Abstract

DATA AND SAFETY MONITORING The Data and Safety Monitoring Plan (DSMP) of the Kimmel Cancer Center (KCC) provides for the oversight and monitoring of clinical trials to ensure the: 1. Safety of patients;and 2. Validity and integrity of the data collected on these trials. Responsibility for data and safety monitoring at Thomas Jefferson University resides in: 1. The Clinical Cancer Research Review Committee (CCRRC) which oversees the scientific review of all new and ongoing cancer-related clinical trials within the KCC; 2. The Clinical Research Management Office (CRMO) which provides strategic assistance and support to the CCRRC; 3. The IRB which has primary responsibility for the protection of the welfare of human subjects involved in biomedical and behavioral research. The IRB has full authority to approve, request modifications prior to approval, disapprove, suspend or terminate for cause all research activities that fall within its jurisdiction;and 4. The Data and Safety Monitoring Boards (DSMB), which are responsible for data and safety monitoring of Kimmel Cancer Center investigator initiated trials (KCC NT). The DSMP requires that every Kimmel Cancer Center protocol include a Data and Safety Monitoring plan. The CCRRC will not review a study that does not have such a plan, and the TJU IRB will not accept a study for review and approval until it has been approved by the CCRRC.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA056036-11
Application #
8084112
Study Section
Subcommittee G - Education (NCI)
Project Start
2010-06-03
Project End
2013-05-31
Budget Start
2010-06-01
Budget End
2011-05-31
Support Year
11
Fiscal Year
2010
Total Cost
$76,836
Indirect Cost

  Institution

Name
Thomas Jefferson University
Department
Type
DUNS #
053284659
City
Philadelphia
State
PA
Country
United States
Zip Code
19107

  Publications

Peng, Weidan; Furuuchi, Narumi; Aslanukova, Ludmila et al. (2018) Elevated HuR in Pancreas Promotes a Pancreatitis-Like Inflammatory Microenvironment That Facilitates Tumor Development. Mol Cell Biol 38:
Waldman, Scott A; Camilleri, Michael (2018) Guanylate cyclase-C as a therapeutic target in gastrointestinal disorders. Gut 67:1543-1552
Sullivan-Reed, Katherine; Bolton-Gillespie, Elisabeth; Dasgupta, Yashodhara et al. (2018) Simultaneous Targeting of PARP1 and RAD52 Triggers Dual Synthetic Lethality in BRCA-Deficient Tumor Cells. Cell Rep 23:3127-3136
Lu, Huimin; Bowler, Nicholas; Harshyne, Larry A et al. (2018) Exosomal ?v?6 integrin is required for monocyte M2 polarization in prostate cancer. Matrix Biol 70:20-35
Lapadula, Dominic; Farias, Eduardo; Randolph, Clinita E et al. (2018) Effects of Oncogenic G?q and G?11 Inhibition by FR900359 in Uveal Melanoma. Mol Cancer Res :
Vite, Alexia; Zhang, Caimei; Yi, Roslyn et al. (2018) ?-Catenin-dependent cytoskeletal tension controls Yap activity in the heart. Development 145:
McNair, Christopher; Xu, Kexin; Mandigo, Amy C et al. (2018) Differential impact of RB status on E2F1 reprogramming in human cancer. J Clin Invest 128:341-358
Garcia, Samantha A; Lebrun, Aurore; Kean, Rhonda B et al. (2018) Clearance of attenuated rabies virus from brain tissues is required for long-term protection against CNS challenge with a pathogenic variant. J Neurovirol 24:606-615
Vido, Michael J; Le, Kaitlyn; Hartsough, Edward J et al. (2018) BRAF Splice Variant Resistance to RAF Inhibitor Requires Enhanced MEK Association. Cell Rep 25:1501-1510.e3
Brody, Jonathan R; Dixon, Dan A (2018) Complex HuR function in pancreatic cancer cells. Wiley Interdiscip Rev RNA 9:e1469

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