Data Safety Monitoring Boards

  • Rachael A. CallcutEmail author
Part of the Success in Academic Surgery book series (SIAS)


The overall purpose of the Data Safety Monitoring Board, or Data Monitoring Committee, is to insure the integrity and safety of clinical trial research. Federal guidelines have been established by the Food and Drug Administration and the National Institutes of Health regarding when a board or committee is required for federally funded research. These boards or committees serve to advise the sponsor and/or researchers of the study on the safety of the trial, the continuing validity of the trial, and the scientific merit of the trial. A data safety monitoring board charter is typically created prior to initiation of a clinical trial to explicitly address the mission and operating procedures for the committee. Committees can terminate trials early for either futility or reaching an early conclusion from interim analysis showing clear benefit. Even if a Data Safety Monitoring Board is not required, most clinical research trials should have a data safety monitoring plan.


  1. 1.
    Calis KA, Archdeacon P, Bain RP, Forrest A, Perlmutter J, DeMets DL. Understanding the functions and operations of data monitoring committees: Survey and focus group findings. Clin Trials. 2017;14(1):59–66.CrossRefGoogle Scholar
  2. 2.
    Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, Meisel A, Bain RP, Konstam MA, Pencina MJ, Gordon DJ, Mahaffey KW, Hennekens CH, Neaton JD, Pearson GD, Andersson TLG, Pfeffer MA, Ellenberg SS. Data Monitoring Committee: promoting best practices to address emerging challenges. Clin Trials. 2017;14(2):115–23.CrossRefGoogle Scholar
  3. 3.
    Levinson DR. Data safety and monitoring boards in NIH clinical trials: meeting guidance, but facing some issues. Washington, DC: Department of Health and Human Services, Office of the Inspector General; 2013. (OEI-12-11-00070).Google Scholar
  4. 4.
    FDA. Guidance for clinical trial sponsors: establishment and operations of clinical trial monitoring committees. 2006. Accessed 28 Mar 2019.
  5. 5.
    Marston L, McKenzie DR, Freemantle N. Pursuit of truly independent data monitoring committees in research. BMJ. 2016;353:i2309.CrossRefGoogle Scholar
  6. 6.
    DeMets DL, Ellenberg SS. Data monitoring committees – expect the unexpected. NEJM. 2016;375(14):1365–71.CrossRefGoogle Scholar
  7. 7.
    Gewandter JS, Kitt RA, Hunsinger MR, Poku J, Lozano J, Chaudari J, Evans S, Gross RA, McDermott MP, Rowbothan MC, Turk DC, Dworkin RH. Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: an ACTTIION systematic review. J Clin Epidemiol. 2017;83:101–7.CrossRefGoogle Scholar
  8. 8.
    Bierer B, Winkler S, Bernstein H, Myerson J, Kim M. Data safety monitoring guidance. Harvard Catalyst, Regulatory Foundations, Ethics, and Law Program. Boston, MA: The Harvard Clinical Translational Science Center; 2018.Google Scholar
  9. 9.
    DAMOCLES Study Group. A proposed charter for clinical trial data monitoring committees: helping them do their job well. Lancet. 2005;365(9460):711–22.CrossRefGoogle Scholar
  10. 10.
    Tyson JE, Pedroza C, Wallace D, D’Angio C, Bell EF, Das A. Stopping guidelines for an effectiveness trial: what should the protocol specify? Trials. 2016;17(240):1–4.Google Scholar
  11. 11.
    Ellenberg SS, Culbertson R, Gillen DL, Goodman S, Schrandt S, Zirkle M. Clin Trials. 2015;12(5):530–6.CrossRefGoogle Scholar
  12. 12.
    Swedberg K, Borer JS, Pitt B, Pocock S, Rouleau J. Challenges to data monitoring committees when regulatory authorities intervene. NEJM. 2016;374(16):1580–4.CrossRefGoogle Scholar
  13. 13.
    Harrington D, Drazen JM. Learning form a trial stopped by a Data and Safety Monitoring Board. NEJM. 2018;378(21):2031–2.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Department of SurgeryUniversity of California San FranciscoSan FranciscoUSA

Personalised recommendations