Data & Safety Monitoring

One of the regulatory criteria for IRB approval is that the research provides adequate provisions for monitoring data to ensure safety of subjects and research integrity. The information below provides a description of data and safety monitoring and outlines the IRB requirements for each.

Data Monitoring

Data monitoring is used to ensure both adherence to the approved investigative plan and the validity of data collected.1 A data monitoring plan is required for all studies, no matter the risk level. 

Elements of a Data Monitoring Plan

• Who is responsible for performing the data monitoring?
• How often will monitoring be performed?
• What components of the study will be monitored?
• How will monitoring be documented and responded to appropriately?

For additional details go to:

• Elements of a Data Monitoring Plan [PDF]
• Investigator Self-Assessment Checklists

Initial IRB Submission Requirements

Investigators must 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 protocol, a manual of operations, or a study SOP.

IRB Reporting Requirements

• Data monitoring/audit reports that identify deviations should be submitted to the IRB according to the deviation reporting policy .
• Data monitoring/audit reports that identify potential unanticipated problems that involve risks to participants should be submitted to the IRB according to the unanticipated problems policy .
• Data monitoring/audit reports that identify no deviations or problems do not need to be submitted to the IRB.  If you would like to submit these reports, you may do so via the Report Form , indicating "Information" as the report type.

Safety Monitoring

Safety monitoring can be defined as the observations required to minimize threats to the safety and welfare of research subjects.1 In order to monitor safety, the study team must also monitor the data collected, such that an accurate recording of all adverse events and other applicable data elements can be reviewed for safety purposes.  For this reason, the data and safety monitoring plan may be combined for some studies.

A safety monitoring plan is required for all studies that are greater than minimal risk, as determined by the IRB.  According to NIH policy, a Data and Safety Monitoring Board (DSMB) is a required safety monitoring element for all phase III clinical trials funded through the NIH.  The investigator is responsible for considering whether the study risks warrant establishment of a DSMB.  The IRB may also require a DSMB if the study risks so warrant.

Elements of a Safety Monitoring Plan

• Who is responsible for performing the safety monitoring?
  • Is a Data and Safety Monitoring Board (DSMB) appropriate?
  • Is the monitoring entity internal to the study or independent from the study team?
• How often will monitoring be performed?
• What components of the study will be monitored for safety purposes?
  • Study accrual rate
  • Compliance with eligibility criteria
  • Participant adherence with assigned therapy, intervention, or study procedures
  • Investigator adherence with the approved protocol and investigative plan
  • Adverse events and other problems or trends that may indicate a safety concern for participants
  • Interim analysis to determine if the study will be able to answer the study hypotheses or meet study aims
• How will monitoring be documented and responded to appropriately?

For additional details go to:

• Elements of a Safety Monitoring Plan [PDF]
• For considerations for use of a Data and Safety Monitoring Board, we recommend the following source materials:
  • Data Monitoring Committees in Clinical Trials, A Practical Perspective. Written by Susan S. Ellenberg, Thomas R. Flemming, and David L. DeMets

Initial IRB Submission Requirements

Investigators must summarize the safety monitoring plan in the IRB new study application.  Investigators should have a full plan for safety monitoring included in the study records, which may be part of the protocol, a manual of operations, or a study SOP.

IRB Reporting Requirements

• Safety monitoring reports (which include DSMB reports) that identify potential unanticipated problems involving risks to participants should be submitted to the IRB according to the unanticipated problems policy .
• Safety monitoring reports (which include DSMB reports) that identify no problems must be submitted to the IRB within 90 days. This may be done via the Report Form, indicating "Information" as the report type; or if a continuing review application is due within 90 days, it may be included in the continuing review application. 
• If the study uses a DSMB, the most recent DSMB report must be provided in the IRB continuing review application.

References:

• White S, Field L, Wolf D. Monitoring the Monitors. Applied Clinical Trials. September 2007; p52-60