CLINICAL RESEARCH METHODOLOGY CURRICULUM

临床研究课程奖（CRCA）的竞争申请，响应RFA OD-98-007，寻求在纪念斯隆-凯特琳癌症中心（MSKCC）建立一个教学临床研究方法论课程。拟议的两年课程将使学员全面了解生物统计学、临床研究方法、研究伦理和有关人类研究的监管问题。来自医学、外科、儿科、人类遗传学、流行病学和生物统计学、放射肿瘤学、神经病学和精神病学等部门的教师将参与教学课程，客座教授将提供经济成果研究和管理人类研究的联邦法规方面的专业知识。该课程包括三门必修课程：临床研究生物统计学核心课程；临床研究中的伦理问题；临床研究方法论核心课程。学员将被要求参加课程内容的笔试，并提交其学科的临床研究书面方案，以满意地完成CRCA。项目主任将负责CRCA的实施，协调CRCA的三个核心课程，作为课程教员积极参与，并向咨询委员会报告CRCA。重点教师将帮助协调个别系列研讨会，并作为课程教师积极参与。预计每年将从25个基于mskcc的培训项目和11个mskcc联合培训项目的学员中选出大约60名学员参加CRCA。具有临床研究或转化研究能力和/或有临床研究潜力的学员将被确定为CRCA的成员。CRCA为未来的临床研究人员提供了多学科、综合的教学课程，为参与者提供了临床研究培训材料纲要的必要支持，为监测CRCA毕业生的学术研究活动提供了资源，并为学员对课程的理解提供了便利，为进一步改进教育计划提供了基础。

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.