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 Coeus the documents listed below. These documents are required to begin contract negotiation.
- In Kuali Coeus, the clinical trial questions under the "Questions" tab, within the "Compliance" panel must be answered
- Request for Exception to Principal Investigator Eligibility, if required
- Form 700-U Financial Disclosure for Principal Investigator and/or Co-Principal Investigator (original to be forwarded to Office of Research)
- 700-U Addendum (if required)
- 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 negotating 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.