Early Phase Clinical Research Support

$150,385P30FY2015CANIH

Columbia University Health Sciences, New York NY

Investigators

Linked publications & trials

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Abstract

The Early Phase Clinical Research Support (EPCRS) program at Herbert Irving Comprehensive Cancer Center (HICCC) helps support a wide range of innovative, feasibility, or proof of principle trials originating from its translational research programs and initiated by institutional Pi's. EPCRS is supported, administratively by the Clinical Protocol and Data Management (CPDM) office (formerly the Clinical Research Management Office, or CRMO), which centrally administers the Implementation and conduct of early phase clinical research studies. CPDM time and effort includes, but is not limited to: research nursing, research coordination, quality control and monitoring, IND/IDE applications, and other regulatory functions. EPCRS trials exemplify the accomplishments of translational programs at HICCC and are dedicated to developing new therapies and testing them In the clinic. This process has evolved and now serves the function of stimulating clinical research activity. The CPDM provides infrastructure, and highly skilled staff, which is essential to the success of the EPCRS. The advanced medical acuity of patients in early phase trials, the dramatically increased reporting requirements for organizing tests, treatments, insurance approvals, and assisting in all aspects of patient care, the requirements to become familiar with novel agents, methods of administration, and toxicity evaluations all demand a centralized resource under a single reporting structure, while promoting the opportunity for continuing education and state-of-the-art IT support.

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