The Office of Management and Budget  (OMB) implemented their Uniform Guidance in 2014 which dictates the administrative, accounting, audit rules and principles for all federal awards; including federal pass-thru awards and multi-center clinical trials. Under Section 200.343 of the federal Uniform Guidance the federal government has required non-federal organizations to close out federal awards by 90 days after the end date.  In the past final billings beyond the… Continue Reading

By Jenny Kucera, IRB Administrator/Education Coordinator Several questions have come into the IRB Office during the last quarter. The information below addresses some of these questions, providing additional information on protocol changes using referenced protocols, how to change a Principal Investigator, and IRB approved registries/tissue banks. It’s important that the IRB application reflects the most current version of a protocol. To insure that the IRB… Continue Reading

by Deb Vetter, Director of Sponsored Programs Administration SPA’s practice to require principal investigators (PI) to devote measurable effort on sponsored projects may create problems when budgeting for clinical trials. SPA’s directive is to assign PI effort to each sponsored project, with the minimum being 1%. Clinical trials, on the other hand, may require only a small amount of PI effort. Often the PI’s effort… Continue Reading

Presented by Tara Scrogin, JD, Interim Chief Compliance Officer and Debra Bishop, Campus Compliance Specialist Breaking the Glass (BTG) is the term we use to describe the application pop-up in One Chart to alert users that they are accessing confidential patient information which is restricted to a “need to know” basis. All patient records are to be accessed only to perform essential job functions but… Continue Reading

UNeHealth has moved into offices in the College of Nursing, 5th floor. Look for the UNeHealth team; Tara Scrogin, Amy Carson, Augustine Osuala, and Karla Klaus in their new location, phone numbers remain the same. UNeHealth handles the following types of agreements: CDAs for industry-funded clinical trials CTAs for industry-funded clinical trials [Phase I-IV] Compassionate use Master CTAs for industry funded clinical trials [Phase I-IV]… Continue Reading