Data and Safety Monitoring

$157,118P30FY2013CANIH

Vanderbilt University, Nashville TN

Investigators

Linked publications & trials

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Abstract

Purpose The Vanderbilt-lngram Cancer Center (VICC) oversees patient safety and data monitoring for its investigator-initiated and NIH-NCl funded clinical trials through its Data and Safety Monitoring Committee (DSMC). The purpose of the DSMC is to ensure the efficient implementation and management of the VICC Data and Safety Monitoring Plan (DSMP). The Committee maintains authority to intervene in the conduct of studies as necessary to ensure clinical research performed at VICC achieves the highest quality standards. Data and Safety Monitoring Plan The DSMP is accessible to all VICC investigators through the VICC website. The plan scope addresses the following: ¿ Proper monitoring of trial progress and the safety of clinical trial participants ¿ Compliance with requirements regarding the reporting of adverse events as per institutional and federal guidelines ¿ Scope of temporary or permanent suspension of an NCI-funded clinical trial ¿ Data accuracy and protocol compliance VICC's plan is approved by the NCI Data and Safety Monitoring Review Panel as well as the Vanderbilt University Medical Center Institutional Review Board.

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