The Data and Safety Monitoring Program (DSMP) has been reviewed and approved by the UAB IRB and the NCI. It provides procedures for rigorous monitoring of all Cancer Center therapeutic clinical trials consistent with national and institutional guidelines. It utilizes three Cancer Center entities in addition to the UAB IRB - (1) the Clinical Trial Monitoring Committee (CTMC), (2) the Quality Assurance Committee (QAC), and (3) the Clinical Trial Network and Monitoring (CTNM) Office. The CTMC meets weekly to rigorously review patient data and safety by specific disease sites so that each clinical trial has oversight at least monthly with documentation of review and reports to the QAC (e.g. breast and melanoma - first Friday;Gl and GU - second Friday, etc.). The QAC meets monthly and reviews CTMC reports and reports of QAC internal audits on investigator-initiated trials not otherwise audited. These internal QAC audits average 24/year. The CTNM Office provides investigators with the capacity for IND held and/or multi-institutional trials. It provides the """"""""sponsor"""""""" responsibilities including source document verification, monitoring, and FD/VIRB reporting as well as multi-site coordination and oversight. The DSMP of the Cancer Center provides assurance of the quality and safety of clinical trials for patient participants and clinical investigators according to federal and institutional guidelines.
The Data Safety and Monitoring Program is a critical component to coordinating high quality clinical and translational research. Thus, this program is extremely relevant to a primary mission of the Cancer Center.
|Kim, H-G; LeGrand, J; Swindle, C S et al. (2017) The assembly competence domain is essential for inv(16)-associated acute myeloid leukemia. Leukemia 31:2267-2271|
|Miller, Aubrey L; Garcia, Patrick L; Pressey, Joseph G et al. (2017) Whole exome sequencing identified sixty-five coding mutations in four neuroblastoma tumors. Sci Rep 7:17787|
|Childers, Noel K; Grenett, Hernan; Morrow, Casey et al. (2017) Potential Risk for Localized Aggressive Periodontitis in African American Preadolescent Children. Pediatr Dent 39:294-298|
|Kasten, Benjamin B; Arend, Rebecca C; Katre, Ashwini A et al. (2017) B7-H3-targeted 212Pb radioimmunotherapy of ovarian cancer in preclinical models. Nucl Med Biol 47:23-30|
|Prince, Andrew C; Jani, Aditi; Korb, Melissa et al. (2017) Characterizing the detection threshold for optical imaging in surgical oncology. J Surg Oncol 116:898-906|
|McConnell, Matthew; Feng, Shengmei; Chen, Wei et al. (2017) Osteoclast proton pump regulator Atp6v1c1 enhances breast cancer growth by activating the mTORC1 pathway and bone metastasis by increasing V-ATPase activity. Oncotarget 8:47675-47690|
|Kumar, Ranjit; Yi, Nengjun; Zhi, Degui et al. (2017) Identification of donor microbe species that colonize and persist long term in the recipient after fecal transplant for recurrent Clostridium difficile. NPJ Biofilms Microbiomes 3:12|
|Van Beusecum, J P; Zhang, S; Cook, A K et al. (2017) Acute toll-like receptor 4 activation impairs rat renal microvascular autoregulatory behaviour. Acta Physiol (Oxf) 221:204-220|
|Ghosh, Arindam P; Willey, Christopher D; Anderson, Joshua C et al. (2017) Kinomic profiling identifies focal adhesion kinase 1 as a therapeutic target in advanced clear cell renal cell carcinoma. Oncotarget 8:29220-29232|
|Shah, Spandan; Gibson, Andrew W; Ji, Chuanyi et al. (2017) Regulation of FcR? function by site-specific serine phosphorylation. J Leukoc Biol 101:421-428|
Showing the most recent 10 out of 692 publications