The NCI guidelines set forth requirements for DSMC/B composition and function; note that it is required that a majority of the members be drawn from outside the institution conducting the study. Membership is usually comprised of experts in the fields of medicine and science that are applicable to the study, statistical experts, lay representatives, and others who can offer an unbiased assessment of the study progress.
The DSMC/B should ensure that important safety information get to the IRB in a timely manner: "The study leadership will provide information on cumulative toxicities and relevant recommendations to the local principal investigators, to be shared with their IRBs."
The MCW/Froedtert Hospital IRB follows guidelines set out by the National Cancer Institute (NCI), as they are the most comprehensive of the NIH guidelines. The NIH (NCI model) says that "All clinical trials supported or performed by NCI require some form of monitoring. "Risk and complexity are identified as the most important determinants of the degree and method of monitoring.
Early studies (non-therapeutic, Phase I, Phase II) are allowed great flexibility in monitoring; it is specifically allowed that the PI do the monitoring. However, the policy requires written policies and procedures, and also requires that "regardless of the method used, monitoring must be performed on a regular basis."
All Phase-III studies require a formal DSM plan, which may mean the establishment of a Data Safety Monitoring Board (DSMB) at the sponsoring institute or at the study site or at the lead institution of a multi-center trial. Note: Low-risk behavioral and nutritional trials may not require a DSMB.