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 #
3P30CA091842-11S1
Application #
8530580
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
$2,777
Indirect Cost
$950

  Institution

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

  Publications

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 :
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
Miller, Christopher A; Tricarico, Christopher; Skidmore, Zachary L et al. (2018) A case of acute myeloid leukemia with promyelocytic features characterized by expression of a novel RARG-CPSF6 fusion. Blood Adv 2:1295-1299
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
Jeong, Mira; Park, Hyun Jung; Celik, Hamza et al. (2018) Loss of Dnmt3a Immortalizes Hematopoietic Stem Cells In Vivo. Cell Rep 23:1-10
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
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
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

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