The responsibilities within the MCRO office purview include:

·       Central Registration Services, including management of the study specific registration table and ensuring compliance with regulatory procedures prior to subject registration.

·        Facilitate external site feasibility review, start-up, and activation for multicenter IITs, including sponsor review of site-specific consent forms and preparation of the site-specific regulatory file.

·       Distribute updated study materials and new information to external sites and maintain adequate regulatory records from each participating site.

·       Ensure all participating sites are promptly informed of significant new adverse effects or risks with respect to the investigational product and/or device.

·       Facilitate external site budget and contract development for multicenter IITs, including establishing drug depots.

·       Coordinate investigational product and device shipment to external sites for multicenter IITs.

·        Prompt reporting of external site Serious Adverse Events (SAEs), Unanticipated Problems (UPs), and Protocol Deviations (PDs) to the appropriate regulatory committees and pharmaceutical partners.

·        Develop lab manuals, protocols, and study material for multicenter IITs.

·        Review invoices from external sites to facilitate payments.

·        Complete milestone reporting requirements for pharmaceutical partners.

·        Lead teleconferences for multicenter IITs with Principal Investigators and external partners.

·        Complete external site close-out activities for multicenter IITs once the clinical trial is complete and/or all external patients are off study.