Clinical Protocol and Data Management

The Office of Clinical Research is the Clinical Protocol and Data Management Core Facility. Our key function is to provide central management, support and oversight functions for the conduct of cancer-related clinical research studies across the Temple Health – Fox Chase Cancer Center campus, institutional locations and affiliates. The Office of Clinical Research is a centralized resource that trains and assists clinical investigators with the development, submission, activation, management and reporting of study results.

Protocol Development for Investigator Initiated Trials (IITs) is an institutional priority, inclusive of the Extramural Research Program. The clinical trial development project manager (PM) assists investigators in writing the clinical trial protocol, corresponding with industry collaborators and engaging with external trial sites. The PM works with investigators either from the point of initial protocol concept initiation or protocol draft, assisting in the writing of the study plan, eligibility criteria, investigational agent information, assessments, adverse events, measurement of effect and administrative sections, as well as the Data Safety and Monitoring Plan.

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