Abstract

The Siteman Cancer Center has placed the highest priority on ensuring the safety of patients participating in clinical trials. The SCC Data and Safety Monitoring Plan (NCI-approved in 2002) was developed to coordinate and provide oversight for data and safety monitoring for all cancer-related trials consistent with the National Institutes of Health Policy for Data and Safety Monitoring. Every clinical trial conducted at the Siteman Cancer Center must include a plan for data and safety monitoring. In addition, all institutional investigator-initiated clinical trials receive regular stringent quality assurance and safety monitoring. Oversight of data and safety monitoring is the responsibility of the Siteman Cancer Center Quality Assurance and Safety Monitoring Committee (QASMC). The QASMC independently reviews studies and has the power to close or suspend studies as warranted. Decisions, findings, and actions are communicated to the Protocol Review and Monitoring Committee (PRMC) (Section 9.2). The QASMC provides the following services for all institutional investigator-initiated clinical research studies: Independent oversight, performance and review of quality assurance audits Review and oversight of reportable adverse event (RAE) reporting Review and oversight of interim safety and monitoring reports

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA091842-13
Application #
8705894
Study Section
Subcommittee B - Comprehensiveness (NCI)
Project Start
Project End
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
13
Fiscal Year
2014
Total Cost
Indirect Cost

  Institution

Name
Washington University
Department
Type
DUNS #
City
Saint Louis
State
MO
Country
United States
Zip Code
63130

  Publications

Aliev, Fazil; Salvatore, Jessica E; Agrawal, Arpana et al. (2018) A Brief Critique of the TATES Procedure. Behav Genet 48:155-167
Mills, Jason C; Samuelson, Linda C (2018) Past Questions and Current Understanding About Gastric Cancer. Gastroenterology 155:939-944
Salloum, Naji C; Buchalter, Erica Lf; Chanani, Swati et al. (2018) From genes to treatments: a systematic review of the pharmacogenetics in smoking cessation. Pharmacogenomics 19:861-871
Dehdashti, Farrokh; Wu, Ningying; Bose, Ron et al. (2018) Evaluation of [89Zr]trastuzumab-PET/CT in differentiating HER2-positive from HER2-negative breast cancer. Breast Cancer Res Treat 169:523-530
Donabedian, Patrick L; Kossatz, Susanne; Engelbach, John A et al. (2018) Discriminating radiation injury from recurrent tumor with [18F]PARPi and amino acid PET in mouse models. EJNMMI Res 8:59
Shepherd, Andrew J; Copits, Bryan A; Mickle, Aaron D et al. (2018) Angiotensin II Triggers Peripheral Macrophage-to-Sensory Neuron Redox Crosstalk to Elicit Pain. J Neurosci 38:7032-7057
Andley, Usha P; Tycksen, Eric; McGlasson-Naumann, Brittney N et al. (2018) Probing the changes in gene expression due to ?-crystallin mutations in mouse models of hereditary human cataract. PLoS One 13:e0190817
Sáenz, José B; Mills, Jason C (2018) Acid and the basis for cellular plasticity and reprogramming in gastric repair and cancer. Nat Rev Gastroenterol Hepatol 15:257-273
Groves, Andrew P; Gettinger, Katie; Druley, Todd E et al. (2018) Special Therapy and Psychosocial Needs Identified in a Multidisciplinary Cancer Predisposition Syndrome Clinic. J Pediatr Hematol Oncol :
Ostrander, Elizabeth L; Koh, Won Kyun; Mallaney, Cates et al. (2018) The GNASR201C mutation associated with clonal hematopoiesis supports transplantable hematopoietic stem cell activity. Exp Hematol 57:14-20

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