WP 3 – Clinical study implementation and operations

This work package will be led by P1vital and BI. P1vital will ensure that WP3 is conducted to the highest standards of Good Clinical Practice (GCP), on time and within budget. P1vital will be responsible for the overall study management including all preparation for all documentation related to the set up and execution of the clinical trial. They will also be responsible for study setup, site training, recruitment management and completion of the clinical investigation and the development, deployment, and standardization of relevant behavioural and fMRI paradigms. Where possible deployment of self-report questionnaires and behavioural tasks within the clinical trial will be via the online P1vital ePRO clinical system, as was the case in the original PRISM clinical study, ensuring high and standardized data quality and allowing easier data management across the assessment battery. P1vital will also be responsible for the providing data from the clinical study to the Brains Commons platform (WP2).

BIOTRIAL will be responsible for the development, deployment and standardization of EEG paradigms for the study. Together these two SMEs will provide a strong basis for the setup, execution and completion of the planned clinical investigation. Clinical sites will be responsible for the development, deployment and standardization of rs-fMRI and Diffusion Tensor Imaging (DTI) fMRI for the study. The total number of subjects will be comparable to those recruited in PRISM (N=160) and they will be recruited and assessed over two days. On Day 1 the participants will be screened and complete clinical interviews, questionnaires, provide blood samples, and install the BEHAPP smartphone app; on Day 2 the EEG and fMRI procedures will be performed. CIBER (Study sponsor), VUMC, and LUMC will be responsible for recruitment and deep-phenotyping of all participants (Note that CIBER includes 2 clinical sites (already included in PRISM): Hospital General Universitario Gregorio Marañón and Hospital La Princesa). BI will assist with protocol development and review and provide pre-final protocol approval on behalf of the EFPIA stakeholders. Final protocol approval will be provided by the PRISM 2 Steering Committee.