Clinical Research: From Proposal to Implementation (DCS 5115)

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; ongoing quality control of assessments, data, treatment, data collection, entry, and auditing; provision of experimental tests/tasks; data analyses; and 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:

  1. To acquire a working knowledge of how to integrate research resources to successfully conduct a clinical research project
  2. To acquire a working knowledge of regulatory aspects of human research necessary to launch and complete a clinical research project
  3. To learn the procedures involved in investigational new drug and device applications
  4. To acquire a working knowledge for collection, quality control, and analysis of research data
  5. 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