UCOP recently revised their Contract and Grant proposal and award reporting requirements. As a result, we’ve received guidance that for industry sponsored clinical trials, the Contract Research Organization (CRO) should be recorded as the “Sponsor” when the CRO is a party to the Clinical Trial Agreement (CTA) and the company should be recorded as the “Prime Sponsor”. For example, Pfizer may contract with ICON, Clinical Research Inc., a CRO, to negotiate and execute the CTA for a particular clinical trial. In this case, the CRO, ICON Clinical Research Inc., should be recorded as the “Sponsor” and Pfizer as the “Prime Sponsor”. For departments submitting proposals via Kuali Coeus, “Clinical Trial” should be selected for the “Activity Type” when utilizing these procedures.
As a reminder, the Principal Investigator’s Statement of Economic Interests, Form 700 U, will need to be completed for both the Sponsor and the Prime Sponsor. Original signed forms should be forwarded to the Office of Research during proposal submission.
Please be mindful of this new guidance as you enter proposal information into Kuali Coeus. Thank you in advance for your cooperation.
Should you have any questions, please direct your inquiries to the Principal Contract and Grant Officer assigned to your unit.