Clinical Trial Monitoring

Purpose

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 Board SOP.

Procedure

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 each IC 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.

Grant applications must follow instructions in either the Grant Application Guide (for an electronic application) or PHS 398 (for a paper application).

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 Human Subjects, Clinical Research resources on the Research Funding Web site.

Contacts

Anna Ramsey-Ewing, ar15o@nih.gov, 301/435-8536

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

Clinical Trial Safety Monitoring and Reporting Requirements flowchart

Electronic Application Resources

Grant Application, Electronic SOP

Grant Application, Paper SOP

Human Subjects SOPs

NIH Guide, Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials, June 5, 2000

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

Targeted/Planned Enrollment Table

Trans NIAID Clinical Research Toolkit