We offer protocol monitoring services to UNC Investigators in need of an additional layer of oversight.

The NC TraCS Data and Safety Monitoring Board (DSMB) was established to address the needs of local, investigator initiated studies requiring a DSMB. We function as a committee within the UNC School of Medicine. Our charge is to review clinical trials to assure patient safety both by evaluating adverse events and by performing interim analysis of both safety and efficacy.

In general, we will review data from phase III or other trials posing significant risk to subjects. The following types of trials may be reviewed:

• Phase I, I/II, II, and II/III trials when such review is deemed necessary by the UNC IRB and the Principal Investigator
• Phase III and IV clinical trials (single site trials where the PI is a UNC faculty member and for which UNC is the sponsor)
• Select multi-center clinical trials in which UNC is the coordinating center IF the DSMB determines that it has adequate resources to conduct the monitoring required of the study

Please note: the DSMB will set data monitoring and reporting requirements before study enrollment begins and can not provide oversight for studies that have already begun to enroll subjects.

Investigators with commercially or governmentally sponsored trials will normally work with their Sponsor's DSMB. The NC TraCS DSMB is not to be seen or act as surrogate, or substitution, for a Sponsor's responsibility to provide a DSMB when required. Sponsors are to be held to their obligation to provide the relevant oversight as outlined in FDA and NIH policies as applicable.

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