Clinical Research Curriculum

This course is designed to familiarize one with the language and concepts of clinical investigation and statistical computing, as well as provide opportunities for problem-solving, and practical application of the information derived from the lectures. The material is organized along the internal logic of the research process, beginning with mechanisms of choosing a research question and moving into the information needed to design the protocol, implement it, analyze the findings, and draw and disseminate the conclusion(s). Prereq: M.D., R.N., Ph.D., D.D.S., health professionals.

Written communication is a critical skill in clinical science. We disseminate our work to others through publications, and we obtain the resources to conduct research through grant proposals. This course has been developed for Kl2 and CRSP scholars. The course focuses on writing grant proposals and, in particular, specific sections of an NIH-style grant. However, the principles discussed in the course apply to any type of proposal. Prereq: CRSP 401 or equivalent.

To move their work forward, investigators must be able to present their research effectively to both scientific and lay audiences. Although "the written word" is probably the first medium that comes to mind when we think of communication in scientific circles, other modes of communication are also vital. The main objective of this course is to help scholars improve their oral and poster presentation skills, as well as interaction with the mass media. This objective will be achieved through a combination of didactic sessions, readings, and presentations by the students. Prereq: CRSP 401 or equivalent.

Application of statistical techniques with particular emphasis on problems in the biomedical sciences. Basic probability theory, random variables, and distribution functions. Point and interval estimation, regression, and correlation. Problems whose solution involves using packaged statistical programs. First part of year-long sequence. Offered as ANAT 431, BIOL 431, CRSP 431, PQHS 431 and MPHP 431.

Methods of analysis of variance, regression and analysis of quantitative data. Emphasis on computer solution of problems drawn from the biomedical sciences. Design of experiments, power of tests, and adequacy of models. Offered as BIOL 432, PQHS 432, CRSP 432 and MPHP 432. Prereq: PQHS/EPBI 431 or equivalent.

This course is designed to introduce students to the ethical, policy, and legal issues raised by research involving human subjects. It is intended for law students, post-doctoral trainees in health-related disciplines and other students in relevant fields. Topics include (among others): regulation and monitoring of research; research in third-world nations; research with special populations; stem cell and genetic research; research to combat bioterrorism; scientific misconduct; conflicts of interest; commercialization and intellectual property; and the use of deception and placebos. Course will meet once per week for 2 hours throughout the semester. Grades will be given based on class participation and a series of group projects and individual short writing assignments. Offered as BETH 503, CRSP 603 and LAWS 5225.

The Capstone will provide hands-on experience in conducting clinical research. To complete the Capstone project the student will register for 3 credit hours and dedicate at least 160 hours over the course of a semester, typically 20 hours per week for 8 weeks. Under the guidance of a Capstone Advisor the student will develop a Capstone project or internship/practicum, which may take diverse forms: A study project; Internship/Practicum: A combination of tasks necessary for the successful implementation of a study, such as attending team meetings, developing an IRB protocol, designing study forms, assisting with recruitment, study procedures, data management/cleaning, descriptive analysis, secondary analysis; Another format, with approval of CRSP director and Capstone Advisor.

CRSP Thesis M.S.

This course provides an introduction to the principles of epidemiology covering the basic methods necessary for population and clinic-based research. Students will be introduced to epidemiologic study designs, measures of disease occurrence, measures of risk estimation, and casual inference (bias, confounding, and interaction) with application of these principles to specific fields of epidemiology. Classes will be a combination of lectures, discussion, and in-class exercises. It is intended for students who have a basic understanding of the principals of human disease and statistics. Offered as PQHS 490 and MPHP 490. Prereq or Coreq: PQHS/EPBI 431 or Requisites Not Met permission.