Clinical research involves the testing and determining the safety and efficacy of new unapproved products, including pharmaceuticals, devices, and biologics in human subjects. Clinical trials in humans (volunteers and patients) are required before marketing approval by regulatory authorities such as the U.S. Food and Drug Administration (FDA). The law that governs clinical research is spelled out in Chapter 21 of the Code of Federal Regulations (CFR). In addition to requiring and legislating clinical trials, regulatory authorities define the standards by which clinical trials are to be conducted. These standards are known as Good Clinical Practices (GCPs).
In-depth knowledge of the CFR and GCP guidelines as well as international guidelines specifically as they relate to protection of human rights, prevention and detection of fraud, and the use of sound scientific principles, is a fundamental requirement for clinical research professionals. These individuals are key personnel involved in the conduct of clinical trials which, in turn, are pivotal in getting new products approved and on the market.
The master’s program in Clinical Research Management provides a strong foundation upon which to build or advance a career. The rigorous curriculum focuses on providing students a broad-based view of the biomedical sciences, as well as in-depth knowledge of regulatory requirements (CFR, GCP), ethical issues, and both the medical writing and administrative skills necessary to conduct clinical research. As part of the program, all students will complete an internship practicum in clinical studies and use this experience to write the internship practicum report pursuant to receiving the Master of Science (MS) degree. The average time to complete the degree is eighteen months with full-time enrollment.
About the School
The Texas College of Osteopathic Medicine accepted its first students in 1970. In 1975, TCOM came under the umbrella of North Texas State University, which later evolved into the UNT System that now i ... Read More