1 / 5

University of Pittsburgh Clinical and Translational Science Institute CTSI Regulatory Knowledge and Support

Regulatory Oversight. University of Pittsburgh Research Conduct andCompliance OfficeInstitutional Review Board (IRB)Institutional Animal Care and Use Committee (IACUC)Institutional Biosafety (rDNA) OfficeConflict of Interest OfficeEducation and Compliance for Human Subject ResearchEducation and Compliance for Animal ResearchRadiation Safety CommitteeEmbryonic Stem Cell Research Oversight Committee (ESCRO).

jara
Download Presentation

University of Pittsburgh Clinical and Translational Science Institute CTSI Regulatory Knowledge and Support

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

    1. University of Pittsburgh Clinical and Translational Science Institute (CTSI) Regulatory Knowledge and Support Core Director: Laurel Yasko, BSN, RN, CCRC

    2. Regulatory Oversight University of Pittsburgh Research Conduct and Compliance Office Institutional Review Board (IRB) Institutional Animal Care and Use Committee (IACUC) Institutional Biosafety (rDNA) Office Conflict of Interest Office Education and Compliance for Human Subject Research Education and Compliance for Animal Research Radiation Safety Committee Embryonic Stem Cell Research Oversight Committee (ESCRO)

    3. University of Pittsburgh/UPMC Research University of Pittsburgh IRB reviews for 2007 (6,280) Full Board � 1,830 (10 committees) Expedited � 3,429 Exempt � 1,021 UPMC Clinical Trials Office (Industry-sponsored studies- opened October 2004) 504 studies to date

    4. RKSC Goals Establish a CTSI Regulatory Knowledge and Support Core (RKSC) for three distinct groups of stakeholders and provide resources, services, training, and education that meet the unique needs of each group of stakeholders Research Community (clinical and translational investigators, research coordinators, dedicated research staff, basic scientists embarking on clinical research activities) Lay Community (actual and potential research participants drawn from the in- and out-patient settings of the University of Pittsburgh Medical Center, and from the general population of Pittsburgh and the surrounding tri-state area) Health Professional Community (individuals working within clinical and hospital settings � including physicians, nurses, therapists, technicians, dentists, pharmacists, and other health professionals � whose primary responsibility is to provide clinical care to patients)

    5. Examples of Services Support and assistance with regulatory aspects of clinical and translational research. Institutional Data and Safety Monitoring Board Research Participant Advocacy IND/IDE Support

    6. Examples of Education Research Coordinator Orientation Program OHRP Conference Individual training Health Professional Education Research participants

More Related