The Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) has developed a robust system for data and safety monitoring, accomplished through the collaborative efforts of the three committees of the Clinical Protocol Scientific Review and Monitoring System (CPSRMS). These committees are: the Scientific Review Committee (SRC), the Data Monitoring Committee (DMC), and the Clinical Trial Audit Committee (CTAC). These committees are responsible for administering the Lurie Cancer Center's Data and Safety Monitoring Plan (DSMP), which was originally approved by the NCI in August of 2001, and has since undergone 10 revisions. The most recent revision to the plan was submitted to the NCI in May of 2012 and was accepted without comment at that time. In the previous competing CCSG application the assessment of Data and Safety Monitoring resulted in an Acceptable [Approved] status with no deficiencies noted. However, in section 9.2 PRMS, the previous CCSG competing submission included comments in the critique that relate directly to data and safety monitoring. First, it was suggested that the CTAC expand the auditing program to be more comprehensive. This has been done, and the audit strategy is described below. The second comment relates to DMC review for phase I studies and offered that a medical monitor may provide greater oversight for these trials if our phase I studies increase in number. A significant increase has not been seen, so this change has not been made, however both the SRC and DMC are mindful of and appreciate this recommendation. If our phase I program increases substantially, this change will be considered.
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