Clinical&Translational Science: Design Clin&Translational Res

Seminar emphasizing the skills for designing and executing clinical and translational research.

Synchronous online; Instructor permission required Open to degree and PACE students

CTS 6010 is intended for beginning investigators who want to learn how to design clinical and translational research. The course is taught online in a live, small group seminar-based format. Students will take turns presenting materials to the group and leading the discussion. There will be assigned readings and homework. Each student will prepare a full research protocol. The topic of research will be selected by the student. The protocol format will be consistent with the Research Strategy section of a National Institutes of Health (NIH) Small Research Grant (R03) or equivalent program. Course objectives include learning how to discuss, review, and design research. Successful completers of this course will know how to evaluate the strengths and weaknesses of research designs common to clinical and translational research, critically evaluate research protocols, and write a rigorous, original research protocol, including posing an important research question, choosing an appropriate research design, identifying appropriate subjects, designing measurements and developing plans to collect and analyze data, estimating sample size requirements, and preparing a project timeline.

This course combines lecture, discussion, and writing formats. Students should expect to spend 3 hours per week in class and 6-8 hours per week on coursework outside of class. Students are expected to attend class, read all assigned materials before they are discussed, prepare their final protocols, and participate in class discussions. Every session, the class will read one or more chapters from the textbook and prepare a portion of their research protocol. Students should be prepared to present their work to the class for discussion and critique. The class will meet in a special session (called a student study section) to review all the protocols. Each protocol will be reviewed by a primary and secondary reviewer as is commonly done by National Institutes of Health (NIH) study sections and other granting agencies. Each student will have the opportunity to serve as a primary and secondary reviewer. The reviewers will present the student's protocol to the rest of the class who will discuss the pros and cons and come to a decision about scientific merit. The student (Principal Investigator) will be present during this discussion but will not be allowed to participate until after the study section has completed the discussion. The course is at the graduate level and non-participation is incompatible with receiving full benefit of the class. The same course requirements are expected of all students, regardless of whether a student is receiving course credit or auditing.

Grades will be based on attendance and participation, weekly assignments, a midterm, and a final research protocol.