The UNC Lineberger Comprehensive Cancer Center is committed to the safety of patients participating in clinical trials. The UNC Lineberger is also committed to protocol compliance and data accuracy. In support of these commitments, the Cancer Center has established and implemented an institutional Data and Safety Monitoring Plan to assure data and safety monitoring for Cancer Center clinical trials. The National Cancer Institute reviewed and approved this plan in 2001. The Center has also established the Oncology Protocol Audit Committee and process to review UNC LCCC institutional clinical trials. The Data and Safety Monitoring Committee (DSMC), led by Dr. Mark Socinski, is the primary agent for data and safety monitoring. The Committee, which meets monthly, has oversight for all oncology clinical trials conducted in association with the UNC Lineberger. The DSMC reports findings to the Protocol Review Committee, which reviews and forwards these reports and makes recommendations to the UNC Chapel Hill School of Medicine's Committee for the Protection of the Rights of Human Subjects (SOM-IRB) and to the School's Data and Safety Monitoring Board (SOM-DSMB). The level of data and safety monitoring for a trial depends upon the risk to the patients and the complexity of the trial. The Oncology Protocol Audit Committee (OPAC) audits institutional clinical trials for data accuracy and completeness. Dr. Lisa Carey, a medical oncologist, chairs the Committee. All institutional clinical trials with ongoing accrual are audited once per year following their initial IRB approval anniversary. Audits are held four times a year (December, March, June, and September) and conducted by Cancer Center members from disease groups different than the protocols being audited. Audit findings are submitted to OPAC, which determines ratings and actions and reports to the Protocol Review Committee and to the Principal Investigators. The PRC reports substantial and/or serious protocol deviations to the UNC Lineberger Associate Director for Clinical Research, the UNC Lineberger Director, the SOM-IRB, and to the trial sponsors.
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