Data and Safety Monitoring

点击翻译按钮获取中文摘要

PROJECT SUMMARY (See instructions): Data and Safety Monitoring The Data and Safety Monitoring Committee (DSMC) provides rigorous review of all industry and institutional protocols at the HCCC. More specifically, the primary duties of the DSMC are to: ¿ prospectively screen all patients entering HCCC investigator-initiated trials for trial-specified eligibility. The study coordinator delivers a completed eligibility checklist, with test results, to the safety officer, who verifies that the inclusion and exclusion criteria are met. Questions or concerns about eligibility are discussed with the DSMC chair and/or the Study Monitor. The safety officer then communicates DSMC approval, questions or concerns to the research team before the subject is enrolled in the trial. ¿ assess safety by reviewing all severe adverse events and ensure timely and appropriate reporting to oversight agencies (e.g. NCI, FDA, IRB) ¿ conduct audits of selected trials for data veracity, protocol adherence, and subject safety based on overall HCCC Data and Safety Monitoring Plan and the risk level of the study. The DSMC has the authority to close a clinical trial by contacting the IRB should safety issues warrant such closure.