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Data and Safety Monitoring Plans

To assure the safety and welfare of participants, all greater than minimal risk clinical trials at Emory are required to have a data and safety monitoring plan (DSMP).  Sponsors include the DSMP in the protocol.  Some clinical trials may have data and safety monitoring boards (DSMB) or committees (DSMC)  appointed by the sponsor or investigator. 

Emory IRB Policy and Procedure #50, Data and Safety Monitoring Plans, describes the required components of a DSMP. The Emory IRB also provides guidance on how to write a DSMP.

Compliance with the DSMP

The DSMP should define the following:

  • Data quality monitoring entity and monitoring frequency (e. g., monitoring visits every 2 months)
  • Review of data for safety review (e.g., the DSMB convenes every 2 months to review data)
  • Collection, reporting, and review of adverse events

It is the responsibility of the sponsor to provide the monitoring that was agreed upon at the start of the study. It is the PI’s responsibility to ensure that the DSMP, as approved by the IRB, is being followed.

Monitoring

Sponsors are required to secure compliance when noncompliance is found. Deviations noted in monitoring reports are often findings of noncompliance (with the protocol requirements or federal regulations) and thus, should be addressed promptly.  Study teams should establish a collaborative working relationship with study monitors.  

After the monitoring visit, the monitor will send the study team a written report of findings.  The PI and study team should carefully review the report and assign tasks.  Compare old reports to the most recent reports to look for patterns of noncompliance across reports. Send all monitoring and other quality assurance reports to the Clinical Trials Audit and Compliance listserv at ctcompliance@emory.edu within 10 days of receipt.  File the monitoring reports and actions taken in the regulatory binder. 

Self-Assessments

If the study is not being monitored by the sponsor or contract research organization, the PI should consider performing self-assessments. Self-assessments are best implemented by someone within the clinical department that is not directly involved with the data collection or entry.  Clinical departments are urged to use a buddy system whereby research coordinators or nurses switch off studies to review at least twice per year. The Emory University Self Assessment Tool can be used. Self-assessments may be part of an IRB-approved DSMP for moderate and high complexity category B studies as defined by the Emory IRB. The Emory IRB does not allow self-assessments for high-complexity studies (Phase I, II, and III under an IND/IDE, high risk due to procedures involved or trials comparing two or more standard of care interventions for comparative effectiveness). Emory investigators acting as both sponsor and investigator (Sponsor-Investigators) must obtain monitoring through a contract research organization.

Sponsor-Investigators over a multi-site study may require the sites to perform self-assessments along with periodic collection of protocol deviation forms, to ensure compliance across all sites.

References

IRB Policies and Procedures and NIH Policy on Data and Safety Monitoring