Data and Safety Monitoring Boards (DSMB) SOP

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

Some links will work for NIAID staff only.


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 Contacting Program Officers and Grants Management Specialists.

Contact for NIAID Staff

DAIDS: Lawrence Fox, Ron Barnett

DAIT: James McNamara

DIR: Sara Healy

DMID: Joni Love

DCR: Kelly Cahill

DEA: Contact for NIAID Staff

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45 CFR 46, Protection of Human Subjects, HHS

Apply for a Grant

Grant Application, Electronic SOP

NIAID Single Institutional Review Board (sIRB) Exceptions SOP

Research Using Human Subjects

Human Subjects Research Requirements SOP and other Research Rules & Policies

Office for Human Research Protections, HHS

Rules and Policies for Clinical Research

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