Certificate Program in Clinical Research
Rationale for the Program
Physicians and other health professionals who wish to work in clinical research often need additional didactic training in order to gain the necessary skills that are not covered in their health professional education. The Clinical Research Curriculum Award or K30 grant has allowed us to create the MS in Clinical Research track in Program in Epidemiology and Human Genetics offered by the Graduate Program in Life Sciences. The K30 program has developed short courses (e.g. PREV 616 Introduction to Clinical and Translational Research) and seminars (PREV 633 Legal and Regulatory Issues in Clinical Research) which provide training in clinical research skills that were not previously available to UM students. In addition, the K30 award has supported the development of a Health Economics Course as well as the "reformatting" of courses to make the curriculum more flexible (e.g. PREV 706 as a 4 day short course). Despite the flexibility of the pgoram, many faculty and fellows who are potential "K30 scholars" are not able to take the entire MS in Clinical Research track but would like evidence that they have successfully completed limited training in clinical research. The goal of this certificate program is to provide this option.
Educational objectives of the Program
To provide didactic training (12 credits of coursework) in the core aspects of clinical research.
- Design and conduct a study that minimizes bias and confounding.
- Design studies that can be applied to clinical practice.
- Access and critically appraise research literature in medicine and related domains.
- Form research question, operationalize variables.
- Know when and how to use quantitative methods and understand the results.
- Choose the appropriate sample size and power to test hypotheses.
- Effectively collect and maintain study data.
- Evaluate and communicate study findings to scientific and lay audiences.
- Write a research grant proposal that will successfully compete for funding.
- Manage a research team and build multidisciplinary collaborations.
- Respect and protect the rights and welfare of individuals participating in research.
Description of the program
This 12 credit certificate in clinical research program will provide training in the core competencies of clinical research including study design, biostatistics, data management, scientific communication and the ethical, legal and regulatory issues in clinical research.
List of courses
- PREV 600 (3 credits) Principles of Epidemiology
- PREV 620 (3 credits) Principles of Biostatistics
- PREV 616 (2 credits) Introduction to Clinical and Translational Research at UMB
- PREV 706 (2 credits) Research Informatics: Data Management for Research
- PREV 633 (1 credit) Application of Legal and Regulatory Issues in Clinical Research
- CIPP 907 (1 credit) Research Ethics
Expected student learning outcomes
Students are expected to obtain a B or higher in all courses to demonstrate competency in the above areas at the level of a certificate program.
Faculty resources
The program will be supported through the K30 program, the clinical research curriculum award. The course work is already in place for this program. Advising will be done through faculty supported by the K30 program. The tracking of certificate completion will be done jointly by the Department of Epidemiology & Public Health Academic Office and the K30 Program staff.
Application
Those applicants who are already in another program in the Graduate School do not need to apply again to the GS; however, an application should be sent to the Academic Office of the Department of Epidemiology & Public Health. Applicants who are not in another program in the Graduate School need to apply for admission as a coursework-only student. They must hold a bachelor's degree from a regionally-accredited institution with a B or 3.0 grade point average or hold equivalent education and training from a foreign college or university. International applicants in the United States whose immigration status permits them to enroll on a non-degree basis must meet the language proficiency requirements of the Graduate School, i.e., the TOEFL or the IELTS. Students must complete an Application for Non-Degree Admission accompanied by unofficial transcripts and a professional vitae/resume and a statement of goals (Annotated Statement of Goals form) which lists the Certificate in Clinical Research Courses and their rationale for taking them (Annotated Application for Certificate in Clinical Research). Forms are available at Graduate School website. If GRE or MCAT scores are available, please include them. Students applying for non-degree status must also obtain approval to enroll from the graduate program offering the applicant’s desired course(s).
Coursework only applications must be submitted more than two weeks before the start of the semester in which courses will be taken.
Financial Aid
Financial assistance is not available for the certificate program.