Education

At the beginning of the elective, each student will be assigned to a nurse coordinator and will be increasingly involved in working with that coordinator on the studies they are running. An opportunity will be given for the students to choose between various ongoing studies, but this must be done early since they must have passed the CITI training program and have IRB approval to participate in individual studies. Each student should be involved both with studies involving human subjects and those involving chart reviews. It would be anticipated that the students would receive authorship on any publication resulting from studies on which they are involved, provided that their participation is meaningful. Early in the elective, there will be an emphasis on didactic material beginning with discussions about the regulations and ethical considerations related to research in humans, the background for these and the role played by the IRB and an Office of Research Integrity. This will be followed by sessions on how to develop the proposal for a research project from conception of the idea through formulation of a hypothesis and specific aims, compiling the background, constructing the appropriate methods and analysis of results and, finally, a discussion of the potential significance. It will be expected that each student will develop a proposal/protocol during the elective with an ongoing active critique process.

Students will be involved in all aspects of preparation for and execution of prospective human studies and retrospective chart reviews. The didactic training deals with the regulations and ethical considerations related to research in humans, the process of obtaining approval for a study and the requirements associated with conducting a study.

 

Research Design and Statistics (9 SCH)
HPPH 7321 Research Design & Statistics
HPPH 7322 Intermediate Statistical Methods
HPPH 7323 Selected Topics in Statistics

 

 

Translational and Clinical Research; Purpose of the Course: Enable faculty to develop successful, fundable projects at TTUHSC SOM. NIH has shifted its focus on individualized research to a more collaborative approach targeting; bench to bedside; research or translational research where findings in the lab can be moved to clinics. As such, a certain amount of retooling in is in order for the traditional basic and clinical scientist. The TTUHSC SOM will present a course targeted at helping all faculty who are interested in either initiating or reviving their research activity. The course will focus on identifying a research question, developing a testable hypothesis and then preparing an individual research proposal (the product of the course).

Clinical Research Coordinator Training
Individuals will have a general overview and history of clinical research. Topics covered during the course are as follows: Basic Definitions, Phases Study Design; Regulatory bodies, Regulations; ICH-GCP; Study team responsibilities; Contract Budget Negotiation; Clinical Research Accounting; Study Conduct from SQV to Closure; and Common Mistakes; Audits.