Data Monitoring
Special Plans
Researchers must develop and implement plans to monitor data for safety of participants. For example, research in which reports of serious harms are expected require a plan for monitoring the data collected from or about participants. The monitoring plan must evaluate the incidence and severity of expected harms to verify whether or not they match those that were expected at the initiation of the research. In addition, researchers must evaluate the causality of unexpected harms.
Review
Ongoing monitoring of research, which may be completed by researchers or independent boards, occurs at expected and planned time points, as well as at the time one becomes aware of an unexpected harm.
Scale
The monitoring plan should correspond to the probability and magnitude of harm to participants. Some larger scale studies that include use of investigational products require a robust mechanism for monitoring that will be verified by the IRB.
Although the following list is not exhaustive, it is intended to provide an example of monitoring required for each level of review:
- Low and minimal risk research: Periodic, internal review of data. Annual continuing
review by IRB
- High risk research: Independent, quarterly review by DSMB. Semi-annual continuing review by IRB
Examples
If your study includes a large study populations, multiple study sites, highly toxic therapies, high expected rates of mortality, or high probability of early termination, a Data Safety Monitoring Board will likely be required.
Resources
Refer to the following web site for additional resources and information regarding Data Safety Monitoring.
Yes. Investigator initiated investigational trials require special safety monitoring considerations prior to IRB approval. Refer to the following link for additional guidance regarding investigator initiated new drug or device guidelines.
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