The University of Colorado Cancer Center clinical trials originate from cooperative group participation, selected pharmaceutical trials and investigator-initiated studies using funding from external peer-reviewed mechanisms or internal peer-reviewed mechanisms.
Please Keep This in Mind
New studies will not be brought forward if there is direct, irreconcilable conflict with an existing protocol unless the competing protocol is nearing target accrual.
Protocol Approval Process
- Submit your final clinical trial protocol to the Regulatory Team Leader, Jennifer Maitlen, RN. Dr. Madeleine Kane (Medical Director), Andrea Buchmeier (Clinical Director) and the Disease Site Chair will review your protocol.
- If there are no directly competing trials and your accrual targets are reasonable, the Disease Site Regulatory Affairs Coordinator will prepare your protocol for submission to the following committees or boards:
- The Finance Team drafts a study budget and begins negotiation with the sponsor, the UC Denver Grants and Contracts Office and the HRRC. Investigator-initiated studies without sponsored funding are prioritized for support by the Protocol Specific Research Core.
- Once all approvals are finalized, patient recruitment and enrollment begins.
Once a study protocol has been approved and opened as described above, it is entered into the CU Cancer Center Clinical Trials Database, which can be accessed by appropriate staff using an authorized password.