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 #
5P30CA056036-13
Application #
8378897
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2012-06-01
Budget End
2013-05-31
Support Year
13
Fiscal Year
2012
Total Cost
$70,719
Indirect Cost
$24,779

  Institution

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

  Publications

Heeke, Arielle L; Pishvaian, Michael J; Lynce, Filipa et al. (2018) Prevalence of Homologous Recombination-Related Gene Mutations Across Multiple Cancer Types. JCO Precis Oncol 2018:
Parent, Kristin N; Schrad, Jason R; Cingolani, Gino (2018) Breaking Symmetry in Viral Icosahedral Capsids as Seen through the Lenses of X-ray Crystallography and Cryo-Electron Microscopy. Viruses 10:
Rappaport, Jeffrey A; Waldman, Scott A (2018) The Guanylate Cyclase C-cGMP Signaling Axis Opposes Intestinal Epithelial Injury and Neoplasia. Front Oncol 8:299
Pandya, Kalgi D; Palomo-Caturla, Isabel; Walker, Justin A et al. (2018) An Unmutated IgM Response to the Vi Polysaccharide of Salmonella Typhi Contributes to Protective Immunity in a Murine Model of Typhoid. J Immunol 200:4078-4084
Hussain, Maha; Daignault-Newton, Stephanie; Twardowski, Przemyslaw W et al. (2018) Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012. J Clin Oncol 36:991-999
Shafi, Ayesha A; Schiewer, Matthew J; de Leeuw, Renée et al. (2018) Patient-derived Models Reveal Impact of the Tumor Microenvironment on Therapeutic Response. Eur Urol Oncol 1:325-337
Meyer, Sara E; Muench, David E; Rogers, Andrew M et al. (2018) miR-196b target screen reveals mechanisms maintaining leukemia stemness with therapeutic potential. J Exp Med 215:2115-2136
Mazina, Olga M; Mazin, Alexander V (2018) Reconstituting the 4-Strand DNA Strand Exchange. Methods Enzymol 600:285-305
Magee, Michael S; Abraham, Tara S; Baybutt, Trevor R et al. (2018) Human GUCY2C-Targeted Chimeric Antigen Receptor (CAR)-Expressing T Cells Eliminate Colorectal Cancer Metastases. Cancer Immunol Res 6:509-516
Chervoneva, Inna; Freydin, Boris; Hyslop, Terry et al. (2018) Modeling qRT-PCR dynamics with application to cancer biomarker quantification. Stat Methods Med Res 27:2581-2595

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