Brief Overview

All interventional studies involving more than minimal risk must include a Data and Safety Monitoring Plan (DSMP).  A DSMP is established to assure that each research study has a system for appropriate oversight and monitoring of the conduct of the study to ensure the safety of participants and the validity and integrity of the data.  The DSMP should specify whether or not there will be an independent Data and Safety Monitoring Board (DSMB).

The primary purpose of an independent DSMB is to protect the research subjects through independent analysis of emerging data from the trial.  This differs from adverse event reporting in that the DSMB can review aggregate and unblinded data as the data accumulate, identify significant issues and trends during the study, and recommend changes in the study including recommending early termination of the study.  The DSMB reviews data for both safety and efficacy.  The protections afforded by this review apply to both current subjects and future subjects if the DSMB identifies the need to modify or even halt the trial. In addition, an independent DSMB protects the credibility of the trial by virtue of its independence from the study sponsors, and helps to ensure the validity of study results by reviewing data on subject accrual and conducting interim reviews.

Purpose of the SOM DSMB

The UNC School of Medicine Data and Safety Monitoring Board (SOM DSMB) has been established to address the needs of local, investigator initiated studies requiring a DSMB. The SOM DSMB functions as a committee within the UNC School of Medicine. The charge to the SOM DSMB is to review clinical trials to assure patient safety both by evaluating adverse events and by performing interim analyses of both safety and efficacy.

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Types of Studies Reviewed by the SOM DSMB

The SOM DSMB is responsible for reviewing data from investigator initiated clinical trials approved by the UNC IRB. In general, the SOM DSMB will review data from phase III or other trials posing significant risk to subjects. The following types of trials may be reviewed by the SOM DSMB:

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

Investigators with commercially or governmentally sponsored trials will normally work with their Sponsor’s DSMB. The SOM DSMB is not to be seen or act as surrogate, or substitution, for a Sponsors 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.