This core provides all projects with centralized clinical trial support and provides the infrastructure of personnel and services essential to safely and effectively support such research to meet Good Clinical Practice (GCP) standards. Core services will be provided in Regulatory Affairs, Study Co-ordination, Quality Assurance (QA) and Control (QC) and Data Safety Monitoring (DSM) leveraging the clinical research infrastructure of the Dan L Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including initial and revised submissions to the IRB, IBC, FDA and NIH/ORDA and the subsequent annual reports and adverse event notifications as required. This core has extensive experience with IND submissions, successfully submitting 66 studies of complex biological agents on 32 INDs: the 30 completed studies have enrolled over 600 patients. The Study Co-ordination group arranges meetings of investigators, attending physicians, research nurses and data managers; provides training on the SOPs for each protocol; and offers research nurse support to ensure that clinical studies are conducted safely, accurately and efficiently to GCP standards using the OnCore clinical trials management system. The QC program will ensure that the standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are followed. The QA program will audit each study after the first patient is enrolled; subsequent audits are held in a randomized way to ensure that studies follow Good Clinical Practices. Data Safety monitoring is provided through the DLDCC Data Review Committee operating under an NCI-approved data safety monitoring plan, which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies. Finally the core provides comprehensive and centralized biostatistical support to projects including study design, data analysis and data management for preclinical and clinical studies. Centralized biostatistical support facilitates efficient use of these services and promotes collaboration between biostatisticians and investigators in the design, conduct, analysis and interpretation of results for all projects. This ensures the conduct of high-quality projects that incorporate appropriate and state-of-the-art statistical methods from their design to their analysis.
This core supports the SPORE clinical research studies to ensure they are conducted safely, accurately and in accordance with applicable regulations. It also provides all SPORE projects with statistical support for preclinical experiments and clinical trials.
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