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Standard Operating Procedure Table of Contents
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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
NIAID's Application portal
Grant Application, Electronic SOP
Grant Application, Paper SOP
Human Subjects Research Requirements SOP and other 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 |