Training for Clinical Research Coordinators and Faculty

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). 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 http://www.epi.umn.edu/academic/pdf/s05_5550.pdf. (This course is subject to cancellation if there are an insufficient number of registrants.)

Module 2 . Practical Aspects of Clinical Research – November 7, 9, 10 & 14, 2005  3:00 p.m. – 5:00 p.m.  Topics will include:

* Overview of Research Regulations and Good Clinical Practice Guidelines Roles and Responsibilities of Investigators and Sponsors

* The Clinical Trial Protocol and Investigator's Brochure

* The Consent Form and Consent Process

* Essential Documents for the Conduct of a Clinical Trial

* Adverse Event Reporting

* From New Protocol to Final Approval: Getting a Clinical Trial through the System

* The Research Services Organization

Module 3. Navigating the University Environment – November 16 & 17, 2005  3:00 p.m. – 5:00 p.m. Presentations from the following groups will be given - and groups with application processes will discuss their forms/process:

* Office of Regulatory Affairs

* Institutional Review Board

* Environmental Health and Safety (including Institutional Biosafety Committee and Radiation Protection)

* Office of the General Counsel (Academic Misconduct)

* Sponsored Projects Administration

* Fairview Research Administration

* Investigational Drug Services

* Investigational New Drug/Investigational Device Exemption Assistance Office

* General Clinical Research Center

* Cancer Protocol Review Committee

* Protocol Review and Data Use Committee

* Research Services organization

Modules 2 and 3 are offered, free of charge, to all University and University of Minnesota Physicians employees. A fee of $150 will be charged for all others. 

To register for Modules 2 and/or 3, send your name, contact information, and module numbers you plan to attend to rso@umn.edu. Registrations must be received by Oct. 14, 2005 - firm.