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 the MS in Epidemiology and Preventive Medicine and develop short courses (e.g. PREV 616 Introduction to Clinical Research) and seminars ( PREV 633 Legal and Regulatory Issues in Clinical Research) which provide training in clinical research skills that were not already available through the Program in Epidemiology and Human Genetics.  Recently the K30 award has also supported the development of a Health Economics Course.  In addition, the K30 grant has allowed us to "reformat" our courses to make the curriculum more flexible (e.g. PREV 706 as a 5 days short course).  Despite these achievements, many faculty and fellows who are potential "K30 scholars" are not able to take the entire MS in Clinical Research track.  Nevertheless, they 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 a combination of coursework (11 credits) to provide training in the core 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 11 credit certificate in clinical research program will provide training in the core competencies in clinical research including study design, biostatistics, data management, scientific communication and the ethical, legal and regulatory issues in clinical research.

List of courses:

• PREV600 (3 credits) Principles of Epidemiology
• PREV620 (3 credits) Principles of Biostatistics
• PREV616 (2 credits) Introduction to Clinical Research at UMB
• PREV706 (2 credits) Research Informatics: Data Management for Research
• PREV633 (1 credit)   Application of Legal and Regulatory Issues in Clinical Research

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 DEPM 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 and Preventive Medicine. 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 available at (http://www.graduate.umaryland.edu/admissions/req_application.html). 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.