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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Townsley, Loni; Yannarell, Sarah M; Huynh, Tuanh Ngoc et al. (2018) Cyclic di-AMP Acts as an Extracellular Signal That Impacts Bacillus subtilis Biofilm Formation and Plant Attachment. MBio 9:
Schulfer, Anjelique F; Battaglia, Thomas; Alvarez, Yelina et al. (2018) Intergenerational transfer of antibiotic-perturbed microbiota enhances colitis in susceptible mice. Nat Microbiol 3:234-242
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Che, Tao; Majumdar, Susruta; Zaidi, Saheem A et al. (2018) Structure of the Nanobody-Stabilized Active State of the Kappa Opioid Receptor. Cell 172:55-67.e15
Cranston, Ross D; Cespedes, Michelle S; Paczuski, Pawel et al. (2018) High Baseline Anal Human Papillomavirus and Abnormal Anal Cytology in a Phase 3 Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Individuals Older Than 26 Years: ACTG 5298. Sex Transm Dis 45:266-271
DeBono, Nathan L; Robinson, Whitney R; Lund, Jennifer L et al. (2018) Race, Menopausal Hormone Therapy, and Invasive Breast Cancer in the Carolina Breast Cancer Study. J Womens Health (Larchmt) 27:377-386
Okolie, Onyinyechukwu; Irvin, David M; Bago, Juli R et al. (2018) Intra-cavity stem cell therapy inhibits tumor progression in a novel murine model of medulloblastoma surgical resection. PLoS One 13:e0198596

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