Submission Guidelines for Clinical Trials
Most cancer relevant clinical trials at the Holden Comprehensive Cancer Center at the University of Iowa are reviewed by the Protocol Review and Monitoring Committee (PRMC).
The purpose of the review is
- To conduct a scientific review of proposed and ongoing institutional cancer clinical research
- To determine prioritization of patient referrals to competing protocols
- To monitor clinical cancer research protocols for sufficient progress
- To terminate those cancer protocols that are not achieving goals in a reasonable time frame
Please submit a Protocol Submission Form unless your study is
- A single, compassionate use treatment
- A retrospective chart or registry review of existing data
- A rationale or methodology for establishing a tissue bank or registry*
- Population based research involving non-therapeutic interventions*
- Research that only involves patient populations outside the University of Iowa not directly cared for by physicians in the Holden Comprehensive Cancer Center
*While in some cases scientific review by the PRMC may not be required, enrollment of cancer center patients in the above trials may require accrual reporting.
No protocol may have access to Cancer Center shared resources without full approval of the committee.
To ensure efficient use of Cancer Center resources for clinical trials, protocols submitted to the PRMC must also be approved by the appropriate Multidisciplinary Oncology Group (MOG). Final approval by the PRMC will be contingent upon approval by the MOG. To verify approval, please complete the Multidisciplinary Oncology Group Clinical Trial Review Form and submit as part of the PRMC Submission Packet.
PRMC Supporting Forms and Documentation:
- Protocol Submission Form
- Multidisciplinary Oncology Group Clinical Trial Review Form
- G-12 Completion Guidelines (MS Word Format)
- G-12 New Drug Form Template 12-18-07
- Cytochrome P450 Drug-Interaction Table