Notice

Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

Updates regarding government operating status and resumption of normal operations can be found at USA.gov.

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.

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

NIAID Staff

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

Contacts

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

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

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 Human Subjects SOPs

Office for Human Research Protections, HHS

Trans NIAID Clinical Research Toolkit

Content last reviewed on March 16, 2015