Office of Research Services

The ORS comprises PCIR (Nursing) Protocol & Regulatory Education & Training Biostatistics Informatics Budgets & Contracts Recruitment

Office of Research Services (ORS)

The new Office of Research Services (ORS) is a key innovation that provides the infrastructure that supports The Yale Center for Clinical Investigation‘s (YCCI’s) mission to provide “one stop shopping” for clinical and translational investigators by housing at one site all of the support and service personnel that are needed for every aspect of cutting-edge studies. The aims of ORS are to:

• integrate and enhance the high quality of clinical and translational research conducted at Yale University
• develop strategies to address the current and changing needs of clinical and translational researchers
• maximize the potential of existing resources; to streamline the regulatory approval process for the investigator
• improve investigator knowledge about regulatory requirements and guide them through the process
• provide a central system that will document regulatory compliance and completion of required training modules; and to enhance the quality of interactions with human subjects 

The primary aims of this support unit are to provide support to investigators and their research teams that will promote the protection of human subjects and facilitate and document regulatory compliance. Through the development of innovative practices, we will reduce or remove obstacles to clinical and translational research at Yale and enhance the opportunities for collaboration with other institutions, NIH and industry. This infrastructure is not intended to and will not replicate existing regulatory compliance functions or expertise. Regulatory compliance is currently overseen by a University Regulatory Compliance Committee constituted under the Office of the Provost. Individual regulatory offices are responsible for assuring a broad spectrum of regulatory programs in support of their missions.

The ORS Regulatory Knowledge and Support Unit provides “research-focused” support for regulatory compliance and clinical research management to our investigators and their teams.  Functionally it provides:

• Knowledge -- Maintaining broad-based  information on federal, state, local and institutional requirements to initiate and manage clinical research, including all regulatory requirements; detailed knowledge about specifics for implementation of research at Yale and at affiliated sites; and the location, contact, and procedures of the compliance offices and regulatory agencies.
• Service -- Providing consultation services for investigator and staff with direct hands on service in support of the preparation of clinical protocols and grant proposals and contracts.
• Education -- Providing a robust system to educate and update personnel involved in clinical and translational research concerning all aspects of regulatory matters