Post-Master’s Certificate in Clinical Trial Management

This certificate program is designed for pharmaceutical and healthcare professionals who are interested in participating or already participate in all aspects of clinical trials. It provides the tools and information needed to design, conduct and audit clinical trials of pharmaceuticals. The courses emphasize protocol development, volunteer informed consent, study management, and the role and responsibilities of Institutional Review Boards. Required courses include:

Students who have received the M.S. in QA/RA are eligible to complete the Post-Master’s Certificate in Clinical Trial Management. Courses taken for the completion of the M.S. degree will not be counted towards the Post-Master’s Clinical Trial Management Certificate. Students need to take four required courses beyond the M.S. to receive the additional certificate in CTM. Students must apply for the certificate before starting the courses:

• Good Clinical Practices (Pharmaceutics 5536)
• Clinical Trial Management (Pharmaceutics 5537) or Global Clinical Drug Development (Pharmaceutics 5539)
• Bioethics for Pharmaceutical Professionals (Pharmaceutics 5612)
• Statistics for Clinical Trials (Pharmaceutics 5497) or Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538) or Clinical Data Management (Pharmaceutics 5618) or Project Management for Clinical Trials (Pharmaceutics 5547) or Risk Management and Safety Signaling in Healthcare Products (Pharmaceutics 5578)

If students have already taken one or more of the above listed courses as part of their M.S., they may petition to take one of the following electives as a substitute:

• Fundamentals of Pharmacology and Pharmacokinetics (Pharmaceutics 5401)*
• Quality Audit (Pharmaceutics 5494)*
• Clinical Trial Management (Pharmaceutics 5537)
• Statistics for Clinical Trials (Pharmaceutics 5497)
• Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538)
• Global Clinical Drug Development (Pharmaceutics 5539)
• Project Management for Clinical Trials (Pharmaceutics 5547)
• Post Marketing Safety Surveillance (Pharmaceutics 5571)
• Pharmacoepidemiology (Pharmaceutics 5573)
• Risk Management and Safety Signaling of Healthcare Products (Pharmaceutics 5578)
• Regulatory and Legal Basis of Pharmacovigilance (Pharmaceutics 5579)
• Clinical Aspects of Pharmaceutical Medicine I (Pharmaceutics 5599)*
• Clinical Aspects of Pharmaceutical Medicine II (Pharmaceutics 5602)*
• Bioethics for Pharmaceutical Professionals (Pharmaceutics 5612)
• Clnical Data Management (Pharmaceutics 5618)

Students with PhD or MS degrees from other schools may petition the School of Pharmacy to allow them to complete a Post-Master's Certificate in Clinical Trial Management.  They will be required to complete five courses:

• Good Clinical Practices (Pharmaceutics 5536)
• Bioethics for Pharmaceutical Professionals (Pharmaceutics 5612)
• Clinical Trial Management (Pharmaceutics 5536) or Global Clinical Drug Development (Pharmaceutics 5539)
• Statistics for Clinical Trials (Pharmaceutics 5497) or Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538) or Clinical Data Management (Pharmaceutis 5618) or Project Management for Clinical Trials (Pharmaceutics 5547) or Risk Management and Safety Signaling in Healthcare Products (Pharmaceutics 5578). 

If they have taken similar courses in another graduate-level program, they may petition to take alternate electives.

To be eligible, they must write a letter to Assistant Dean Wendy Lebing, indicating the courses they wish to pursue.  Their program must be approved before the student registers for any courses. 

Application
Post-M.S. Notice of Completion

*These courses only count toward the Certificate in Clinical Trial Management (Post-Master’s) if the student already has an M.S. in QA/RA.