Basic elements of a research proposal and implementation will be covered. Topics include regulatory approvals; continuing regulatory oversight; monitoring patient safety; recruitment; clinical assessments; laboratory assessments; provision of treatment; on-going quality control of assessments, data, treatment, data collection, entry and auditing; provision of experimental tests/tasks; data analyses; publication planning. The overall objective of this course is to acquire a working knowledge of how to implement a clinical research proposal. The specific objectives are as follows:
- To acquire a working knowledge of how to integrate research resources to successfully conduct a clinical research project.
- To acquire a working knowledge of regulatory aspects of human research necessary to launch and complete a clinical research project.
- To learn the procedures involved in investigational new drug and device applications.
- To acquire a working knowledge for collection, quality control and analysis of research data.
- To acquire a working knowledge of effective presentation and writing skills needed for research publications.
Prerequisites: None
Credit: 1 hour; required for all program students
Grading Criteria: Pass/Fail based on final examination and attendance (attendance at 80% of class sessions is required)
Semester Offered: Fall
Course Director: Robert D. Toto, MD, Professor, Dept. of Internal Medicine, Division of Nephrology,
phone: 214 648-3482, fax: 214 648-2071
Course Administrator: Mack Dressler, Dept. of Clinical Sciences,
phone: 214 648-6498, fax: 214 648-3934 fax
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