Office of Research Integrity
Transforming tomorrow by Promoting Ethical Research

Resources for Data and Safety Monitoring

Monitoring the progress of the research and the safety of participants are key components to a Data and Safety Monitoring Plan (DSMP).  If you are conducting a clinical investigation, you should have an established DSMP.  
Guidance for Developing a Data and Safety Monitoring Plan (DSMP) for your Research Proposal

Including the following components, and describe the essential elements of each component:

  1. Monitoring the progress of clinical investigations and the safety of participants:
    • procedures for promptly detecting harm and mitigating potential injuries;
    • who actually implements monitoring procedures and how often;
    • what the monitors look for;
    • procedures to ensure adequate feedback of information to researchers and medical decision-makers;
    • if PI is sole monitor of the clinical investigation explain how conflict of interest will be averted 
  2. Assuring compliance with the requirements regarding the reporting of unanticipated problems or adverse experiences:
    • procedures for ensuring appropriate reporting of findings to the IRB;
    • procedures for review or analysis of cumulative safety data to determine whether harm is occurring;
    • whether utilizing a Data and Safety Monitoring Board;
    • whether you will report findings to other entities and if so, what will be reported and how.
  3. Assuring that any action resulting in a temporary or permanent suspension of the study is reported to the appropriate entities (i.e., funding agency): 
    • what will be reported and how;
    • what the criteria will be for suspension or “termination” of the study.
  4. Assuring data accuracy and protocol compliance:
    • quality control measures and who is responsible for implementing;
    • what procedures are in place to ensure protocol adherence.
  5. Assuring communication among multi-center sites adequately protects the participant (if this is a multi-center study in which the lead PI or UK is the coordinating institution):
    • consider issues like communication of protocol modifications, data safety monitoring reports, and unanticipated problems
Guidance for Investigator-Initiated Protocols Which Require a DSMP and Data and Safety Monitoring (DSM), or a Data and Safety Monitoring Board (DSMB)

When an investigator-initiated protocol requires a DSMP and DSM, or a DSMB, the IRB reviews the information provided regarding membership and charter, if applicable, and DSMB and/or DSM responsibilities including but not limited to:

  1. Membership:
    • multidisciplinary representation, from relevant specialties.This may include experts such as bioethicists, biostatisticians and basic scientists;
  2. The DSMB should have membership limited to individuals free of apparent significant conflicts of interest, whether they are financial, intellectual, professional, or regulatory in nature:
    • the appropriate size depends on the type of study;
  3. DSM/DSMB charter:
    • a detailed presentation of the membership composition, including qualifications and experience;
    • roles and responsibilities of the DSM or DSMB and if relevant;
    • the authority of the DSM/DSMB (e.g. advisory to the Sponsor, PI);
    • the timing and purpose of DSMB meetings;
    • the procedures for maintaining confidentiality;
    • the format, content and frequency of DSM or DSMB reports;
    • decision rules or specific data to be monitored and statistical procedures including monitoring guidelines, which will be used for analysis and interpretation of data including the identified primary, secondary, and safety outcome variables;
    • actions to be taken upon specific events, outcomes, or end points; and
    • plans for changing frequency of interim analysis as well as procedures for recommending protocol changes.
  4. DSM/DSMB responsibilities:
    • initial review of the proposed research to assure quality study conduct;
    • procedures to review and assure quality of study conduct including data management and quality control procedures;
    • evaluation of the quality of ongoing study conduct by reviewing the study accrual, compliance with eligibility, participant adherence to study requirements, and accuracy and completeness of data;
    • considering factors external to the study when relevant information becomes available, such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the study;
    • recommendations of early termination based on efficacy results;
    • recommendations of termination due to unfavorable benefit-to-risk or inability to answer study questions;
    • recommendations of continuation of ongoing studies;
    • considering overall picture; primary and secondary analysis;
    • modifying sample sizes based on ongoing assessment of event rates; and review of final results.
Considerations for When to Create an Independent Data and Safety Monitoring Board or Committee:

NIH Guidance:

The NIH requires data and safety monitoring, generally, in the form of Data and Safety Monitoring Boards (DSMBs) for phase III clinical trials. For earlier trials (phase I and II), a DSMB may be appropriate if the studies have multiple clinical sites, are blinded (masked), or employ particularly high-risk interventions or vulnerable populations.

FDA Guidance:

DSMB's or Data Monitoring Committees (DMC) have generally been established for large, randomized multisite studies that evaluate treatments intended to prolong life or reduce risk of a major adverse health outcome such as a cardiovascular event or recurrence of cancer. DMCs are generally recommended for any controlled trial of any size that will compare rates of mortality or major morbidity, but a DMC is not required or recommended for most clinical studies. DMCs are generally not needed, for example, for trials at early stages of product development. They are also generally not needed for trials addressing lesser outcomes, such as relief of symptoms, unless the trial population is at elevated risk of more severe outcomes. The FDA Guidance provides details on additional factors to consider when determining whether to establish a DMC for a particular trial which relate primarily to safety, practicality, and scientific validity.
Additional Resources