Clinical Trial Monitoring SOP

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

Some links will work for NIAID staff only.


Clinical trial monitoring requires data collection and analysis throughout a project to ensure appropriateness of the research and project design, validity and integrity of the data, and protection of human subjects.

This SOP is one of several describing clinical trial requirements; also refer to the see Human Subjects topic on Rules and Policies: Special Considerations and Data and Safety Monitoring Boards (DSMB) SOP.


As part of the NIAID system for overseeing and monitoring clinical trials, NIAID and the awardee jointly decide the monitoring type before a clinical trial begins.

All clinical trials require monitoring, and the method chosen must be commensurate with the degree of risk. When risk is more than minimal, NIAID strongly recommends independent safety monitoring for clinical trials of investigational drugs, investigational devices, or biologics; phase III and IV clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers.

Independent monitoring can take a variety of forms; phase III and IV clinical trials generally require an independent data and safety monitoring board (DSMB).

Applicants, grantees, and staff all have responsibilities for monitoring clinical research. NIH policy for Data and Safety Monitoring requires institutes to oversee and monitor clinical trials; some monitoring requirements vary by NIAID division.

Domestically conducted clinical research supported by NIAID must comply with U.S. state and local regulations. If the research is conducted outside the U.S., it must also comply with host country regulations. Whenever regulations differ between authorities, the more restrictive regulation applies.

For guidance on NIAID clinical trial monitoring requirements, see NIAID Clinical Terms of Award and follow all application instructions.

A principal investigator (PI) can conduct human subjects research only if complying with all requirements. If peer reviewers determine a PI is not in compliance, NIAID may withhold funds and restrict that investigator from conducting human subjects research until all issues are resolved.

Find more information and advice on the following NIAID pages:


If you have questions about clinical trial monitoring, contact

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at


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