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Instructor Class Description

Time Schedule:

Annette L. Fitzpatrick
EPI 587
Seattle Campus

Practical Aspects of Research Operations

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.

Class description

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.

Recommended preparation

Completion of at least 1 graduate level course in Epidemiology and Biostatistics or general knowledge of epidemiological methods.

Class assignments and grading

Credit/no credit.

Class participation/discussion.

The information above is intended to be helpful in choosing courses. Because the instructor may further develop his/her plans for this course, its characteristics are subject to change without notice. In most cases, the official course syllabus will be distributed on the first day of class.
Course Website
Last Update by Angelica M. Buck
Date: 10/10/2012