Data Safety Monitoring Board

The Wake Forest NCORP Research Base Data Safety Monitoring Board meets every six months to review Wake Forest NCORP Research Base protocols.  The Board includes members demonstrating experience and expertise in oncology, biological sciences, biostatistics and ethics.

The DSMB reviews accrual information and interim analyses of outcome data and cumulative toxicity data summaries to determine whether:

• The trial should continue as originally designed
• The trial should be changed
• The trial should be terminated
• Outcome results should be released prior to the reporting of the study results

Members of this committee as well as the organization statistician will oversee the safety monitoring of the study to ensure that the privacy of all participants in the study is protected; ensure that participants’ interests are primary, that is, above the interests of the scientific investigation; and to ensure that all data collection is scrutinized for accuracy, privacy, and levels of protection. Reports of all DSMB meetings and recommendations will be provided to the NCI, CIRB, WF NCORP RB, and participating sites, as requested.