See the Glossary for more terms.
Some links will work for NIAID staff only.
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.
Read Clinical Research Toolkit: Guidance, Policies, and Standard Operating Procedures.
Applicants or grantees with questions should read Communicating With NIAID—How to Get Help.
Contact for NIAID Staff
DAIDS: Lawrence Fox, Ron Barnett
DAIT: James McNamara
DIR: Sara Healy
DMID: Joni Love
DCR: Kelly Cahill
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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