MASTER OF SCIENCE DEGREE IN CLINICAL INVESTIGATION

说明：说明应用程序的广泛、长期目标和具体目标，并参考该项目与健康相关的内容。描述 简明扼要地介绍实现这些目标的研究设计和方法。避免总结过去的成就和使用第一人称。这篇摘要 是为了在脱离应用程序时对提议的工作进行简洁而准确的描述。如果应用程序得到资助，则此 原样的描述将成为公开信息。因此，不包括专有/机密信息。不要超过空格 但前提是。 这项申请是位于圣安东尼奥的德克萨斯大学健康科学中心的竞争续订 (UTHSCSA)临床研究课程奖(NHLBI K30 HL04159)。在过去的3年里，我们 成功建立了新的临床调查理学硕士(MSCI)学位课程，并 招收了26名不同的学生；5名(19.2%)已经成功获得同行评审 拨款。通过此应用程序，我们试图实现两个具体目标：1)提高和扩大质量 为UTHSCSA所有5个博士后、毕业生和教职员工提供临床研究培训 2)进一步增加学生在种族和专业背景方面的多样性， 受过临床研究指导方面的培训。我们实习生的“实验室”是普通临床研究 中心，这是一个由NIH资助的中心，位于我们的一家教学医院。通过与我们的西班牙裔中心联系 优秀，不同种族学生的数量，特别是墨西哥裔美国人和其他西班牙裔美国人 在临床研究方面接受培训的小组将继续增加。一旦接受培训，该项目的毕业生将被 擅长设计和实施以病人为中心的调查。MSCI计划的指导者 是否在分子生物学、蛋白质化学、细胞生物学和临床方面拥有活跃的课程？ 研究，并在运行成功的研究计划、研究教育方面拥有被证明的专业知识的人 方案，以及在获得外部赠款支助方面。由于大多数医学博士缺乏正规的教学培训 作为这一领域博士项目的特色，我们已经建立了一个有组织的项目来准备我们的 受训人员成为未来的独立临床研究人员。MSCI学员完成导师指导的研究项目 参加一套综合的11门教学课程超过2年：(A)研究方法(3 (B)生物统计学(3学期)；(C)负责任的研究(1学期)；(D) 将分子生物学融入临床研究(1学期)；(E)数据管理和质量 控制(1个学期)；(F)科学写作(1个学期)；和卫生服务研究(1个学期--一个新的 本申请中建议的课程)。我们的目标是不断改进调查人员的准备工作 擅长在不同文化背景下进行杰出的临床研究。MSCI计划 有效性将通过监测一套连贯的4项主要成果来确定。这些结果是 (A)继续从事临床研究职业(及其角色)的毕业生人数；(B) 成功竞争职业发展和研究奖项；(C)经同行评审的科学出版物 (D)从事指导其他临床研究人员的毕业生。 演出现场(S)(组织、市、州) 德克萨斯大学圣安东尼奥健康科学中心，德克萨斯州圣安东尼奥弗洛伊德·柯尔大道7703号，邮编：78229-3900. 关键人员。请参阅说明。根据需要使用续页，以如下所示的格式提供所需信息。 从首席调查员开始。按字母顺序列出所有其他关键人员，姓氏在前。 命名项目中的组织角色 迈克尔·J·利希滕斯坦大学医学院项目主任 Jacques Baillarjo UTHSCSA-医学院课程负责人-生物统计学 John Cornell UTHSCSA-医学院课程负责人-生物统计学 莎伦·福勒UTHSCSA-医学院课程联合负责人-数据管理 Goutam Ghosh-Choudhury UTHSCSA-医学院课程联合负责人-分子生物学 安吉拉·汗UTHSCSA课程负责人-负责任的行为 UTHSCSA-研究生院课程联合负责人-方法 Polly Noei-Hitchcock UTHSCSA-医学院课程联合负责人-卫生服务研究 Michael Parchman UTHSCSA-医学院课程联合负责人-卫生服务研究 布拉德·波洛克UTHSCSA-医学院课程联合负责人-生物统计学 Jacqueline Pugh UTHSCSA-医学院课程负责人-卫生服务研究 Steven Schenker UTHSCSA-医学院课程负责人-负责任的行为 UTHSCSA约翰·斯库尔菲尔德-学术信息学课程联合负责人-生物统计学 Zelton Dave Sharp UTHSCSA-医学院课程负责人-科学写作 Linda A.Smith UTHSCSA-联合健康学院分子生物学课程联合负责人 迈克尔·P·斯特恩UTHSCSA-医学院课程负责人-数据管理 肯尼斯·威廉姆斯UTHSCSA-医学院课程联合负责人，数据管理 小灵通398(05/01版)第_2页表格第2页 首席研究员/项目主任(最后、第一、中间)：利希滕斯坦，迈克尔·J。

DESCRIPTION: State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. This application is a competing renewal for the University of Texas Health Science Center at San Antonio's (UTHSCSA) Clinical Research Curriculum Award (NHLBI K30 HL04159). Over the past 3 years we successfully established a new Masters of Science in Clinical Investigation (MSCI) Degree Program and enrolled a diverse group of 26 students; 5 (19.2%) have already been successful in obtaining peer reviewed grant funding. With this application we seek to achieve 2 specific aims: 1) enhance and expand the quality of clinical research training for post-doctoral students, graduates, and faculty from all 5 of the UTHSCSA's schools, and 2) further increase the diversity of the students, in ethnicity and professional background, trained in the conduct of clinical research. The 'laboratory' for our trainees is the General Clinical Research Center, an NIH-funded center located in one of our teaching hospitals. By linking with our Hispanic Centers of Excellence, the number of ethnically diverse students, particularly Mexican-Americans and other Hispanic groups, trained in clinical research will continue to increase. Once trained, this program's graduates will be expert in the