Protocol Review and Monitoring

Vanderbilt University, Nashville TN

Investigators

Linked publications, trials & patents

Abstract

9.2 PROTOCOL REVIEW AND MONITORING SYSTEM Purpose The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of Vanderbilt-lngram 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 that indicates 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 issues, and a justifiable ability to accrue patients. These criteria exist to ensure that the study is conducted in accordance with scientific principles that will allow the scientific aims of the study to be met. This clearly sets the SRC's role apart from the IRB, which primarily concerned with patient safety, while the SRC is focused on sound science designed one day to be translated into better practice. While the SRC and IRB have separate and distinct functions, they complement each other by ensuring the overall integrity of the study from both scientific and patient protection viewpoints. The SRC also assists in determining the level of VICC support for a particular protocol;the IRB has no role in this determination.