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

Copper, Tara Conway; Jeffe, Donna B; Ahmad, Fahd A et al. (2018) Emergency Information Forms for Children With Medical Complexity: A Qualitative Study. Pediatr Emerg Care :
Stephens, Calvin J; Kashentseva, Elena; Everett, William et al. (2018) Targeted in vivo knock-in of human alpha-1-antitrypsin cDNA using adenoviral delivery of CRISPR/Cas9. Gene Ther 25:139-156
Trissal, Maria C; Wong, Terrence N; Yao, Juo-Chin et al. (2018) MIR142 Loss-of-Function Mutations Derepress ASH1L to Increase HOXA Gene Expression and Promote Leukemogenesis. Cancer Res 78:3510-3521
Liu, Ying; Colditz, Graham A; Rosner, Bernard A et al. (2018) Comparison of Performance Between a Short Categorized Lifestyle Exposure-based Colon Cancer Risk Prediction Tool and a Model Using Continuous Measures. Cancer Prev Res (Phila) 11:841-848
McGill, Bryan E; Barve, Ruteja A; Maloney, Susan E et al. (2018) Abnormal Microglia and Enhanced Inflammation-Related Gene Transcription in Mice with Conditional Deletion of Ctcf in Camk2a-Cre-Expressing Neurons. J Neurosci 38:200-219
Sharma, Piyush K; Dmitriev, Igor P; Kashentseva, Elena A et al. (2018) Development of an adenovirus vector vaccine platform for targeting dendritic cells. Cancer Gene Ther 25:27-38
Garbow, Joel R; Tsien, Christina I; Beeman, Scott C (2018) Preclinical MRI: Studies of the irradiated brain. J Magn Reson 292:73-81
Dodson, Elizabeth A; Hipp, J Aaron; Lee, Jung Ae et al. (2018) Does Availability of Worksite Supports for Physical Activity Differ by Industry and Occupation? Am J Health Promot 32:517-526
Bauerle, Kevin T; Hutson, Irina; Scheller, Erica L et al. (2018) Glucocorticoid Receptor Signaling Is Not Required for In Vivo Adipogenesis. Endocrinology 159:2050-2061
Guggisberg, Ann M; Frasse, Philip M; Jezewski, Andrew J et al. (2018) Suppression of Drug Resistance Reveals a Genetic Mechanism of Metabolic Plasticity in Malaria Parasites. MBio 9:

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