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

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Smith, Jennifer S; Des Marais, Andrea C; Deal, Allison M et al. (2018) Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States. Sex Transm Dis 45:42-48
Morris, Michael J; Rumble, R Bryan; Basch, Ethan et al. (2018) Optimizing Anticancer Therapy in Metastatic Non-Castrate Prostate Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 36:1521-1539
Hisada, Yohei; Thålin, Charlotte; Lundström, Staffan et al. (2018) Comparison of microvesicle tissue factor activity in non-cancer severely ill patients and cancer patients. Thromb Res 165:1-5
Westmoreland, Katherine D; El-Mallawany, Nader K; Kazembe, Peter et al. (2018) Dissecting heterogeneous outcomes for paediatric Burkitt lymphoma in Malawi after anthracycline-based treatment. Br J Haematol 181:853-854
Kulis, Michael; Yue, Xiaohong; Guo, Rishu et al. (2018) High- and low-dose oral immunotherapy similarly suppress pro-allergic cytokines and basophil activation in young children. Clin Exp Allergy :
Knott, Simon R V; Wagenblast, Elvin; Khan, Showkhin et al. (2018) Asparagine bioavailability governs metastasis in a model of breast cancer. Nature 554:378-381
Wu, Jing; Frady, Lauren N; Bash, Ryan E et al. (2018) MerTK as a therapeutic target in glioblastoma. Neuro Oncol 20:92-102
Wu, Shih-Ying; Fix, Samantha M; Arena, Christopher B et al. (2018) Focused ultrasound-facilitated brain drug delivery using optimized nanodroplets: vaporization efficiency dictates large molecular delivery. Phys Med Biol 63:035002

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