Data and Safety Monitoring Boards (DSMB)
Some links will work for NIAID staff only.
Standard Operating Procedure Table of Contents
Purpose
To oversee and monitor clinical trials to ensure participant safety and the validity and integrity of the data. This SOP is one of several describing clinical trial requirements; also see Human Subjects SOPs.
Procedure
Clinical grant applications must comply with instructions and with the NIAID Clinical Terms of Award. NIAID can award applications and proposals only if they comply with all policies.
Principal Investigators
- If you are conducting a multisite clinical trial involving interventions that pose more than a minimal risk to the participants, you must have a data and safety monitoring board (DSMB) to monitor the trial.
- For additional information, read the June 10, 1998, and June 5, 2000, Guide notices.
- Data and safety monitoring functions and oversight are distinct from the requirement for institutional review board (IRB) protocol review and approval.
- For trials with DSMBs, send summary reports of adverse events to each IRB involved in the study; see the June 11, 1999, Guide notice for details.
- Find more information on human subjects requirements at
NIAID Staff
Read Clinical Research Toolkit: Guidance, Policies, and Standard Operating Procedures.
Contacts
Applicants or grantees with questions should Contact Staff for Help.
Contact for NIAID Staff
If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.
Links
45 CFR 46, Protection of Human Subjects, HHS
NIAID's Application portal
Grant Application, Electronic SOP
Grant Application, Paper SOP
Human Subjects questions and answers
Human Subjects Research Requirements SOP and other Human Subjects SOPs
Office for Human Research Protections, HHS
Trans NIAID Clinical Research Toolkit