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 #
5P30CA091842-11
Application #
8380325
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
11
Fiscal Year
2012
Total Cost
$171,659
Indirect Cost
$55,503

  Institution

Name
Washington University
Department
Type
DUNS #
068552207
City
Saint Louis
State
MO
Country
United States
Zip Code
63130

  Publications

Waqar, Saiama N; Waqar, Sadaf H; Trinkaus, Kathryn et al. (2018) Brain Metastases at Presentation in Patients With Non-Small Cell Lung Cancer. Am J Clin Oncol 41:36-40
May-Zhang, Aaron A; Deal, Karen K; Southard-Smith, E Michelle (2018) Optimization of Laser-Capture Microdissection for the Isolation of Enteric Ganglia from Fresh-Frozen Human Tissue. J Vis Exp :
Harris-Hayes, Marcie; Steger-May, Karen; van Dillen, Linda R et al. (2018) Reduced Hip Adduction Is Associated With Improved Function After Movement-Pattern Training in Young People With Chronic Hip Joint Pain. J Orthop Sports Phys Ther 48:316-324
Beleckas, Casey M; Gerull, William; Wright, Melissa et al. (2018) Variability of PROMIS Scores Across Hand Conditions. J Hand Surg Am :
Prudner, Bethany Cheree; Sun, Fangdi; Kremer, Jeffrey Charles et al. (2018) Amino Acid Uptake Measured by [18F]AFETP Increases in Response to Arginine Starvation in ASS1-Deficient Sarcomas. Theranostics 8:2107-2116
Mundt, Filip; Rajput, Sandeep; Li, Shunqiang et al. (2018) Mass Spectrometry-Based Proteomics Reveals Potential Roles of NEK9 and MAP2K4 in Resistance to PI3K Inhibition in Triple-Negative Breast Cancers. Cancer Res 78:2732-2746
Burclaff, Joseph; Mills, Jason C (2018) Plasticity of differentiated cells in wound repair and tumorigenesis, part I: stomach and pancreas. Dis Model Mech 11:
Meinerz, Kelsey; Beeman, Scott C; Duan, Chong et al. (2018) Bayesian Modeling of NMR Data: Quantifying Longitudinal Relaxation in Vivo, and in Vitro with a Tissue-Water-Relaxation Mimic (Crosslinked Bovine Serum Albumin). Appl Magn Reson 49:3-24
Rocha, Agostinho G; Franco, Antonietta; Krezel, Andrzej M et al. (2018) MFN2 agonists reverse mitochondrial defects in preclinical models of Charcot-Marie-Tooth disease type 2A. Science 360:336-341
Lin, Jonathan B; Sene, Abdoulaye; Santeford, Andrea et al. (2018) Oxysterol Signatures Distinguish Age-Related Macular Degeneration from Physiologic Aging. EBioMedicine 32:9-20

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