CORE 016: PROTOCOL REVIEW & MONITORING SYSTEM/SCIENTIFIC REVIEW COMMITTEE PROTOCOL SUMMARY/ABSTRACT The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of Vanderbilt-Ingram Cancer Center (VICC) meet the committee?s pre-defined standards of scientific design. The Committee is also responsible for assigning a priority score for each protocol. This score generally guides the amount of Cancer Center support a particular protocol should receive. Protocols requiring full committee review are evaluated for appropriate scientific rationale, clearly defined specific aims, achievable study endpoints, a plausible biostatistical plan, feasibility, and a justified ability to accrue eligible patients. These criteria exist in order to ensure that the study is conducted in accordance with scientific principles that will allow for the aims of the study to be met. This clearly sets the SRC?s role apart from the IRB, in that the IRB is primarily concerned with patient safety, while the SRC is focused on sound science with potential to translation to cancer care. The SRC and IRB have two separate functions and yet both complement each other by ensuring the integrity of the study through a sound scientific approach while also giving consideration to the protection of all participants. The IRB has no role in determining the extent of Cancer Center support that a particular protocol should receive. In addition to ensuring a high level of scientific merit and appropriate prioritization of VICC trials, the SRC oversees the progress of all active clinical trials by routinely monitoring the accrual to all Cancer Center protocols and closing studies that do not demonstrate scientific progress and adequate accrual. Low accruing studies involving rare diseases and studies that meet the Cancer Center?s mission for personalized medicine with targeted therapies will be given special consideration. The SRC will review any protocol changes that have a significant impact on the design or scientific rationale for the clinical trial.
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