Live On-Campus Graduate Certificate Program
Getting Started: Students may apply at any time. Requirements for the program include an undergraduate degree from an accredited institution and a completed application form.
Students in this program will be taking courses on the medical campus with the masters degree students. The certificate program consists of four courses that explore:
GMS CI 675 Designing Clinical Research Studies – Fall Semester
This course covers important epidemiologic principles necessary for designing clinical research studies. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, sample size determination, and statistical analysis issues. Students will design and present a clinical research study during the course.
GMS CI 640 Regulatory and Compliance Issues – Fall Semester
This course explains the regulatory requirements for healthcare products, that is, drugs, biologics, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provided is an in-depth review of the pertinent FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a product from research to market.
Content and preparation of regulatory submissions, including an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K PreMarket Notification are described. International requirements for health care products are also reviewed.
Aulwes. Fall, 4cr.
GMS CI 790 Seminar in Clinical Investigation – Spring Semester
**Prereq: GMS CI 675 Designing Clinical Research Studies
The goal of this course is to provide students experience in reading and evaluating current l literature that may be pertinent to the origination, design, implementation and evaluation of clinical research. The course is conducted in a seminar format.
Each week, students read and critically analyze assigned readings of recent literature which may be relevant to clinical research about human diseases. Teams of students then read the discussion in seminar and the entire class participates. This format provides an opportunity to learn to critically evaluate the scientific literature and to develop oral presentation skills.
Fish, Hess Pino, Spring, 2 cr.
GMS CI 660 Good Clinical Practices in Clinical Research – Summer II
Prereq: GMS CI 675 Designing Clinical Research Studies
Introduces regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed on GCP compliance fro m an industrial perspective. Topics include: selecting qualified investigators; obtaining ethical approval for patients, and initiating sites successfully. Group discussions and guest speakers help students learn practical skills.
Malikova. Summer, 4 cr.
Students have the potential to complete the program in one academic year including Summer Session II if they opt to take two courses in the Fall, one in the Spring, and one in Summer. Students may also opt to take just one course per semester.
Tuition & Fees
The On-Campus Graduate Certificate program in Clinical Investigation is a non-Degree program. This is an important distinction because financial aid is not available to students in non-Degree programs. Find information about the cost per credit here.
Questions?? If you have any questions about the On-Campus Graduate Certificate program, please contact the Program Director, Stacey Hess Pino at firstname.lastname@example.org.