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

Terry, Erin E; Zhang, Xiping; Hoffmann, Christy et al. (2018) Transcriptional profiling reveals extraordinary diversity among skeletal muscle tissues. Elife 7:
Howard, Nicole C; Marin, Nancy D; Ahmed, Mushtaq et al. (2018) Mycobacterium tuberculosis carrying a rifampicin drug resistance mutation reprograms macrophage metabolism through cell wall lipid changes. Nat Microbiol 3:1099-1108
Alimujiang, Aliya; Colditz, Graham A; Gardner, Jane D et al. (2018) Childhood diet and growth in boys in relation to timing of puberty and adult height: the Longitudinal Studies of Child Health and Development. Cancer Causes Control 29:915-926
Brenot, Audrey; Knolhoff, Brett L; DeNardo, David G et al. (2018) SNAIL1 action in tumor cells influences macrophage polarization and metastasis in breast cancer through altered GM-CSF secretion. Oncogenesis 7:32
Soll, Jennifer M; Brickner, Joshua R; Mudge, Miranda C et al. (2018) RNA ligase-like domain in activating signal cointegrator 1 complex subunit 1 (ASCC1) regulates ASCC complex function during alkylation damage. J Biol Chem 293:13524-13533
Ahmed, Abu Shufian Ishtiaq; Dong, Kunzhe; Liu, Jinhua et al. (2018) Long noncoding RNA NEAT1 (nuclear paraspeckle assembly transcript 1) is critical for phenotypic switching of vascular smooth muscle cells. Proc Natl Acad Sci U S A 115:E8660-E8667
Jin, Ramon U; Mills, Jason C (2018) Are Gastric and Esophageal Metaplasia Relatives? The Case for Barrett's Stemming from SPEM. Dig Dis Sci 63:2028-2041
Gonzalez, Kim L; Ratzel, Sarah E; Burks, Kendall H et al. (2018) A pex1 missense mutation improves peroxisome function in a subset of Arabidopsis pex6 mutants without restoring PEX5 recycling. Proc Natl Acad Sci U S A 115:E3163-E3172
VanDussen, Kelli L; Stojmirovi?, Aleksandar; Li, Katherine et al. (2018) Abnormal Small Intestinal Epithelial Microvilli in Patients With Crohn's Disease. Gastroenterology 155:815-828
Lin, Huawen; Cliften, Paul F; Dutcher, Susan K (2018) MAPINS, a Highly Efficient Detection Method That Identifies Insertional Mutations and Complex DNA Rearrangements. Plant Physiol 178:1436-1447

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