Clinical Trials Office Quality Review
The Scientific Review Committee (SRC) is charged with conducting a scientific review of all protocols to be executed under the auspices of the Vanderbilt-Ingram Cancer Center and which use Cancer Center resources.
To help ensure optimal protocol performance, a tripartite quality assurance program has been developed which includes:
preactivation protocol review;
active clinical trials review; and
adverse event and regulatory review.
The quality assurance efforts are coordinated through the CTO. However, the membership of those committees responsible for quality review are diverse and include representatives from many disciplines and departments, thus, insuring an un-biased and thorough review. The goals of quality review are:
to ensure that all protocols undergo scientific and ethical review prior to initiation;
to ensure that all protocols meet Federal and local regulatory guidelines prior to initiation;
to review clinical trial operations to ensure appropriate and timely execution of protocols;
to systematically review adverse events to ensure that consent forms reflect the risk and benefits of therapy; and
to review regulatory documents on a routine basis to ensure ongoing compliance.
In addition the Vanderbilt-Ingram Cancer Center has an approved Data Safety and Monitoring Plan (DSMP)*. The DSMC provides centralized review of adverse drug events and safety issues for investigator-initiated trials and NCI-funded trials. The DSMC is also charged with auditing institutional trials to ensure that the conduct and integrity of the study are of the highest quality and that all trials adhere to the regulatory requirements. Thus, all therapeutic and device investigator-initiated and NIH/NCI-funded clinical trials are monitored for scientific progress, accrual, data completeness, and regulatory compliance.
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