Data and Safety Monitoring

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Overview

Data and safety monitoring is used to ensure adherence to the IRB-approved investigative plan, the validity of data collected and most importantly, the safety of those subjects who participate in the project.  A data monitoring plan might be required for projects that involve investigation items/devices or are clinical trials, no matter the risk level. Data and safety monitoring usually occurs with the formation of a Data and Safety Monitoring Board (DSMB). The DSMB is an independent group of experts that advises the principal investigator and if applicable any co-Investigators. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations.

The primary responsibilities of the DSMB are to:

  1. Periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and
  2. Make recommendations to Principal Investigator concerning the continuation, modification, or termination of the trial. The Principal Investigator is responsible for forwarding these recommendations, as well as taking the appropriate actions, to the IRB concerning the continuation, modification, or termination of the trial The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.

Initial IRB Submission Requirements

Where applicable, investigators who will include a DSMB for their project, must also summarize the data monitoring plan in the IRB new study application.  Investigators should have a full plan for data monitoring included in the study records, which may be part of the written protocol or a manual of standard operating procedures.

IRB Reporting Requirements

  • Any Data and safety monitoring or Audit reports must be submitted to the IRB, within two weeks of receipt and sent to an IRB Administrator.
  • Any Data and safety monitoring or Audit reports that identify potential unanticipated problems that involve risks to participants should be submitted to the IRB according to the reportable events policy

Does Your Research Require Data and Safety Monitoring?

Most social/behavioral research projects will not need a separate provision for monitoring the data outside of what’s stated in the IRB-approved Protocol. Pursuant to Federal Regulations of Human Subjects Research, 45 CFR 46.111(a)(6) states the following requirement for IRB approval of human subjects research: "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects." Principal Investigators are advised to take this regulation into consideration and when appropriate, to provide a plan to ensure safety of subjects with details of how data will be monitored.

The NIH Policy for Data and Safety Monitoring states that all NIH funded clinical trials require a Data and Safety Monitoring Plan and that monitoring should be commensurate with risk. Most NIH Institutes/Centers have individual Data and Safety Monitoring policies. Click here for the links to Institute/Center specific policy and guidance.

Does Your Research Require a Data and Safety Monitoring Board?

Data and Safety Monitoring Boards (DSMBs) are specifically required for multi-site clinical trials with interventions that entail risk(s) to participants.

DSMBs are generally required for Phase III clinical trials.

A DSMB may be required for Phase I, Phase II or Phase III clinical trials if any of the following criteria apply:

  • The clinical trial is blinded
  • The clinical trial involves high risk intervention(s)
  • The clinical trial includes vulnerable population(s)

Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials

References

NIH Policies

FDA Policies

Related Policies