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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.
- 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.
- If the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research applies to your study, send summary reports to the sIRB.
- Find more information on human subjects requirements at
Applicants or grantees with questions should read Contacting Program Officers and Grants Management Specialists.
DAIT: James McNamara
DIR: Sara Healy
DMID: Joni Love
DCR: Kelly Cahill
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