The objectives of the Protocol Review and Monitoring System (PRMS) are to implement a transdisciplinary scientific peer-review system that ensures internal oversight of the scientific quality and progress of clinical trials and optimally engages the institution's resources. The system ensures that clinical research trials at the USC Norris Comprehensive Cancer Center (NCCC) are of the highest scientific quality and integrity by review of the scientific merit, priorities and progress.
The specific aims of the PRMS are to: 1) maintain a Clinical Investigation Committee (CIC) with sufficient breadth of expertise to conduct an objective scientific and operational review of all clinical cancer research protocols;2) facilitate prompt initiation of approved protocols by interfacing with the IRB to ensure compliance with local and federal regulations;3) ensure and oversee a system of prioritization of clinical research protocols;4) monitor the scientific progress of clinical research protocols and ensure closure as required by interim analysis and stopping rules;5) terminate clinical research protocols that fail to meet expectations for scientific progress;6) review amendments for ongoing clinical research protocols;and 7) monitor compliance as well as gender and minority accrual in the conduct of clinical research protocols. The CIC is assisted by the Quality Assurance and Monitoring Committee (QAMC) in the monitoring of the progress of the studies. The QAMC fulfills multiple functions as detailed in the CISO section of the grant. In regards to PRMS, it provides the essential data regarding accrual and study conduct to the CIC, which allows the latter to perform its progress monitoring functions optimally.

Public Health Relevance

As mandated by the Cancer Center, the Clinical Investigations Support Office provides essential assistance and support to investigators through the CIC and through the QAMC in order to ensure scientific quality and integrity starting with the initiation of each study and continuing to study completion.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA014089-39
Application #
8589360
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
39
Fiscal Year
2014
Total Cost
$156,053
Indirect Cost
$56,785
Name
University of Southern California
Department
Type
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Neumeyer, Sonja; Banbury, Barbara L; Arndt, Volker et al. (2018) Mendelian randomisation study of age at menarche and age at menopause and the risk of colorectal cancer. Br J Cancer 118:1639-1647
Basso, Virginia; Garcia, Angie; Tran, Dat Q et al. (2018) Fungicidal Potency and Mechanisms of ?-Defensins against Multidrug-Resistant Candida Species. Antimicrob Agents Chemother 62:
Austria, Theresa; Marion, Christine; Yu, Vanessa et al. (2018) Mechanism of cytokinesis failure in ovarian cystadenomas with defective BRCA1 and P53 pathways. Int J Cancer 143:2932-2942
Ning, Y; Zhang, W; Hanna, D L et al. (2018) Clinical relevance of EMT and stem-like gene expression in circulating tumor cells of metastatic colorectal cancer patients. Pharmacogenomics J 18:29-34
Battaglin, Francesca; Naseem, Madiha; Puccini, Alberto et al. (2018) Molecular biomarkers in gastro-esophageal cancer: recent developments, current trends and future directions. Cancer Cell Int 18:99
Zhang, Junjie; Zhao, Jun; Xu, Simin et al. (2018) Species-Specific Deamidation of cGAS by Herpes Simplex Virus UL37 Protein Facilitates Viral Replication. Cell Host Microbe 24:234-248.e5
Eriguchi, Yoshihiro; Nakamura, Kiminori; Yokoi, Yuki et al. (2018) Essential role of IFN-? in T cell-associated intestinal inflammation. JCI Insight 3:
Thomas, Nancy E; Edmiston, Sharon N; Orlow, Irene et al. (2018) Inherited Genetic Variants Associated with Melanoma BRAF/NRAS Subtypes. J Invest Dermatol 138:2398-2404
Cobo, Eduardo R; Holani, Ravi; Moreau, France et al. (2018) Entamoeba histolytica Alters ileal Paneth Cell Functions in Intact and Muc2 Mucin Deficiency. Infect Immun :
Suenaga, Mitsukuni; Schirripa, Marta; Cao, Shu et al. (2018) Gene Polymorphisms in the CCL5/CCR5 Pathway as a Genetic Biomarker for Outcome and Hand-Foot Skin Reaction in Metastatic Colorectal Cancer Patients Treated With Regorafenib. Clin Colorectal Cancer 17:e395-e414

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