Available at Pre- and Post-Master’s Levels

Pre-Master’s Certificate in Clinical Trial Management

This five-course 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:

• 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 Project Management for Clinical Trials (5547) or Clinical Data Management (5618) or Clinical Drug Safety and Pharmacovigilance (5538) or Risk Management and Safety Signaling of Healthcare Products (5578)

Students have four years to complete the Certificate in Clinical Trial Management and must mainatin an overall B average.

Brochure
Application Form
Notice of Completion

Post-Master’s Certificate in Clinical Trial Management

Students who have received the M.S. in RAQA 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 Clinical Trial Management. Students must apply for the certificate before starting the courses:

• 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 Clinical Data Management (5618) 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 M.S., they may petition to take one of the following electives as a substitute:

• Fundamentals of Pharmacology and Pharmacokinetics (5401)*
• Quality Audit (5494)*
• Clinical Trial Management (5537)
• Statistics for Clinical Trials (5497)
• Clinical Drug Safety and Pharmacovigilance (5538)
• Global Clinical Drug Development (5539)
• Project Management for Clinical Trials (5547)
• Post Marketing Safety Surveillance (5571)
• Pharmacoepidemiology (5573)
• Risk Management and Safety Signaling of Healthcare Products (5578)
• Regulatory and Legal Basis of Pharmacovigilance (5579)
• Clinical Aspects of Pharmaceutical Medicine I (5599)*
• Bioethics for Pharmaceutical Professionals (5612)
• Clnical Data Management (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 (5536)
• Bioethics for Pharmaceutical Professionals (5612)
• Clinical Trial Management (5536) or Global Clinical Drug Development (5539)
• Statistics for Clinical Trials (5497) or Clinical Drug Safety and Pharmacovigilance (5538) or Clinical Data Management (5618) or Project Management for Clinical Trials (5547) or Risk Management and Safety Signaling in Healthcare Products (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 the Assistant Dean, indicating the courses they wish to pursue.  Their program must be approved before the student registers for any courses. 

Brochure
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.