Work package 3 (WP3) within the PRISM 2 project focuses on the implementation of the clinical study and its operations. It is coordinated 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, and will be responsible for the overall study management, including 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 standardisation of relevant behavioural and functional Magnetic Resonance Imaging (fMRI) paradigms. Where possible, deployment of self-report questionnaires and behavioural tasks within the clinical trial will occur via the online P1vital ePRO clinical system as was the case in the original PRISM clinical study, ensuring high and standardised data quality and allowing easier data management across the assessment battery. P1vital will also be responsible for providing data from the clinical study to the Brain Commons platform (WP2). BIOTRIAL will be responsible for the development, deployment and standardisation of electroencephalogram (EEG) paradigms for the study. The clinical sites will be responsible for the development, deployment and standardisation of rs-fMRI and Diffusion Tensor Imaging (DTI) fMRI for the study. CIBER (study sponsor), VUMC, and LUMC will be responsible for recruitment and deep-phenotyping of all participants. BI will assist with protocol development and review and provide pre-final protocol approval on behalf of the EFPIA stakeholders. Final protocol approval will occur by the PRISM 2 Steering Committee (SC).
