Data and Safety Monitoring Boards (DSMB) SOP

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 the Human Subjects section on Rules & Policies—Special Considerations.

Procedure

Clinical grant applications must comply with application instructions and NIAID Clinical Terms of Award. NIAID can award grants and contracts only if they comply with all policies.

For more information on DSMB requirements, refer to the NIH Policy and Guidance section on NIH’s Data and Safety Monitoring webpage.

Principal Investigators

  • If you are conducting a multisite clinical trial involving interventions that pose a potential risk to the participants, you must have a DSMB to monitor the trial.
  • Data and safety monitoring functions and oversight are distinct from the requirement for institutional review board (IRB) protocol review and approval.
  • If the NIH Single IRB for Multi-Site or Cooperative Research policy applies to your study, send summary reports to the sIRB.

NIAID Staff

Read Trans NIAID Clinical Research Toolkit—Resources.

Contacts

Applicants or grantees with questions should read Contacting Program Officers and Grants Management Specialists.

DAIDS: Delta Saint-Vil

DAIT: James McNamara

DIR: Faith Bashore

DMID: OCRASafety@mail.nih.gov

DCR: Negin Atri

DEA: Contact for NIAID Staff

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

Apply for a Grant

Grant Application SOP

Research Using Human Subjects

Human Subjects Research Requirements SOP and other Rules & Policies—Special Considerations

Office for Human Research Protections, HHS

Rules and Policies for Clinical Research

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