The Starting Point

The institutional review and endorsement of clinical trial protocols to for-profit sponsors also requires a submission of a proposal to Sponsored Projects.  When participation in an Industry Sponsored Clinical Trial appears likely, submit to Sponsored Projects in Kuali Research the documents listed below. These documents are required to begin contract negotiation.

  • In Kuali Research, the clinical trial questions under the "Questions" tab, within the "Compliance" panel must be answered
  • Form 700-U Financial Disclosure for Principal Investigator and/or Co-Principal Investigator (original to be forwarded to Office of Research) (no longer required after 9/25/17- for more information, click here)
  • Draft Budget
  • Clinical Trial Protocol
  • Draft Clinical Trial Agreement (CTA) or Draft Contract, if provided by sponsor

While the contract or CTA negotiation process proceeds, the PI and study team should proceed with other required startup activities, including developing and negotiating the budget.

Investigators should notify their assigned Principal Contract Officer as soon as possible when initiating a clinical trial supported by a for-profit sponsor. The review of the proposal and negotiation of the clinical trial agreement requires time and cannot be left to the last minute.

Sponsored Projects can begin to negotiate a clinical trial agreement prior to IRB approval. However, the clinical trial cannot commence until the IRB approves the protocol and Sponsored Projects has signed the clinical trial agreement.

Helpful Tools

Clinical Trial Decision Tree

The clinical trial decision tree is a visual aid designed to help assess whether industry-funded studies qualify as clinical trials under the UC definition.

Investigator-Initiated Trials (IITs) Toolkit

IITs require special consideration in the planning stages. UC Braid's IITs toolkit provides guidance on starting up an IIT to facilitate efficient contracting and move the trial forward as quickly as possible.

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