Clinical Trial Management Certificate

The Clinical Trial Management Certificate in the at 51¶¯Âþ 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).ÌýThis certificate is part of the School of Pharmacy’sÌý.Ìý

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)Ìýand the clinical investigator.ÌýÌý

The Clinical Trial Management Certificate enables students to sharpen their knowledge of clinical trials in a graduate program setting without committing to the entire master’s degree. It provides the tools and information to understand how clinical trials must be designed and overseen in the pharmaceutical industry, including writing protocols and consent forms, delving into the requirements of good clinical practices, and managing budgets and data.Ìý

More than 60 courses are offered online in real time. The Clinical Trial Management Certificate may be pursued entirely online. Candidates must complete the required courses and application procedures to receive the certificate.

Regulatory Affairs and Quality Assurance at the School of PharmacyÌý

For over five decades, 51¶¯Âþ’s has provided outstanding graduate-level coursework in . 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 Ìý

  • 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;ÌýÌýÌý

  • has outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught;Ìý

  • attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare);Ìý

  • schedules live courses with interactive discussions and workshops on evenings and weekends;Ìý

  • has hundreds of students from across the country, facilitating great networking opportunities; andÌý

  • provides individualized services to students.  ÌýÌý

CertificatesÌýprovideÌýcredentials from 51¶¯Âþ’s well-respected RA and QAÌýgraduate program,Ìýwhich canÌýbe applied to the RA and QA master’s degree.Ìý

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.ÌýÌý

  • Drug Development (5459)Ìý

  • Good Clinical Practices (5536)ÌýÌý

  • Clinical Trial Management (5537) or Global Clinical Drug Development (5539)Ìý

  • 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)Ìý

All courses must be completed from 51¶¯Âþ’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 51¶¯Âþ’s Clinical Trial Management Certificate in its place. The request to waive a 51¶¯Âþ course must be submitted and approved by the assistant dean of RA and QA before starting the program.Ìý

Students interested in pursuing the RA and QA MS program may apply all credits earned from the Clinical Trial Management Certificate towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by 51¶¯Âþ’s graduate school.

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  • To be considered for the Clinical Trial Management Certificate, candidates must have a bachelor’s degree from an accredited institution of higher learning.Ìý

  • Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion).Ìý

  • Only one certificate may be completed before students receive the MS. Students must complete the Clinical Trial Management Certificate within four years.Ìý

  • Students must apply for the certificate within one year of completing all required coursework for the program.

Learn more about the application process.

Related Graduate Degrees

Tuition & Fees

In keeping with 51¶¯Âþ’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates at 51¶¯Âþ 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.

You can view the full on the Student Financial Services website. You can also view the .Ìý

Accreditation

51¶¯Âþ’s departments and programs are accredited by theÌý.

PH-CTM-GRAD

Additional Program Information

Available online.

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