EDUCATION AND TRAINING OPPORTUNITIES FOR CLINICAL RESEARCH COORDINATORS.  The AHC will be offering a Certificate Program for training clinical research coordinators for University staff. To obtain the Certificate, all modules must be successfully completed. However, coordinators may enroll in individual modules depending upon their prior experience and education.
Module 1. Clinical Research: Introductory Seminar for Health Professionals (Course number 5550, offered Spring Semester 2003). This course, taught by Russell Luepker, M.D., M.S., Mayo Professor of Epidemiology, provides learning opportunities on the design and implementation of clinical research protocols. It is a 2-credit course, intended for nurses and other health professional staff working in or preparing to work in a clinical research setting. Faculty may also participate in this course. However, it does not replace the Masters Program in Clinical Research, which is the preferred education vehicle for clinical research for faculty. Contact Andrea Kish at kish@epi.umn.edu for detailed information on how to register, the cost of the course, etc. The syllabus can be viewed at www.epi.umn.edu/epi_pages/Syllabi/pdf_files/s02_5550.pdf. (This course is subject to cancellation if there are an insufficient number of registrants.)
Module 2. Practical Aspects of Clinical Research. A two-part seminar (8 hours total) focusing on Good Clinical Practice and providing an overview of protocol development, the consent process, and study documentation. Times, place and other details will be announced soon.
Module 3. Navigating the University Environment. A two-hour seminar with presentations from the Office of Regulatory Affairs, the Research Subjects Protection Program, and others. Details to be announced soon.
Module 4. Internships coordinated by the Research Services Organization. Designed to meet personal objectives, these will be individually arranged internships -- either a “Regulatory and Administrative Internship” (60 hours) or a “Clinical Coordinator Internship” (40 hours). More details to follow.
 

USING SIGNIFICANT RISK MEDICAL DEVICES IN CLINICAL TRIALS.  The FDA places investigational medical devices into one of two categories: significant risk and non-significant risk. A significant risk device is an investigational device that is any of the following: intended as an implant; used in supporting or sustaining life; of substantial importance in diagnosing, curing, mitigating, or treating disease; or otherwise presents a potential for serious risk. In order to use a significant risk investigational device in a clinical study, an Investigational Device Exemption Application (IDE) must be submitted to the FDA and obtain IRB approval. The non-significant risk device requires only IRB approval. Additional information about IDEs can be obtained at the IND/IDE Assistance Program website
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