Data and Safety Monitoring (ITHS)

National Institutes of Health (NIH) policy requires that investigators include a general description of the data and safety monitoring plan for clinical investigations (biomedical and behavioral intervention studies) as part of the research application. ITHS requirements for data and safety monitoring are aligned with requirements from NIH and the National Center for Advancing Translational Sciences (NCATS), which supports the ITHS. Assistance with development of DSMPs is best done early in the process of protocol development and at least prior to submission of the Institutional Review Board (IRB) application. The ITHS Regulatory Support and Compliance (RSC) group offers assistance to investigators in developing an appropriate safety monitoring plan for clinical trials involving human subjects. This service is helpful to investigators in determining whether independent medical monitoring (IMM) and/or a data safety monitoring committee (DMC) is necessary for their study. Investigators and study teams may consult RSC to review their protocol and make recommendations as to the appropriate level of monitoring for their study design.