The Protocol Review and Monitoring System (PRMS) was implemented in 1990 to oversee research involving cancer patients in the facilifies of the institutions that define KCI. The main objectives of the PRMS include the following: 1) review the scientific merit of cancer research protocols;2) ensure prioritizafion of therapeufic cancer protocols according to KCI's scientific priorities;and 3) monitor scienfific proqress. The Protocol Review and Monitoring Committee is composed of a complementary mix of senior and junior investigators from various disciplines, and specialfies, as well as representatives from the Biostatistics Core, nursing and physician extenders, and administrafive support staff from the Clinical Trials Office Core. The members of the committee represent a sufficient size, and breadth of expertise to conduct a critical, fair scienfific review of all clinical research protocols involving cancer patients in the institufions comprising the Cancer Center. The PRMS provides internal oversight of the scientific and research aspects of the cancer trials, in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applicafions. The function of the PRMS is complementary to that ofthe WSU Human Investigations Committee (HIC), which focuses on the protecfion of human subjects. The PRMS is not intended to duplicate or overiap the responsibilifies of the WSU HIC, nor is it intended to perform an audifing or data and safety monitoring function. The PRMS evaluates all cancer clinical trials, whether derived and supported from institutional resources or from industry. However, the PRMS does not duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms (e.g., ROIs, UOIs, POIs, UIOs and P50s), and clinical research protocols approved by the NCI's Cancer Therapy Evaluafion Program. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere and at the Cancer Center, adequacy of biostafistical input, and feasibility for complefion of the study within a reasonable time frame.

Public Health Relevance

The PRMS provides internal oversight of the scientific aspects of clinical trials at KCI, closely monitoring the scientific merit, scientific priorities, and the scientific progress of KCI's clinical research. The PRMS complements the functions of the IRB, which focuses on protection of human subjects at KCI. Protocols approved by the PRMS for activafion are submitted to the IRB for further review.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA022453-29
Application #
8350789
Study Section
Subcommittee G - Education (NCI)
Project Start
2011-09-06
Project End
2015-11-30
Budget Start
2011-09-06
Budget End
2011-11-30
Support Year
29
Fiscal Year
2011
Total Cost
$113,159
Indirect Cost
Name
Wayne State University
Department
Type
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
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