Abstract

; The mission of the Protocol Review and Monitoring System (PRMS) is to provide internal oversight of all cancer clinical trials conducted at the OHSU Knight Cancer Institute to ensure both scientific integrity and the protection of human subjects through the course of the clinical research process. The PRMS includes initial scientific protocol review, real-time monitoring of protocol activity, monthly cumulative report review, annual review and final review. All components of the PRMS at the Knight are the responsibility of the Clinical Research Review Committee (CRRC). The CRRC is charged by the Knight Cancer Institute Director to ensure that all clinical trials and cancer-related research conducted at the Institute are: 1) scientifically meritorious;2) appropriately designed and statistically validated;3) feasible for completion within the specified time frame;4) to ensure clinical trial compliance with FDA and NIH guidelines;and, 5) compatible with the priorities, goals, and interests of the Institute. The functions of the CRRC are independent of the OHSU Institutional Review Board (IRB) and the Data and Safety Monitoring Committee (DSMC).

Public Health Relevance

The mission of the Protocol Review and Monitoring System (PRMS) is to provide internal oversight of all cancer clinical trials conducted at the OHSU Knight Cancer Institute to ensure both scientific integrity and the protection of human subjects through the course of the clinical research process.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
3P30CA069533-15S1
Application #
8530496
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
15
Fiscal Year
2012
Total Cost
$4,687
Indirect Cost
$1,136

  Institution

Name
Oregon Health and Science University
Department
Type
DUNS #
096997515
City
Portland
State
OR
Country
United States
Zip Code
97239

  Publications

Winters-Stone, Kerri M; Wood, Lisa J; Stoyles, Sydnee et al. (2018) The Effects of Resistance Exercise on Biomarkers of Breast Cancer Prognosis: A Pooled Analysis of Three Randomized Trials. Cancer Epidemiol Biomarkers Prev 27:146-153
Pennock, Nathan D; Martinson, Holly A; Guo, Qiuchen et al. (2018) Ibuprofen supports macrophage differentiation, T cell recruitment, and tumor suppression in a model of postpartum breast cancer. J Immunother Cancer 6:98
Xu, Li; Gordon, Ryan; Farmer, Rebecca et al. (2018) Precision therapeutic targeting of human cancer cell motility. Nat Commun 9:2454
Chen, Emerson Y; Blanke, Charles D; Haller, Daniel G et al. (2018) A Phase II Study of Celecoxib With Irinotecan, 5-Fluorouracil, and Leucovorin in Patients With Previously Untreated Advanced or Metastatic Colorectal Cancer. Am J Clin Oncol 41:1193-1198
Lane, Ryan S; Femel, Julia; Breazeale, Alec P et al. (2018) IFN?-activated dermal lymphatic vessels inhibit cytotoxic T cells in melanoma and inflamed skin. J Exp Med 215:3057-3074
Smith, Nicholas R; Swain, John R; Davies, Paige S et al. (2018) Monoclonal Antibodies Reveal Dynamic Plasticity Between Lgr5- and Bmi1-Expressing Intestinal Cell Populations. Cell Mol Gastroenterol Hepatol 6:79-96
Langer, E M; Kendsersky, N D; Daniel, C J et al. (2018) ZEB1-repressed microRNAs inhibit autocrine signaling that promotes vascular mimicry of breast cancer cells. Oncogene 37:1005-1019
Sorace, Anna G; Partridge, Savannah C; Li, Xia et al. (2018) Distinguishing benign and malignant breast tumors: preliminary comparison of kinetic modeling approaches using multi-institutional dynamic contrast-enhanced MRI data from the International Breast MR Consortium 6883 trial. J Med Imaging (Bellingham) 5:011019
Medler, Terry R; Murugan, Dhaarini; Horton, Wesley et al. (2018) Complement C5a Fosters Squamous Carcinogenesis and Limits T Cell Response to Chemotherapy. Cancer Cell 34:561-578.e6
Kelley, Katherine A; Wieghard, Nicole; Chin, Yuki et al. (2018) MiR-486-5p Downregulation Marks an Early Event in Colorectal Carcinogenesis. Dis Colon Rectum 61:1290-1296

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