Conducting Clinical Trials

Event Details

Tuesday, October 21, 2014
Medstar Georgetown University Hospital
Martin Marietta Conference Room
8:00 a.m. – 12:00 p.m.

register here

Clinical trials provide clinical investigators with the opportunity to bring cutting edge therapies and devices to their patients and to participate in academic medical research in a very meaningful way. Contract and budget negotiations with industry sponsors, compliance issues, publication and data rights, confidentiality and intellectual property are some of the elements of clinical trials that can make them challenging for all parties involved. Clinical research conducted at Medstar Georgetown University Hospital is under the purview of Georgetown University Medical Center.

The GUMC Office of Sponsored Research and Clinical Trials Office, in consultation with the Office of Regulatory Affairs, Office of Technology Commercialization, and Office of General Counsel, are responsible for negotiation of clinical trial agreements and compliance oversight. We invite clinical investigators and staff to attend this half day workshop on administrative and legal aspects of clinical trial setup, conduct and closeout at GUMC.

Agenda

8:00 – 8:30: Overview of CTA Negotiation and Setup
Doreen Robinson, PhD, GUMC Senior Associate VP for Sponsored Research

8:30 – 9:00: CTA Budget Negotiation and Billing Procedures
Tony Hursey, MPH, Director GUMC Clinical Trials Office (CTO)

9:00 – 9:30: Intellectual Property, Publication and Data Rights
Sharon Prisco, JD, Associate Director for Licensing and IP, GU Office of Technology Commercialization (OTC)

9:30 – 9:45: Break

9:45 – 10:15: Legal Issues in Clinical Trial Agreements
Kelly Blevins, JD, GU Associate General Counsel

10:15 – 10:45: IRB, Conflict of Interest and Other CTA-Related Regulatory Issues
Sheila Zimmet, JD, GUMC Senior Associate VP for Regulatory Affairs

10:45 – 11:45: Key Issues in Clinical Trial Setup, Management and Closeout
Sharon Levy, RN, BSN, Administrative Director, LCCC Clinical Research Management Office (CRMO)
Fannie Dela Cruz, CRA, Senior Administrative Director, GHUCCTS Clinical Research Unit (CRU)
Jenny Turnure, CRA, Director of Finance and Administration, Clinical and Centers, BGRO Clinical Departments

11:45 – 12:00: Questions and Wrap-up