Annette L. Fitzpatrick
Provides the basics necessary to plan, implement, and manage a research study. Topics include human subjects applications, data collection, hiring and training of staff, participant recruitment and retention, data management, quality assurance and control, results reporting, communications, and budgeting. Prerequisite: K12 Clinical Scholar or one course in EPI/BIOST. Credit/no-credit only. Offered: A, even years.
While knowledge of study design and statistical analysis skills is critical in medical research, there are many other issues that a researcher must address to successfully complete a project. This seminar-style course is offered to provide the pragmatic aspects of doing clinical research, primarily covering the day-to-day operations of conducting a study. The course will cover all of the basics necessary to plan, implement, and manage a research study. Topics include human subjects and Institutional Review Board application, data collection methods, hiring and training of staff, participant recruitment, follow-up and retention, data management, quality assurance and control, results reporting, study monitoring, communications, and budgeting. The course will consist of 7 two-hour seminar style lectures with some computer instruction included. (NOTE: Two Mondays during Winter Quarter are holidays). The final session will consist of student presentations of their own research focusing on topics covered in class. Lectures are conducted by a research faculty member currently immersed in epidemiologic multidisciplinary and collaborative studies supplemented with guest lecturers from other departments in the University.
Student learning goals
Compare the different levels/categories of human subjects approvals and determine which is most appropriate for one’s own project(s as well as develop content for an informed consent;
Outline the necessary components of a study protocol; Implement quality assurance and quality control procedures into a study protocol;
Identify sources for acquiring data collection instruments pertaining to specific types of studies; Apply basic rules of questionnaire development, reliability and validity to one’s own project(s). Design questionnaires to maximize database and entry requirements;
Develop eligibility requirements, recruitment approaches, retention strategies, and appropriate incentives for successful clinical research studies.
Define and compute specific analytic variables to facilitate analysis of data; Integrate principles of database design and data management into one’s own project; Design reports and procedures to effectively monitor your project and address potential problems as they arise.
Construct a budget to include items across all stages of a project and provide justification for conduct of the study.
General method of instruction
Seminar-lecture with discussion.
Completion of at least 1 graduate level course in Epidemiology and Biostatistics or general knowledge of epidemiological methods.
Class assignments and grading