Version Date: August 1, 2011
Guidance for identifying the necessity of the PRMC scientific review in the ARROW SmartForm application
The National Cancer Institute (NCI) mandates that all NCI-designated Comprehensive Cancer Centers have a Protocol Review and Monitoring System as part of the institution.The Protocol Review and Monitoring Committee is part of this system and is responsible for reviewing all cancer-related trials at the University of Wisconsin – Madison.
The PRMC reviews protocols for scientific merit, study design, prioritization of resources, feasibility, and an adequate data and safety monitoring plan. PRMC review and approval are required prior to review by the IRB, and fulfills the IRB’s requirement for scientific review. For protocol submission documents and guidelines or contact the PRMC Coordinator at firstname.lastname@example.org, (608) 263-0169.
Guidance to completing the ARROW SmartForm application to identify the necessity for the scientific review from the UWCCC PRMC:
- Is the scientific question of the protocol cancer related? Does the hypothesis of the study aim to develop the understanding of cancer or its mechanisms? If so, answer "yes" to this question.
- Are you specifically targeting cancer patients for enrollment in this study? If the target population for the study is current or past cancer patients, answer "yes" to this question. If the target population of the study is the general population, or a selected demographic not specific to cancer, but does not necessarily exclude cancer patients, answer "no" to this question.
- Does this study involve the review and/or use of biological specimens/data/images/records from cancer patients? If this study includes blood or tissues samples, surveys, interviews, chart reviews, medical records, registries, or image analysis from cancer patients, answer "yes" to this question.
If you answered yes to any of the above questions, PRMC submission will be required. For more information about the review process, PRMC documents and guidelines, please visit the PRMC website.