Abstract

The Protocol Review and Monitoring System consists of the Protocol Review and Monitoring Committee (PRMC) and its subcommittee, the Quality Assurance Committee (QA). The PRMC meets biweekly to review newly submitted interventional protocols. The PRMC has three functions: 1. Review protocols for scientific merit and prioritization to assure efficient use of HICCC resources;2. Monitor accrual and close trials that fail to demonstrate activity;3. Review and act on reports from the QA Committee. The PRMC also provides support to investigators regarding design of informed consents. The QA Committee conducts periodic audits on investigator initiated trials and reviews data audits conducted by cooperative groups and by trial sponsors/The QA also interacts with the IRB and with Theradex or other independent auditing groups to assure that there is periodic monitoring of the conduct of institutional trials at HICCC. The projected operating budget of the PRMS is $318,332, of which we are requesting $151,915 from the CCSG.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
3P30CA013696-39S3
Application #
8637180
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-07-04
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
39
Fiscal Year
2013
Total Cost
$136,392
Indirect Cost
$51,147

  Institution

Name
Columbia University (N.Y.)
Department
Type
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032

  Publications

O'Neil, Daniel S; Prigerson, Holly G; Mmoledi, Keletso et al. (2018) Informal Caregiver Challenges for Advanced Cancer Patients During End-of-Life Care in Johannesburg, South Africa and Distinctions Based on Place of Death. J Pain Symptom Manage 56:98-106
Jauregui, Ruben; Park, Karen Sophia; Duong, Jimmy K et al. (2018) Quantitative progression of retinitis pigmentosa by optical coherence tomography angiography. Sci Rep 8:13130
Liu, Katherine Y; Sengillo, Jesse D; Velez, Gabriel et al. (2018) Missense mutation in SLIT2 associated with congenital myopia, anisometropia, connective tissue abnormalities, and obesity. Orphanet J Rare Dis 13:138
Koch, Susanne F; Tsang, Stephen H (2018) Success of Gene Therapy in Late-Stage Treatment. Adv Exp Med Biol 1074:101-107
DiCarlo, James E; Mahajan, Vinit B; Tsang, Stephen H (2018) Gene therapy and genome surgery in the retina. J Clin Invest 128:2177-2188
Wert, Katherine J; Velez, Gabriel; Cross, Madeline R et al. (2018) Extracellular superoxide dismutase (SOD3) regulates oxidative stress at the vitreoretinal interface. Free Radic Biol Med 124:408-419
Lee, Andreia; CingÖz, Oya; Sabo, Yosef et al. (2018) Characterization of interaction between Trim28 and YY1 in silencing proviral DNA of Moloney murine leukemia virus. Virology 516:165-175
Schrank, Benjamin R; Aparicio, Tomas; Li, Yinyin et al. (2018) Nuclear ARP2/3 drives DNA break clustering for homology-directed repair. Nature 559:61-66
Proto, Jonathan D; Doran, Amanda C; Gusarova, Galina et al. (2018) Regulatory T Cells Promote Macrophage Efferocytosis during Inflammation Resolution. Immunity 49:666-677.e6
Hernandez, Celine; Huebener, Peter; Pradere, Jean-Philippe et al. (2018) HMGB1 links chronic liver injury to progenitor responses and hepatocarcinogenesis. J Clin Invest 128:2436-2451

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