Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Post-Master's Certificate in
Clinical Trial Management
Brochure - Post-Master's Certificate in Clinical Trial Management
- Graduates of our MS in RAQA degree are welcome to complete the Post-Master’s Certificate in Clinical Trial Management.
- Four courses beyond the MS are required to receive this Certificate.
- Courses taken for the completion of the MS degree will not be counted.
- Students must apply for the Certificate before taking any courses. Application
Typically students must complete:
- 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 Data Management (5618) or Clinical Drug Safety and Pharmacovigilance (5538) or Project Management for Clinical Trials (5547) or Risk Management and Safety Signaling in Healthcare Products (5578).
If students have already taken one or more of the above listed courses as part of their MS program of study, they may request to take the following electives as substitutes (see brochure for additional information). Again their program of study must be approved before they proceed with taking courses:
- Fundamentals of Pharmacology and Pharmacokinetics (5401)
- Quality Audit (5494)
- Statistics for Clinical Trials (5497)
- Clinical Drug Safety and Pharmacovigilance (5538)*
- Project Management for Clinical Trials (5547)
- Post Marketing Safety Surveillance (5571)*
- Pharmacoepidemiology (5573)
- Risk Management and Safety Signaling in Healthcare Products (5578)
- Regulatory and Legal Basis of Pharmacovigilance (5579)
- Clinical Aspects of Pharmaceutical Medicine I (5599)
- Clinical Data Management (5618)
*Students may only receive credit for Clinical Drug Safety and Pharmacovigilance (5538) or Post Marketing Safety Surveillance (5571) for either the Clinical Trial Management Certificate or the MS in RAQA. They may not receive credit for both.
Transfer credits are not accepted towards Temple’s certificate programs. Students may receive more than one post-master's certificate.
Masterís Students from Other Accredited Schools in the U.S.
If you did not receive the MS in RAQA from Temple University, you are required to complete five approved courses to receive the Post Master's Certificate in Clinical Trial Management. Please refer to the Brochure regarding course choices.
You must have sufficient industry experience and sufficient familiarity with basic tenets of RAQA to pursue the Temple U Post Master's Certificate in Clinical Trial Management.
You must apply before starting the program. The application must include a letter of request to the Assistant Dean of RAQA, indicating which courses you intend to pursue and citing your industry experience. Application
Include a copy of your resume and a photocopy of your final transcript from the school where you received your doctoral or master's degree.
Send all application materials to:
Temple University RAQA Graduate Program
Attn: Assistant Dean
425 Commerce Drive, Ste 175
Fort Washington, PA 19034
Formal permission to pursue the Post-Master's Certificate in Clinical Trial Management must be received from the Assistant Dean before the student starts any courses in the Advanced Certificate program.
How to Obtain the Certificate when all courses have been completed:
Submit the Notice of Completion to the RAQA Office (hard copy only) by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.