design and conduct of patient-oriented investigations. The preceptors for the MSCI program are faculty members with active programs in molecular biology, protein chemistry, cell biology and clinical research, and who have proven expertise in running successful research programs, research education programs, and in obtaining extramural grant support. Since most MDs lack the formal didactic training characteristic of PhD programs in this arena, we have established an organized program to prepare our trainees as future independent clinical researchers. MSCI candidate complete a mentored research project over 2 years while participating in an integrated set of 11 didactic courses: (a) Research Methods (3 semesters); (b) Biostatistics (3 semesters); (c) Responsible Conduct of Research (1 semester); (d) Integration of Molecular Biology into Clinical Research (1 semester); (e) Data management and Quality Control (1 semester); (f) Scientific Writing (1 semester); and Health Services Research (1 semester - a new course proposed in this application). Our goal is to continually improve the preparation of investigators skilled in the conduct of outstanding clinical research in culturally diverse settings. MSCI program effectiveness will be ascertained by monitoring a cohesive set of 4 primary outcomes. These outcomes are the number of: (a) graduates who continue in clinical research careers (and their roles); (b) graduates who successfully compete for career development and research awards; (c) scientific peer-reviewed publications of the graduates; (d) graduates engaged in mentoring other clinical investigators. PERFORMANCE SITE(S) (organization, city, state) University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229-3900 KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project Michael J. Lichtenstein UTHSCSA-Medical School Program Director Jacques Baillargeon UTHSCSA-Medical School Course Leader-Biostatistics John Cornell UTHSCSA-Medical School Course Leader-Biostatistics Sharon Fowler UTHSCSA-Medical School Course Co-Leader-Data Management Goutam Ghosh-Choudhury UTHSCSA-Medical School Course Co-Leader-Molecular Biology Angela Khan UTHSCSA Course Leader-Responsible Conduct Bettie Sue Masters UTHSCSA-Graduate School Course Co-Leader-Methods Polly NoeI-Hitchcock UTHSCSA-Medical School Course Co-Leader-Health Services Research Michael Parchman UTHSCSA-Medical School Course Co-Leader-Health Services Research Brad Pollock UTHSCSA-Medical School Course Co-Leader-Biostatistics Jacqueline Pugh UTHSCSA-Medical School Course Leader-Health Services Research Steven Schenker UTHSCSA-Medical School Course Leader-Responsible Conduct John Schoolfield UTHSCSA-Academic Informatics Course Co-Leader-Biostatistics Zelton Dave Sharp UTHSCSA-Medical School Course Leader-Scientific Writing Linda A. Smith UTHSCSA-School of Allied Health Course Co-Leader-Molecular Biology Michael P. Stern UTHSCSA-Medical School Course Leader-Data Management Kenneth Williams UTHSCSA-Medical School Course Co-Leader, Data Management PHS 398 (Rev. 05/01 ) Page _2 Form Page 2 Principal Investigator/Program Director (Last, first, middle): Lichtenstein, Michael J.