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Clinical Trial Monitoring SOP

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


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 see Human Subjects SOPs and Data and Safety Monitoring Boards SOP.


As part of NIAID's 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's clinical trial monitoring requirements, see the NIAID Clinical Terms of Award and follow all application instructions.

A 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 on human subjects requirements at NIAID Human Subjects Resources on the Research Funding website.


Tamara Lewis-Johnson

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45 CFR 46, Protection of Human Subjects

Clinical Trial Safety Monitoring and Reporting Requirements flowchart

Grant Application, Electronic SOP

Grant Application, Paper SOP

Human Subjects Research Requirements SOP and other Human Subjects SOPs

NIAID's Application portal

NIH Guide, Guidance on Reporting Adverse Events to IRBs for Multicenter Clinical Trials, June 11, 1999

NIH Office of Biotechnology Activities

Office for Human Research Protections, HHS

Planned Enrollment Report

Trans NIAID Clinical Research Toolkit

Last Updated October 01, 2014

Last Reviewed January 12, 2016