Enroll-HD platform’s substantial registry of participants allows for powerful in-silico screening to support participant recruitment. A toolkit of platform resources, procedures and template documents is in preparation. The provision of platform services, including the SME support, is managed by a team of Project Resource and Service Managers (PRSM Team). This team also facilitates the interface between clinical study and trial project teams or researchers and the Enroll-HD Platform.