UCCC Protocol Approval Process

UCCC 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.

• Disease Site Working Groups refine a study question after consideration of fit of the study into the palette of protocols offered by the particular disease site. 
• Multidisciplinary Working Groups for each disease site routinely discuss, review and prioritize protocols for activation. 

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.

The Protocol Approval Process

1. 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.
2. 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:
   • Protocol Review and Monitoring Committee (PRMC). PRMC scientific and feasibility review and approval must be complete before your protocol is submitted to the other approval bodies.IRB will not review a cancer-related study if it has not first been approved by PRMC. 
   • IRB (Colorado Multiple Institutional Review Board (COMIRB), or Western Institutional Review Board (WIRB). Early phase industry-sponsored trials are submitted to WIRB via a process that flows through COMIRB.
   • University of Colorado Denver Institutional Biosafety Committee
   • Hospital Research Review Committees
3. 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. 
4. Once all approvals are finalized, patient recruitment and enrollment begins.

Data Safety and Quality Assurance

The UCCC Protocol Quality Assurance and Safety Committee  (PQASC) provides protocol data safety and monitoring, and CIC quality assurance measures ensure that all aspects of clinical trials perform optimally.

After Approval

Once a study protocol has been approved and opened as described above, it is entered into the UCCC Clinical Trials Database, which can be accessed by appropriate staff using an authorized password.

• The CIC makes a lay description of each study available on the University of Colorado Hospital website (www.uch.edu) and the University of Colorado Cancer Center website (www.uccc.info) and in the UCCC Clinical Trials Priority Booklet
• The CIC posts each study to the NCI Clinical Trials website (www.clinicaltrials.gov)
• Clinical research coordinators identify possible study subjects by talking with the PI in clinic, attending UCCC Tumor Board and disease site tumor conferences and by distributing disease site newsletters to referring physicians.
• Once a study reaches its target accrual goal and follow-up interval, the investigators and statisticians review the data and prepare a manuscript.