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Data and Safety Monitoring Boards (DSMB) SOP

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This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.


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.


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


Read Clinical Research Toolkit: Guidance, Policies, and Standard Operating Procedures.


Applicants or grantees with questions should read Communicating With NIAID—How to Get Help.

Lock icon: This link will not work for public visitors.Contact for NIAID Staff

DAIDS: Lawrence Fox, Ron Barnett

DAIT: James McNamara

DIR: Sara Healy

DMID: Joni Love

DCR: Kelly Cahill

If you have knowledge to share or want more information on this topic, email with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.


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

Last Updated April 13, 2016

Last Reviewed March 16, 2015