Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jun;69(5):1050-1055.
doi: 10.1136/jim-2021-001779.

Institutionally chartered Data and Safety Monitoring Boards: structured approaches to assuring participant safety in clinical research

Blair Holbein  1 , Marie T Rape  2 , Barbara N Hammack  3 , Ann Melvin  4   5 , Carson Reider  6 , Tamsin A Knox  7   8
Affiliations

Institutionally chartered Data and Safety Monitoring Boards: structured approaches to assuring participant safety in clinical research

Blair Holbein et al. J Investig Med. 2021 Jun.

Abstract

Data and Safety Monitoring Boards (DSMBs) derived from the need to monitor large federally funded multi-center clinical trials and evolved to include commercial and other large and complex trials. Eventually, academic health centers also created institutionally focused trial monitoring mechanisms. The basic general principles that define traditional DSMBs extend to the institutional level. The primary responsibilities are assuring safety of the participants, preserving the integrity of the trial, and ensuring the reliability of the results. Institutionally chartered DSMBs meet these responsibilities but usually have fewer members, have a structure specific to the needs of the trial, are more focused and/or have different scope reviewing smaller, single site, higher risk, and investigator-initiated studies and are flexible to accommodate institution-specific requirements and approaches. Their purpose is to meet the responsibilities of oversight for safety and data integrity, ensure proper study design, rigor and conduct, as well as provide statistical support appropriate to the setting of the research. Academic health centers should recognize the importance and existence of institution level safety and data monitoring and provide support as much as possible. Investigators should have sufficient resources available to assemble DSMBs. The Clinical and Translational Science Awards Collaborative DSMB Workgroup provides an online manual to assist investigators.

Keywords: public policy; research.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

References

    1. National Institutes of Health. Data and Safety Monitoring [web site]|. 2020. Available at: https://grants.nih.gov/policy/humansubjects/policies-and-regulations/dat.... Accessed 03/31/2020.
    1. National Cancer Institute Clinical and Translational Research Operations Committee. Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials. 2014.
    1. US Food and Drug Administration. Guidance for Clinical Trial Sponsors, Establishment and Operation of Clinical Trial Data Monitoring Committees: US Department of Health and Human Services, 2006.
    1. Heart Special Project Committee to the National Advisory Heart Council. Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. Controlled Clinical Trials 1988;9(2):137–48. doi: 10.1016/0197-2456(88)90034-7 [published Online First: 1988/06/January]. - DOI - PubMed
    1. Wittes J Data Safety Monitoring Boards: A Brief Introduction. Biopharm Rep 2000;8(1):1–7.

Publication types