Data safety & monitoring
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Plans for Greater than Minimal Risk Research
For research with human subjects meeting the threshold of greater than minimal risk, researchers must provide a plan for monitoring data for safety and indicators that allow for appropriate action and intervention either at the individual level of participation, or in the entire study cohort. The plan is intended to assure researchers can readily address foreseen risks to participants, or identify and manage instances when there may be issues with the study design, interventions or plan that result in unforeseen risks to participants.
Data safety monitoring is required for all clinical trials, but the level, elements and scope of such monitoring vary widely based upon the design, objectives, risks and endpoints of the study. The role of the Institutional Review Board (IRB) is to assess the elements of the plan in the context of the study to ensure the plan is commensurate with trial design and will provide adequate safety to participants.
The data safety monitoring plan is outlined in the research protocol, and the IRB members document their assessment of the adequacy of the plan using reviewer checklists. Elements to be included in the plan are covered below. Factors which the IRB should take into consideration when evaluating the adequacy of plans include the following:
- model of plan chosen (independent committee, monitor, the principle investigator)
- frequency of monitoring and reporting
- expertise of the monitoring entity
- level of risk involved
- types of data to be monitored and reported
This research element falls under criterion 6 in the federal regulations for approval of research with human subjects:
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
Elements of a data safety monitoring plan
- Reporting mechanisms
- The frequency of the monitoring, such as points in time or after a specific number of participants are enrolled
- The entity that will conduct the monitoring, such as a data monitoring committee, data and safety monitoring board, medical monitor, researcher, or independent physician
- The specific data to be monitored
- Procedures for analysis and interpretation of the data
- Actions to be taken upon specific events or end points
- Procedures for communication from the data monitor to the IRB or EC and sites
- Monitoring and reporting of adverse events, including serious events, including the following:
- plan for assessing the seriousness and expectedness of adverse events, including expected adverse events that occur in greater severity or frequency than originally anticipated
- plan for grading adverse events (See Common Terminology Criteria for Adverse Events (CTACAE) Version 4.0 for suggestions for grading adverse events
- plan for determining the relatedness of adverse events (unless determined to be serious)
- plan for reporting to the IRB serious unanticipated adverse events, anticipated adverse events occurring at a greater frequency than expected, and unanticipated problems involving risks to subjects or others at the University or other sites, when applicable for multi-center trials
- plan for reporting unanticipated adverse events and unanticipated problems to co-investigators on the study, and, as appropriate, to the protocol’s research monitors such as DSMB/DSMC, study sponsors, funding and regulatory agencies and regulatory and decision-making bodies