Clinical Trial Management Certificate

The Clinical Trial Management Certificate in the School of Pharmacy at Temple University is specifically designed for pharmaceutical and healthcare professionals who actively contribute to the clinical trial process, 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 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, its conduct and effective monitoring strategies, and the auditing of data to ensure the integrity of the trial. Specific courses emphasize protocol development, the bioethics of clinical research and the protection of the human research subject, informed consent form and process, clinical operations, and the role and responsibilities of the key personnel—the IRB, sponsor, monitor, contract research organization (CRO) and the clinical investigator.  

The Clinical Trial Management Certificate 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 in the pharmaceutical industry, including writing protocols and consent forms, delving into the requirements of good clinical practices, and managing budgets and data. 

More than 60 courses are offered online in real time. The Clinical Trial Management Certificate may be pursued entirely online. Candidates must complete the required courses and application procedures to receive the certificate.

Program Format & Curriculum

The Clinical Trial Management Certificate may be earned on its own or on the way to the MS in RA and QA. To earn the certificate, the following five courses must be successfully completed within a four-year period with an overall B (3.0) average.  

• Drug Development (5459) 

• Good Clinical Practices (5536)  

• Clinical Trial Management (5537) or Global Clinical Drug Development (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 Risk Management and Safety Signaling in Healthcare Products (5578) or Clinical Data Management (5618) 

All courses must be completed from Temple University’s RA and 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 Temple University’s Clinical Trial Management Certificate in its place. The request to waive a Temple course must be submitted and approved by the assistant dean of RA and QA before starting the program. 

Students interested in pursuing the RA and QA MS program may apply all credits earned from the Clinical Trial Management Certificate towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school.

Learn more about the Clinical Trial Management Graduate Certificate.

See the curriculum.

Requirements 

• To be considered for the Clinical Trial Management Certificate, 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, photocopies of transcripts and Notice of Completion). 

• Only one certificate may be completed before students receive the MS. Students must complete the Clinical Trial Management Certificate within four years. 

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

Learn more about the application process.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS