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Clinical Protocol and Data Management
The Office of Clinical Research (OCR) provides central management, research support and oversight functions for the conduct of cancer-related clinical trials for the Cancer Center. OCR services are provided for all interventional treatment trials conducted within the Cancer Center, including those at the Burholme Campus, FCCC’s Bone Marrow Transplant Unit, Health Science Center Campus, East Norriton and Buckingham. For other cancer relevant clinical research, the OCR facilitates study submission, ongoing management of study materials and annual reviews; however, some researchers utilize research staff within their department to perform the conduct of the study. The OCR has particular responsibility for institutional treatment trials developed by Cancer Center members. Along with the Quality Assurance (QA) group of the OCR, research teams are trained to support the conduct of each trial.
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.