Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM The UNC Lineberger Comprehensive Cancer Center?s Protocol Review and Monitoring System (PRMS) facilitates internal oversight of the scientific aspects of all cancer clinical trials at the University of North Carolina focusing on the scientific merit, priorities, and progress of clinical protocol research. The system is a multi-step process with preliminary review by Protocol Office Disease teams (PODs) and the Resource and Feasibility Team (RAFT) followed by formal scientific review by the Protocol Review Committee (PRC). The PRC is chaired by Autumn McRee, MD, and meets bi-monthly to review every cancer-related clinical protocol before it is submitted to The Office of Human Research Ethics? Institutional Review Board (IRB). The PRC?s primary function is to ensure the scientific quality of proposed studies. As described in Clinical Protocol and Data Management (CPDM), PODs and RAFT review protocols for feasibility, quality, and priority before they are submitted to the PRC. The PRC monitors study accrual and has the authority to close under- performing trials. During 2019, the PRC reviewed 392 protocols: 156 new studies and 236 active trials for renewal and monitoring. This represents an 8% increase over the PRMS activity at the time of our last renewal and reflects both our growth and dedication to an effective PRMS process.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA016086-45
Application #
10089824
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
1997-06-01
Project End
2025-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
45
Fiscal Year
2021
Total Cost
Indirect Cost

  Institution

Name
University of North Carolina Chapel Hill
Department
Type
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599

  Publications

Ma, Shaohua; Paiboonrungruan, Chorlada; Yan, Tiansheng et al. (2018) Targeted therapy of esophageal squamous cell carcinoma: the NRF2 signaling pathway as target. Ann N Y Acad Sci 1434:164-172
Aung, Kyaw L; Fischer, Sandra E; Denroche, Robert E et al. (2018) Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial. Clin Cancer Res 24:1344-1354
Suh, Junghyun L; Watts, Brian; Stuckey, Jacob I et al. (2018) Quantitative Characterization of Bivalent Probes for a Dual Bromodomain Protein, Transcription Initiation Factor TFIID Subunit 1. Biochemistry 57:2140-2149
Brock, William J; Beaudoin, James J; Slizgi, Jason R et al. (2018) Bile Acids as Potential Biomarkers to Assess Liver Impairment in Polycystic Kidney Disease. Int J Toxicol 37:144-154
Thomas, Nancy E; Edmiston, Sharon N; Tsai, Yihsuan S et al. (2018) Utility of TERT Promoter Mutations for Cutaneous Primary Melanoma Diagnosis. Am J Dermatopathol :
Bensen, Jeannette T; Graff, Mariaelisa; Young, Kristin L et al. (2018) A survey of microRNA single nucleotide polymorphisms identifies novel breast cancer susceptibility loci in a case-control, population-based study of African-American women. Breast Cancer Res 20:45
Hall, Marissa G; Marteau, Theresa M; Sunstein, Cass R et al. (2018) Public support for pictorial warnings on cigarette packs: an experimental study of US smokers. J Behav Med 41:398-405
Thorsson, Vésteinn; Gibbs, David L; Brown, Scott D et al. (2018) The Immune Landscape of Cancer. Immunity 48:812-830.e14
Wu, Bing; Zhang, Song; Guo, Zengli et al. (2018) RAS P21 Protein Activator 3 (RASA3) Specifically Promotes Pathogenic T Helper 17 Cell Generation by Repressing T-Helper-2-Cell-Biased Programs. Immunity 49:886-898.e5
Ding, Li; Bailey, Matthew H; Porta-Pardo, Eduard et al. (2018) Perspective on Oncogenic Processes at the End of the Beginning of Cancer Genomics. Cell 173:305-320.e10

Showing the most recent 10 out of 1525 publications