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Standard Operating Procedure Table of Contents
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Purpose
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.
Procedure
Clinical grant applications must follow instructions in either theGrant
Application Guide (for an electronic application) or PHS
398 (for a paper application).
All awards must comply with
the NIAID Clinical Terms
of Award. NIAID can award applications and proposals only
if they comply with all policies.
Principal Investigators
- 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. See
the June
10, 1998, Guide notice.
- For additional information, read the June
5, 2000, Guide notice.
- Data and safety monitoring functions and oversight are distinct from
the requirement for institutional
review board (IRB) protocol review and approval.
- For trials with DSMBs, send summary reports of adverse events to
each IRB involved in the study; see the June
11, 1999, Guide notice for details.
- Find more information on human subjects requirements at NIAID
human subjects resources on the Research
Funding Web site, and in our Clinical
Trial Monitoring SOP and Human Subjects
Certifications: IRB or IEC SOP.
NIAID Staff
Read Clinical Research Toolkit: Guidance, Policies, and Standard Operating Procedures.
Contacts
Applicants or grantees with questions should Contact Staff for Help.
Contact for NIAID Staff
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, HHS
Electronic Application Resources
Grant Application, Electronic SOP
Grant Application, Paper SOP
Human Subjects questions and answers
Human Subjects SOPs
Office for Human Research Protections,
HHS
Trans
NIAID Clinical Research Toolkit
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