Presented by Gail Paulsen, IRB Administrator during the March Clinical Research Coordinator’s Quarterly Updates. UNMC Human Research Protection Program (HRPP) Policy 5.1 describes the Organization’s requirements for the process and documentation of informed consent. Legally effective informed consent must be obtained for all subjects or legally authorized representatives (LARs) prior to their participation in a study. Informed consent must be documented on IRB-approved consent forms and… Continue Reading

Presented by Tim Widman, Clinical Outreach Coordinator, Clinical Research Center during the March Clinical Research Coordinator’s Quarterly Updates. There are a number of recruitment tools and strategies available to research coordinators to improve subject recruitment for clinical trials. Basic recruitment strategies are easily accessible, inexpensive or free, and IRB approved templates are often available. The simplest may be a study flyer or brochure which can… Continue Reading

Presented by Christopher Kratochvil, Associate Vice Chancellor for Clinical Research, Vice Presi-dent for Research Nebraska Medicine during the March 2016 Clinical Research Coordinator’s Quarterly Update. We’re looking to gather information regarding your experiences with using a central IRB. Whether your experience is with Chesapeake, the NIH, PCORI, NCI, or another central IRB we’re interested in what works, what doesn’t, and sponsor perceptions. One of the… Continue Reading

Presented by Christopher Kratochvil, MD, Associate Vice Chancellor for Clinical Research, Vice President for Research Nebraska Medicine during the March 2016 Clinical Research Coordinators Quarterly Update. An institutional goal was set to increase clinical trial enrollment by 10% during fiscal year 2016. Not only is this desirable for our patients but increasing clini-cal trial enrollment is a requirement to achieve Comprehensive Cancer Center status, the… Continue Reading

by Courtney Kennedy, Clinical Research Advisor With direction and approval from research leadership, the notification that an enrolled study participant has been admitted to our campus is being re-instated in March 2016. This tool is being implemented to assist with timely adverse event reporting as required by FDA regulations. When live, an alert will appear in both the Principal Investigator’s and Coordinator’s In Basket when… Continue Reading