临床试验管理证书

的 临床试验管理证书 在 药学院 at 亿德体育 is specifically designed for pharmaceutical and healthcare professionals who actively contribute to the clinical trial process, 包括医生, 临床研究监测器, 调查人员和协调员, 或研究审查委员会(irb)成员. 这个证书是药学院颁发的 regulatory affairs (RA) and quality assurance (QA) graduate program. 

This graduate program provides the tools and information needed to understand the basis for new drug discovery, the design and implementation of the clinical protocol, 其行为和有效的监测战略, and the auditing of data to ensure the integrity of the trial. 特定课程强调协议开发, the bioethics of clinical research and the protection of the human research subject, 知情同意书及程序, 临床操作, and the role and responsibilities of the key personnel—the IRB, 赞助商, 监控, contract research organization (CRO) and the clinical investigator.  

的 临床试验管理证书 enables students to sharpen their knowledge of clinical trials in a graduate program setting without committing to the entire master’s degree. It provides the tools and information to understand how clinical trials must be designed and overseen 在 pharmaceutical industry, 包括撰写协议和同意书, delving into the requirements of good clinical practices, 管理预算和数据. 

在线实时提供60多种课程. 的 临床试验管理证书 may be pursued entirely online. Candidates must complete the required courses and application procedures to receive the certificate.

程序的格式 & 课程

的 临床试验管理证书 may be earned on its own or on the way to the 在RA和QA部门担任硕士. 要获得证书, the following five courses must be successfully completed within a four-year period with an overall B (3.0)平均.  

• 药物开发(5459) 

• 良好临床规范(5536)  

• Clinical Trial Management (5537) or Global Clinical Drug Development (5539) 

• 制药专业人员的生命伦理学(5612)

• 临床试验统计(5497) or 临床药物安全及药物警戒(5538) or 临床试验项目管理(5547) or Risk Management and 安全 Signaling in Healthcare Products (5578) or 临床数据管理(5618) 

All courses must be completed from 亿德体育’s RA和QA graduate program. No transfer credits from other institutions are accepted. Students who have completed similar courses at other institutions may request that a course be waived and take another elective from 亿德体育’s 临床试验管理证书 in its place. 的 request to waive a Temple course must be submitted and approved by the assistant dean of RA和QA before starting the program. 

Students interested in pursuing the RA和QA MS program may apply all credits earned from the 临床试验管理证书 towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by 亿德体育’s graduate school.

Learn more about the Clinical Trial Management 研究生 Certificate.

参见课程设置.

需求 

• To be considered for the 临床试验管理证书, candidates must have a bachelor’s degree from an accredited institution of higher learning. 

• Candidates must formally apply and follow the application procedures (application form, 成绩单及完成通知书影印本). 

• Only one certificate may be completed before students receive the MS. Students must complete the 临床试验管理证书 within four years. 

• Students must apply for the certificate within one year of completing all required coursework for the program.

了解更多有关申请流程的信息.

相关研究生学位

• 法规事务和质量保证硕士