CLINICAL RESEARCH METHODOLOGY CURRICULUM

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This competing application for the Clinical Research Curriculum Award (CRCA), in response to RFA OD-98-007, seeks to establish a didactic Clinical Research Methodology Curriculum at Memorial Sloan-Kettering Cancer Center (MSKCC). The proposed two-year curriculum will provide to trainees a thorough understanding of biostatistics, clinical research methodology, research ethics and regulatory issues governing research on human subjects. Faculty from the Departments of Medicine, Surgery, Pediatrics, Human Genetics, Epidemiology and Biostatistics, Radiation Oncology, Neurology, and Psychiatry will participate in the didactic curriculum with visiting faculty providing expertise on economic outcomes research and federal regulations governing human research. The CRCA includes three required courses for trainees: Biostatistics in Clinical Research Core Course; Ethics in Clinical Research; and a Clinical Research Methodology Core Course. Trainees will be required to take written exams on course content and submit a written protocol for clinical research in their discipline for satisfactory completion of the CRCA. The Program Director will assume the responsibility for implementation of the CRCA, coordinate the three Core Courses of the CRCA, actively participate as a curriculum faculty member and report on the CRCA to the Advisory Committee. Key Faculty will help coordinate the individual seminar series, as well as actively participate as curriculum faculty members. It is expected that approximately 60 trainees each year will be selected for the CRCA from trainees in 25 MSKCC-based and 11 MSKCC-consortium training programs. Trainees who have already demonstrated ability in clinical investigation or translational research and/or promising clinical research potential will be identified for the CRCA. The CRCA makes possible a multi-disciplinary, comprehensive didactic curriculum for future clinical research investigators, provides necessary support for a compendium of clinical research training materials for the participants, provides resources to monitor scholarly research activity of the CRCA graduates, and facilitates assessment of the trainees' comprehension of the curriculum, providing a basis for further improvement in the educational program.