Program Overview

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.

Program Overview

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.

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.

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.
• 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.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS

Tuition & Fees

Tuition rates are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more.

Regulatory Affairs and Quality Assurance at the School of Pharmacy

For over five decades, Temple University's School of Pharmacy has provided outstanding graduate-level coursework in RA and QA. Regulatory affairs and quality assurance are the practices through which professionals ensure that products comply with government regulations and meet industry standards. The School of Pharmacy has:

• Pioneered RA and QA graduate education in 1968, offered the first RA and QA online degree program and offers the most comprehensive RA and QA curriculum.
• Outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught.
• Attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare).
• Schedules live courses with interactive discussions and workshops on evenings and weekends.
• Hundreds of students from across the country, facilitating great networking opportunities.
• Provides individualized services to students.