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. Core services will be provided in regulatory affairs, study co-ordination, quality assurance and control and data safety monitoring. 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. This core has extensive experience with IND submissions, successfully submitting 48 studies of complex biologies, under 27 INDs during the past 10 years;the 20 completed studies have enrolled over 400 patients. The core arranges group meetings of investigators, attending physicians, research nurse, data managers, to provide training on the SOPs for each protocol and provides research nurse support to ensure that clinical studies are conducted safely, accurately and efficiently The Quality Control (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. The core will also co-ordinate data mohitoring with the SPORE Data Review Committee which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies. . Finally, the core accessions follow up samples from patients on clinical trials and enter details into a database in the Good Laboratory Practice (GLP) Laboratory, allowing subsequent follow up testing including flow cytometry in a CLIA certified laboratory.
This core supports the SPORE clinical research studies to ensure they are conducted safely, accijrately and in accordance with applicable regulations. The Core also monitors study outcomes and processes and logs follow up samples allowing evaluation of study outcomes.
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