临床试验管理证书(研究生)|亿德体育-亿德体育

Clinical Trial Management Certificate

The Clinical Trial Management Certificate in the School of Pharmacy 亿德体育是专门为积极参与临床试验过程的制药和医疗保健专业人员设计的, including physicians, clinical research monitors, investigators and coordinators, or members of investigational review boards (IRBs). This certificate is part of the School of Pharmacy’s 法规事务(RA)和质量保证(QA)研究生课程.

这个研究生课程提供了了解新药发现基础所需的工具和信息, 临床方案的设计与实施, its conduct and effective monitoring strategies, 并对数据进行审核，保证试验的完整性. Specific courses emphasize protocol development, 临床研究的生命伦理与人体研究主体的保护, informed consent form and process, clinical operations, 以及主要人员——内部审查委员会的作用和责任, sponsor, monitor, 合同研究组织(CRO)和临床研究者.

临床试验管理证书使学生能够在研究生课程设置中提高他们的临床试验知识，而无需完成整个硕士学位. 它提供了工具和信息，以了解如何在制药工业中设计和监督临床试验, including writing protocols and consent forms, 深入研究良好临床实践的要求, and managing budgets and data.

More than 60 courses are offered online in real time. 临床试验管理证书可以完全在线进行. 考生必须完成规定的课程和申请手续才能获得证书.

药学院法规事务与质量保证

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA.

The School of Pharmacy

pioneered RA and QA graduate education in 1968, 开设第一个RA和QA在线学位课程，并提供最全面的RA和QA课程;
拥有来自工业界和美国的优秀专家教师.S. 美国食品和药物管理局(FDA)，确保教授最新的发展和实践;
attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare);
安排现场课程，在晚上和周末进行互动讨论和研讨会;
has hundreds of students from across the country, facilitating great networking opportunities; and
provides individualized services to students.

证书提供坦普尔备受尊敬的RA和QA研究生课程的证书, 哪些可以适用于RA和QA硕士学位.

Program Format & Curriculum

临床试验管理证书可以自行获得，也可以在获得临床试验管理证书的过程中获得 MS in RA and QA. To earn the certificate, 以下五门课程必须在四年内顺利完成，总成绩为B (3).0) average.

Drug Development (5459)
Good Clinical Practices (5536)
临床试验管理(5537)或全球临床药物开发(5539)
Bioethics for Pharmaceutical Professionals (5612)
Statistics for Clinical Trials (5497) or Clinical Drug Safety and Pharmacovigilance (5538) or Project Management for Clinical Trials (5547) or 医疗保健产品中的风险管理和安全信号(5578) or Clinical Data Management (5618)