Learn more about the post-master's certificate in Clinical Trial Management.
About the Certificate
The post-master's certificate in Clinical Trial Management is designed for those who hold an MS in Regulatory Affairs and Quality Assurance and want to keep current with industry issues and meet regulatory requirements for training. The certificate program is also open to professionals with other master's or doctoral degrees.
The Clinical Trial Management certificate is specifically designed for pharmaceutical and healthcare professionals who actively contribute to the clinical trial process, including physicians, clinical research monitors, investigators and coordinators, and members of Institutional Review Boards (IRBs). Coursework 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. The certificate leads to understanding how clinical trials must be designed and overseen in the pharmaceutical industry, including writing protocols and consent forms, understanding the requirements of Good Clinical Practices, and managing budgets and data.
Time Limit for Certificate Completion: 4 years
Campus Location: Online and Fort Washington
Full-Time/Part-Time Status: The post-master's certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.
Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.
Admission Requirements and Deadlines
Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.
APPLY HERE to the post-master's certificate program.
Master's Degree in Discipline/Related Discipline: Applicants must hold a master's degree in a Pharmacy-related field, including but not limited to an MS in Regulatory Affairs and Quality Assurance. Graduates of Temple University's RAQA program take certificate coursework to keep current with industry issues and meet regulatory requirements for training. Applicants with an advanced science degree from an accredited institution of higher learning other than Temple University must have worked in the pharmaceutical industry for a minimum of three years.
Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a bachelor's degree from an accredited institution. While no specific major is required, most applicants should have a background in biological sciences, engineering, healthcare, natural sciences or related discipline.
Certificate Requirements
Number of Credits Required to Complete the Certificate: 12 for graduates of the Temple University Regulatory Affairs and Quality Assurance (RAQA) MS; 15 for students who completed their master's degree at an institution other than Temple University
Required Courses:1
| Code | Title | Credit Hours |
|---|---|---|
| Core Courses | ||
| QARA 5459 | Drug Development | 3 |
| QARA 5536 | Good Clinical Practices | 3 |
| QARA 5537 | Clinical Trial Management | 3 |
| QARA 5612 | Bioethics for Pharmaceutical Professionals | 3 |
| Elective | ||
| Select one from the following: 2 | 3 | |
| Fundamentals of Pharmacology and Pharmacokinetics | ||
| Quality Audit | ||
| Statistics for Clinical Trials | ||
| Clinical Drug Safety and Pharmacovigilance | ||
| Global Clinical Drug Development | ||
| Project Management for Clinical Trials | ||
| Post-Marketing Safety Surveillance | ||
| Pharmacoepidemiology | ||
| Benefit Risk Management and Safety Signaling of Healthcare Products | ||
| Clinical Data Management (CDM) | ||
| Total Credit Hours | 15 | |
- 1
Graduates of Temple University's RAQA MS program take four courses to complete 12 credits, provided none of the courses were completed previously as part of their RAQA master's degree. Students who earned a non-Temple master's degree must complete all four core courses and one elective for a total of 15 credits.
- 2
Students holding a Temple RAQA MS select from the list of electives to complete 12 credits for the post-master's certificate only if they previously completed one or more core courses in earning their master's degree. All students who earned a non-Temple master's degree must select one elective to complete a total of 15 credits.
GPA Required to be Awarded the Certificate: 3.0 minimum
Contacts
Certificate Program Web Address:
Department Information:
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728
267-468-8560
Mailing Address for Application Materials:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728