All research studies involving human subjects must have a Data and Safety Monitoring Plan (DSMP). The Translational Research Institute (TRI) can assist investigators with writing DSMPs that are tailored to the complexity and risk of their research studies. Such plans can be included as part of grant applications, study protocols, and IRB submissions. There are several occasions when a formal, independent Data and Safety Monitoring Board (DSMB) may be warranted. DSMBs regularly review accumulating data for ongoing research studies to assess subject safety, scientific validity, and efficacy. TRI can also assist with the organization and implementation of DSMBs for specific research projects. The Food and Drug Administration (FDA) offers a guidance document that provides recommendations on when a DSMB may be required. Individual funding agencies, including the National Institutes of Health (NIH), may also impose additional DSMB requirements. Please check with your funding agency to determine whether they have their own system for oversight or particular requirements.
Elements of a Data and Safety Monitoring Plan
- Risk Assessment. This section of the plan should include adverse event grading (serious vs. non-serious) and attribution (i.e. relationship to investigational product) scales. This section should also assess if the study is minimal risk, greater than minimal risk, or uncertain risk. If greater than minimal risk or uncertain risk, explicit details for managing safety issues that could lead to study interruption and/or termination should be included.
- Monitoring Plan. This section should address who will monitor the study (e.g., principal investigator, members of the investigative team, independent DSMB) and how often the study will be monitored. If the study is being conducted under an investigational new drug (IND) application or investigational device exemption (IDE), the sponsor’s monitoring plans should also be included.
- Interim Study Analysis. This section applies to clinical trials in which clinical implications or safety dictate that the trial should be stopped early if significant positive or negative findings emerge. Plans for interim data analysis should be detailed along with stopping rules, if applicable.
- Reporting Plans. This section should specify how and when adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs) will be reported and to whom (e.g., institutional review board, sponsor, TRI, funding agency, etc).
- Data Accuracy and Protocol Compliance. This section should describe how adherence to the protocol will be assured, how data will be handled and stored, and any security measurements used to protect the data. Confidentiality issues should be addressed as well.
- Conflict of Interest. This section should describe any possible conflicts of interest among the investigator(s) or study team and how these potential conflicts will be managed so that objectivity and subject safety are safeguarded.