We'll Discuss Data and Safety Monitoring With You

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Though your monitoring plans go through peer review, you will work with NIAID to make the final decision about safety monitoring before you begin the study. You should discuss this topic with your program officer early on.

Remember that monitoring requirements may vary depending on the nature, size, and complexity of the clinical trial. For example, data and safety monitoring boards (DSMB) are required for multisite clinical trials involving high-risk interventions, all phase III clinical trials, and occasionally other types of trials.

For more details, see Create a Data and Safety Monitoring Plan.

One of the following will conduct the monitoring:

• Independent Safety Monitor -- a physician or other expert who is independent of the study and available to review and recommend actions regarding adverse events and other safety issues.
• Independent Monitoring Committee or Safety Monitoring Committee -- a small group of independent investigators and biostatisticians who review data.
• DSMB -- an independent committee that reviews interim safety and efficacy data and provides advice on continuing, modifying, or terminating the study.

We may require you to use an established NIAID DSMB if your proposed study poses sufficient risk to subjects. To inquire about this, contact your program officer.

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