Data Safety and Monitoring

$203,966P30FY2014CANIH

University Of Alabama At Birmingham, Birmingham AL

Investigators

Linked publications & trials

Paper 39713459 Paper 39642329 Paper 39604120 Paper 39553825 Paper 39489766 Paper 39464096 Paper 39386666 Paper 39377264 Paper 39361227 Paper 39323387 Paper 39255453 Paper 39240686 Paper 39218899 Paper 39199623 Paper 39149492 Paper 38956234 Paper 38948780 Paper 38935616 Paper 38918836 Paper 38867704 Paper 38849476 Paper 38824070 Paper 38772123 Paper 38766241 Paper 38743486 Paper 38570263 Paper 38539515 Paper 38530365 Paper 38518528 Paper 38467087 Paper 38451522 Paper 38277493 Paper 38262310 Paper 38250045 Paper 38241154 Paper 38154167 Paper 38150547 Paper 38150142 Paper 38135177 Paper 38114543 Paper 38106208 Paper 38086808 Paper 38068776 Paper 38039923 Paper 38011564 Paper 37946177 Paper 37931781 Paper 37919169 Paper 37895177 Paper 37892669 Paper 37850446 Paper 37782053 Paper 37776872 Paper 37717172 Paper 37660914 Paper 37643018 Paper 37640572 Paper 37626587 Paper 37578272 Paper 37552575 Paper 37495106 Paper 37483698 Paper 37479754 Paper 37428799 Paper 37398342 Paper 37398202 Paper 37384638 Paper 37382447 Paper 37380890 Paper 37365848 Paper 37345044 Paper 37327322 Paper 37287117 Paper 37246417 Paper 37240357 Paper 37226942 Paper 37192295 Paper 37177979 Paper 37142223 Paper 37067340 Paper 37058110 Paper 37046795 Paper 37046042 Paper 37034637 Paper 37014961 Paper 36968227 Paper 36958335 Paper 36926842 Paper 36922679 Paper 36907775 Paper 36904284 Paper 36900368 Paper 36882605 Paper 36865329 Paper 36775449 Paper 36735117 Paper 36724083 Paper 36711885 Paper 36711747 Paper 36697463

Abstract

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.

View original record on NIH RePORTER →