This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Some links will work for NIAID staff only.
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 comply with instructions and 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.
- For additional information, read the June 10, 1998, and June 5, 2000, Guide notices.
- Data and safety monitoring functions and oversight are distinct from the requirement for institutional review board (IRB) protocol review and approval.
- If the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research applies to your study, send summary reports to the sIRB.
- Find more information on human subjects requirements at
NIAID Staff
Read Clinical Research Toolkit: Guidance, Policies, and Standard Operating Procedures.
Contacts
Applicants or grantees with questions should read Contacting Program Officers and Grants Management Specialists.
DAIDS: Brendan Cole, Delta Saint-Vil
DAIT: James McNamara
DIR: Sara Healy
DMID: Joni Love
DCR: Kelly Cahill
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 deaweb@niaid.nih.gov.
Links
45 CFR 46, Protection of Human Subjects, HHS
Human Subjects Research Requirements SOP and other Research Rules & Policies