Data and Safety Monitoring

One of the regulatory criteria for IRB approval is that the research provides adequate provisions for monitoring data to ensure safety of participants and research integrity. The information below provides a description of data and safety monitoring plans (DSMP) and data and safety monitoring boards (DSMB).

What is a Data and Safety Monitoring Plan (DSMP)?
What is clinical trial monitoring?
What is included in a Data and Safety Monitoring Plan (DSMP)?
Who might monitor data?
Who might monitor for safety?
What is a Data and Safety Monitoring Board (DSMB)?
Do the regulations require DSMBs?
What are the responsibilities of a DSMB?
What must be submitted to the IRB regarding a DSMP or DSMB?


What is a data and safety monitoring plan?

A data and safety monitoring plan (DSMP) is meant to assure that each clinical investigation has a system for oversight and monitoring of the conduct of the clinical investigation. This oversight is intended to ensure the safety of the participants and the validity and integrity of the data. A DSMP should be commensurate with the risks. A DSMP can be as simple as the investigator reporting adverse event information to the IRB or as complex as having a Data and Safety Monitoring Board.

What is clinical trial monitoring?

A DSMP often includes clinical trial monitoring. Clinical trial monitoring refers to the methods used to oversee the conduct of, and reporting of data from, clinical investigations including appropriate clinical investigator supervision of study site staff. Monitoring activities include communication with the investigator and the study site staff; review of the study site’s processes, procedures, and records; and verification of the accuracy of the data.

What is included in a DSMP?

A DSMP should include processes for handling the following (as applicable):

1. Monitoring the Progress and Safety of the Trial

  • What are the potential risks and benefits for study participants?

  • What is the screening process and how it will be used to protect participants?

  • What are the measures to protect participants against risk?

  • Who will monitor the trials, what type of information will be reviewed, what are the parameters for defining abnormal values and what is the periodicity of review?

  • What are the stopping rules for the study?

  • What procedures are in place for multicenter trials, if applicable?

  • How will conflict of interest, or the perception of a conflict, be managed?

2. Reporting of Unanticipated Problems (UPs)

  • What constitutes a UP (include a definition, grading scale, and “study relatedness” criteria)?

  • What is the process for assuring that UPs are reported appropriately?

  • What are the timelines for UP collection and reporting?

3. Reporting of Suspensions or Terminations

  • Which actions (FDA, Sponsor, IRB, etc.) will be reported and who insures these actions are reported appropriately?

4. Assuring Data Accuracy and Protocol Compliance

  • How are data accuracy and protocol compliance assured?

  • What are the procedures to assure protocol adherence (i.e., protocol compliance checks, external data-audits, regular data verification, etc.)?

  • How are protocol deviations reported?

  • How is noncompliance reported?

Who might monitor data?

In addition to the principal investigator, there may be other data monitoring entities responsible for the DSMP. This can include:

  • Data coordinating center or project principal investigator (for multi-site studies)

  • Commercial sponsor or contract research organization

Who might monitor for safety?

In addition to the principal investigator, there may be other safety monitoring entities responsible for the DSMP. This can include:

  • Data safety monitoring board (DSMB)

  • Medical monitor

  • Cancer Center Data Safety Monitoring Council

What is a Data and Safety Monitoring Board (DSMB)?

A Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises the study investigators. The DSMB reviews data for both safety and efficacy. The protections afforded by this review apply to both current and future research participants if the DSMB identifies the need to modify or even halt the trial. Primary responsibilities of a DSMB are to:

  • Periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and

  • Make recommendations 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.

Do the regulations require DSMBs?

The regulations provide minimal insight on DSMBs. The Code of Federal Regulations indirectly addresses data safety monitoring in 45CFR 46.111 (a)(6) which states “When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.” The 2006 FDA guidance document discusses the roles, responsibilities, and operating procedures. This document is helpful in determining whether it is needed and how it should function. Some government agencies that sponsor clinical research have required the use of a DSMB in certain clinical trials. Current FDA regulations, however, impose no requirements for the use in trials except under 21 CFR 50.24(a)(7)(iv) for research studies in emergency settings in which the informed consent requirement is excepted. Though it is not required, the FDA generally expects the use of DSMBs for randomized trials with mortality or major morbidity as primary endpoints.

What are the responsibilities of a DSMB?

The primary responsibility of the DSMB is to safeguard the interest of study participants. Therefore, the DSMB must approve the safety measures in the protocol to preserve the study credibility and facilitate the availability of timely and reliable findings to the broader clinical community. In addition, the DSMB should:

  • Provide written documentation confirming review of the protocol and agreement with the study design and the data safety monitoring plan (DSMP)

  • Review the progress of the study carefully and diligently. The DSMB should assure that all significant adverse events are reported to the IRB according to policies and procedures

  • Be available to the investigator for consultation concerning any adverse study events

  • Consider the impact of newly published findings bearing on the safety profile of the study

  • Provide written reports to be shared with the IRB which summarizes oversight activities and recommendations, and any concerns regarding subject safety

What must be submitted to the Institutional Review Board regarding the DSMP or DSMB?

Principal investigators must provide information about the DSMP and if applicable, the DSMB in the initial IRB application (Section 12 of the Biomedical IRB application).

DSMB specific requirements
When established, the list of the DSMB members, including their affiliation and credentials and the DSMB charter, must be submitted to the IRB. Brown University provides a DSMB charter template which can be accessed from the forms and templates section of the HRPP webpage.  The DSMB charter defines the responsibilities for the study principal investigator and DSMB members and sets guidelines for the conduct of DSMB meetings. The Charter is intended to be a living document.  The DSMB may wish to review it at regular intervals to determine whether any changes in procedure are needed.A description of the DSMB must be provided with the application. The DSMB reports should be provided to the IRB as they are received.

Additional Resources: