CLINICAL RESEARCH METHODOLOGY CURRICULUM

这项临床研究课程奖(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。拟议的两年制课程将为学员提供对生物统计学、临床研究方法、研究伦理和人类研究的监管问题的透彻了解。来自内科、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的教员将与客座教员一起参加教学课程，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。CRCA包括三门为学员开设的必修课：临床研究生物统计学核心课程；临床研究伦理学；以及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，并提交其学科临床研究的书面方案，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。关键学院将帮助协调个人系列研讨会，并作为课程教员积极参与。预计每年将从25个MSKCC培训项目和11个MSKCC联盟培训项目的学员中挑选约60名学员参加CRCA。已经在临床研究或转译研究和/或有希望的临床研究潜力方面表现出能力的受训人员将被确定为CRCA。CRCA为未来的临床研究人员提供了一个多学科的、综合的教学课程，为参与者的临床研究培训材料纲要提供了必要的支持，为CRCA毕业生的学术研究活动提供了资源，并促进了对学员对课程理解的评估，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.