Industry Sponsored Clinical Trials- Required Proposal Documents

Dear Colleagues,

In recent months, Sponsored Projects received many inquiries regarding the proposal submission requirements for Industry Sponsored Clinical Trials.   This message provides clarification regarding the documents that are required for Sponsored Projects to begin negotiating an Industry Sponsored Clinical Trial Agreement. When participation in a trial appears likely, please submit to Sponsored Projects the documents listed below.

Required Minimum Documents:

• Initiate Kuali Coeus Proposal (must answer clinical trial questions under the “Questions” tab, within the “Compliance” panel)

Or

Draft Administrative Approval Form (if your unit is not required at this time to submit proposals via Kuali Coeus)

• Request for Exception to Principal Investigator Eligibility, if required.
• 700-U Financial Disclosure Form for Principal Investigator and/or Co-Principal Investigator (original to be forwarded to Office of Research)
• 700-U Addendum (If positive 700-U)
• Draft Budget
• Copy of Protocol
• Draft Agreement

More information regarding industry sponsored clinical trials can be found here: http://www.research.uci.edu/ora/ct/index.htm

Thank you for your cooperation. Should you have any questions, please contact Tam Tran, Assistant Director of Sponsored Projects at (949)824-7813 or via email at tamkt@uci.edu.