Office of Research Administration: Clinical Research Contracting

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Presentation transcript:

Office of Research Administration: Clinical Research Contracting Presented at: IRB Open House 5/19/2017 Presented by: Mont Brownlee/Hee Smith May 19, 2017

Two ORA Offices ORA at Pratt Street (formerly Fells Point) ORA at MRB Clinical Research Involving at least one Commercial Sponsor “Clinical Research” defined as: commercial clinical research that involves patients or PHI, or clinical testing or procedures, or drug/device diagnostic testing in humans or any planning/lab/clinical service in support of such clinical research ORA at MRB Everything else May 19, 2017

Types of Clinical Research Agreements Confidentiality Agreements (CDA or NDA) Clinical Trial Agreements (CTA) Funding, Supply or both Sponsor-initiated or Investigator-initiated Service Agreements (Lab services; Consulting) May 19, 2017

Study Startup Process: Parallel Processing Pre-Study Planning Prospective Reimbursement Analysis Budget Development Contracting Institutional Review Board (IRB) Study approved for startup Study Accounts Established May 19, 2017

THANKS! Any Questions? Mont Brownlee, III, J.D. ORA Director, Contracting Office of Research Administration Johns Hopkins School of Medicine 750 East Pratt St. 14th Floor Baltimore, Maryland 21202 Phone: 410-361-8355 Email: fbrownl1@jhmi.edu Hee Smith, J.D., M.S. Assistant Director Office of Research Administration Johns Hopkins School of Medicine 750 East Pratt St. 14th Floor Baltimore, Maryland 21202 Phone: 410-361-8353 Email: hsmith53@jhu.edu May 19, 2017