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Multicenter Trial Management

YCCI has instituted multiple services to support Yale investigators who wish to design, propose, and execute investigator-initiated multicenter studies. For several years, YCCI has provided assistance upon request for PI's who head investigator-initiated multicenter studies, but this capability has now expanded into a full-service line for Yale investigators who lead multicenter studies. YCCI helps develop management plans and case report forms built in OnCore that can enable electronic data capture from remote sites, so that these complex studies can be carried out in much the same way that pharmaceutical trials are conducted.

YCCI provides monitoring through its Quality Assurance office and can set up Data and Safety Monitoring Boards and help conduct those meetings. YCCI can provide the monitoring services or help to screen, interview, and hire contract monitors.

Providing these centralized services, which are being launched as a major initiative with the Yale Cancer Center, allows YCCI to retain institutional knowledge and expertise about the conduct of multicenter trials at a central source, providing an economic alternative to hiring ad hoc staff members who may lack experience with this type of research.