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Data and Safety Monitoring Plans


To assure the safety and welfare of subjects all clinical trials at Emory are required to have a data and safety monitoring plan (DSMP). Sponsors often prescribe the DSMP in the protocol. Some clinical trials may have data and safety monitoring boards (DSMB) or committees (DSMC) that are appointed by the sponsor.

Emory IRB Policy and Procedure #49, 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:

  1. Data quality monitoring entity and monitoring frequency (e. g., monitoring visits every 2 months)
  2. Review of data for safety review (e.g., the DSMB convenes every 2 months to review data)
  3. 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, must be addressed immediately.  Your study team should establish a strong and collaborative working relationship with the monitor while on site. 

After the monitoring visit, the PI will need to carefully review the report. The PI should compare old reports to the most recent reports to look for patterns of noncompliance across reports. Patterns of ongoing noncompliance or outstanding issues usually signals problems for the study. Problems should be addressed through root cause analysis and corrective and preventive action (CAPA) plans. Send the CAPA plan to the monitor when responding to the report. Resolve findings promptly and before the next scheduled monitoring visit.

Since 2010, our Emory Institutional Official and Emory Insitutional Review Board rely on CTAC to review monitoring reports in real-time to identify patterns of error and to help investigators respond to monitors, resolve monitoring findings, and promptly report noncompliance to IRBs per policies. Emory requires study teams to send all monitoring reports for all biomedical studies to the Clinical Trials Audit and Compliance listserv within 10 days of receiving the monitoring reports. File the monitoring reports and actions taken in the regulatory binder.   

Self-Assessment

If the study is not being monitored by the sponsor or contract research organization, the PI should consider conducting self-assessments to ensure the protocol is being followed and the data collected are accurate.  Self-assessments can be most successfully 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 Self-Assessment Tool can be used as a checklist and can be customized for each study. The Self-Assessment tool is a REDCap form and will be reviewed by CTAC upon completion.

The FDA regulations require sponsors to monitor trials; thus, if the Emory PI is acting as both a sponsor and investigator (i.e., Sponsor-Investigator), the PI must plan for monitoring. If there is no monitoring provided by the study-supporter, the Sponsor-Investigator 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