Data and Safety Monitoring at the Helen Diller Family Comprehensive Cancer Center is overseen by a Data and Safety Monitoring Committee (DSMC), and conducted by a group of monitors and auditors within the Center. The DSMC and monitors are responsible for several activities related to the implementation of the Center's NCI-approved Data and Safety Monitoring Plan (DSMP). Data and Safety and Monitoring functions within the HDFCCC include 1) the conduct of internal audits of protocols;2) evaluation of the results of both internal and external audits of protocols, including those conducted by the NCI Cooperative Groups, other consortia, and CTEP;3) review and approval of any cohort dose escalation decisions on UCSF Institutional Phase I studies;4) review of interim analyses for institutional studies;5) evaluation and addressing of any concerns with regards to safety, or related study design and stopping rules, raised by principal investigators, site committees, the Protocol Review Committee (PRC), or Institutional Review Board (IRB);6) oversight of toxicity and Serious Adverse Events (SAEs) reported by each site committee;7) development and updating of the DSMP and guidelines for its use;8) communication of findings and recommendations with key stakeholders, including the PRC, IRB, and leadership of the Center;and 9) closure of studies for noncompliance or safety issues.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA082103-14
Application #
8388388
Study Section
Subcommittee G - Education (NCI)
Project Start
1999-08-05
Project End
2017-05-31
Budget Start
2012-09-19
Budget End
2013-05-31
Support Year
14
Fiscal Year
2012
Total Cost
$517,813
Indirect Cost
$187,118
Name
University of California San Francisco
Department
Type
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Autry, Adam; Phillips, Joanna J; Maleschlijski, Stojan et al. (2017) Characterization of Metabolic, Diffusion, and Perfusion Properties in GBM: Contrast-Enhancing versus Non-Enhancing Tumor. Transl Oncol 10:895-903
Pekmezci, Melike; Rice, Terri; Molinaro, Annette M et al. (2017) Adult infiltrating gliomas with WHO 2016 integrated diagnosis: additional prognostic roles of ATRX and TERT. Acta Neuropathol 133:1001-1016
Maertens, Ophélia; McCurrach, Mila E; Braun, Benjamin S et al. (2017) A Collaborative Model for Accelerating the Discovery and Translation of Cancer Therapies. Cancer Res 77:5706-5711
de Smith, Adam J; Kaur, Maneet; Gonseth, Semira et al. (2017) Correlates of Prenatal and Early-Life Tobacco Smoke Exposure and Frequency of Common Gene Deletions in Childhood Acute Lymphoblastic Leukemia. Cancer Res 77:1674-1683
Stieglitz, Elliot; Mazor, Tali; Olshen, Adam B et al. (2017) Genome-wide DNA methylation is predictive of outcome in juvenile myelomonocytic leukemia. Nat Commun 8:2127
Bartlett, Thomas E; Müller, Sören; Diaz, Aaron (2017) Single-cell Co-expression Subnetwork Analysis. Sci Rep 7:15066
Martin, Thomas; Baz, Rachid; Benson, Don M et al. (2017) A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. Blood 129:3294-3303
Zhang, Jie; Yao, Tsun-Wen; Hashizume, Rintaro et al. (2017) Combined BRAFV600E and MEK blockade for BRAFV600E-mutant gliomas. J Neurooncol 131:495-505
Li, Megan; Kroetz, Deanna L (2017) Bevacizumab-induced hypertension: Clinical presentation and molecular understanding. Pharmacol Ther :
Aggarwal, Rahul; Behr, Spencer C; Paris, Pamela L et al. (2017) Real-Time Transferrin-Based PET Detects MYC-Positive Prostate Cancer. Mol Cancer Res 15:1221-1229

Showing the most recent 10 out of 168 publications