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

2. 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

3. 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

4. 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

5. 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:
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:
May 19, 2017