Clinical Trials

A clinical trial is a research study designed to examine the safety and effectiveness of a specific drug, device, or treatment. Clinical trials are extensively regulated by the Food and Drug Administration (FDA,) the Department of Health and Human Services (DHHS) and the Institutional Review Board (IRB). The below links provide access to critical information and elements necessary to start the clinical trial process. Any incomplete or incorrect clinical trial packages submitted to the Institutional Review Board (IRB) and the Office of Sponsored Research (OSR) will be returned to the PI, delaying the approval and start of the project.

If a project is terminated early, OSR will attempt to recover reasonable start-up costs in addition to earned expenses. PIs should discuss the need for non-refundable start-up costs in their initial interactions with sponsors such that this condition is more easily incorporated into the final contract.

Resource/Topic	Description
Institutional Review Board (IRB) Review and Approval	Federal law and NU policy mandate prior written and dated IRB approval of all research involving human subjects regardless of the funding source
Clinical Trials and Clinical Trials Materials	Components of a complete clinical trial package
Object Codes Note: Scroll down to "Financial Account" header	Object codes and Office of Sponsored Research (OSR) forms for industry sponsored clinical trials accounts
Northwestern University Clinical and Translational Sciences Institue (NUCATS)	The burgeoning clinical and translational research enterprise at Northwestern University is being spearheaded by the new Northwestern University Clinical and Translational Sciences Institute (NUCATS) and now includes services formerly offered through the Northwestern Center for Clinical Research (NCCR).  The role of NUCATS is to facilitate growth of translational and clinical research across the entire NU enterprise.  The Institute will continue to offer a wide range of clinical research support services to Northwestern University and the Chicagoland area.
PI-Initiated Studies Note: Scroll down to "PI Initiated Studies" header	Responsibility of PI to notify Office of Sponsored Research (OSR) of PI-initiated studies
Non-Refundable Start-Up Costs Scroll down to "Non-Refundable Start-Up Costs" header	Information regarding recovery of non-refundable start-up costs
Food and Drug Administration (FDA) Regulations	Food and Drug Administration (FDA) regulations governing clinical trials
Office for Human Research Protections (OHRP)	Federal policy for the protection of human subjects