NINDS requires that each trial it supports, regardless of phase, have data and safety monitoring procedures in place to safeguard the well-being of study participants and to ensure the trial's scientific integrity. As an aid in preparing the budget section of the PI's grant application, this document provides guidelines for budgeting for these activities which may involve utilizing an independent medical safety monitor, a safety monitoring committee, or a data and safety monitoring board. For additional information see NINDS Guidelines for Data and Safety Monitoring in Clinical Trials.
Independent Medical Safety Monitor - roles and responsibilities will vary depending on the study. The cost estimate for the IMM will depend on the expected recruitment/enrollment rate, number of AE/SAEs anticipated, and other criteria that may impact the time commitment and level of review required (e.g., frequency of review, or expected number of AE/SAEs). For budgeting purposes, include the cost of compensating the IMM (based on a small percent effort or an estimated total number of hours) and the cost of preparing and transmitting materials and reports.
Safety Monitoring Committee- the SMC is an independent monitoring committee appointed by and reporting to the PI. The budget for this activity will depend on the number of members, the frequency of meetings (generally 2 a year), and the complexity of the study and AE/SAEs expected. Allow for compensation for committee members, travel to meetings, and the cost of preparing and transmitting materials and reports.
Data and Safety Monitoring Board - the DSMB is appointed by and reports to the NINDS. Usually the DSMB meets twice a year, once in person and once via telephone conference call; the frequency and type of meeting will be determined by the DSMB. Since NINDS appoints the DSMB, reimbursement for travel and honorarium for DSMB members are paid for by the NINDS and not from the grant budget. The grant budget should include compensation for the statistical analysis and for the preparation and delivery of the DSMB report and travel to DSMB meetings for the study PI, study statistician, and medical safety monitor (in addition, other study personnel, such as the clinical coordinator may provide useful insight to the DSMB). When estimating travel, assume meetings will be held in the Washington, D.C. area. Along with the DSMB related costs, compensation for a medical safety monitor, who will review SAEs in real time, should be included.
Last updated April 25, 2013