Description

Litton, Jennifer.Four semester hours.秋季和春季，每年取决于兴趣。评分系统：通过或失败。Prerequisite: consent of course director.

本课程将包括21 hours of lecture. The lectures will teach the basic research concepts and principles that underlie the design and actual day-to-day conduct of clinical trials using examples primarily from cancer trials. Topics include the nature of disease and its impact on research protocol design, appropriate statistics to use, medical terminology frequently encountered in clinical research, methods to monitor human subjects’ response to treatment, monitoring of clinical research laboratories; rules and regulations (including the Office of Human Research Protections, the Federal Drug Administration, and the state), and ethical concerns related to clinical trials

Three practicums, 24 hours each, will be available to students. Each student must complete two. The practicums include:

(1) Topics in Regulatory and Ethical Concepts in Human Subjects Research within the Office of Protocol Research/Institutional Review Board (IRB) Office.

学生将与M.D Anderson的协议研究/IRB办公室工作人员一起工作，以研究该办公室使用的运营过程，以允许应用知情同意程beplay苹果手机能用吗序并遵守监管​​指南。学生将在人类受试者研究的道德进化和应用方面进行入门。beplay苹果手机能用吗学生将通过遵循涉及人类受试者的研究协议的科学和道德审查过程来将这些原则和法规应用于经验，从而帮助确保他们的全面理解，该过程涉及从构想到终止的人类受试者，遵循从科学审查到IRB审查过程的协议。beplay苹果手机能用吗

(2) Topics in Compliance and Auditing of Responsible Conduct of Research within the Office of Research Education and Regulatory Management.

Students will receive advanced instruction in the principle areas of monitoring and auditing clinical trials to ensure compliance with Responsible Conduct of Research as defined by the US Public Health Service that specifically apply to clinical trials and human research. Students will conduct a project within this office where they will follow an investigational new drug (IND) application.

(3) Topics in Data Management in Cancer Clinical Trials within the Phase I Program.

将教授学生在临床试验中收集和解释数据的方法，以及确保数据安全和患者机密性的要求和方法。学生将学习如何监督/协调临床试验的实际数据收集和监测方面。学生将在MD Anderson正在进行的课程主任和董事/协调员的指导下，作为临床试验项目团队的成员参加。