Member Responsibilities and Qualifications
The chairperson of the PRMC will provide leadership and direction for the scientific review of cancer and cancer related trials and in this capacity may also provide:
- Input to the KUCC's Director regarding the conduct of cancer clinical trials;
- Review of Quality Assurance/Quality Control reports and provide recommendations;
- Provide internal scientific review for all new cancer and cancer related studies as well as scientific progress and accrual progress of active protocols;
- Reviews all Data Safety and Monitoring Plans for appropriateness;
- Provide internal review of adverse events on active protocols;
- Prioritize competing studies and resources based on KUCC's institutional prioritization plan; and
- Review the statistical analysis plan and appropriateness of trial design
If a PRMC member is unable to attend a meeting, The Chair will recruit a qualified KUCC member if needed.
The Chairperson of the Protocol Review and Monitoring Committee appoints members to the PRMC from all relevant programs in the institution. These persons should have an interest and be knowledgeable in protocol development and the conduct of clinical trials.
The PRMC will include:
- The Chair
- KUCC members (physicians, basic scientists, etc.)
- Oncology Research Nurses
Each study requiring full committee review will be reviewed by 4 committee members including a biostatistician.
Cooperative group studies have been reviewed extensively by NCI and various other national groups; therefore the PRMC will require an administrative review by the Chair, or Chair designee for these studies.