Outsourcing administration of your safety oversight group

You may think your team has covered all the bases when it comes to protecting the safety of human subjects in your clinical trial. You have a team of monitors in place to review reports and ensure your trial follows safety protocols. However, every trial needs a system of checks and balances.

Your monitors are probably great at spotting inconsistencies in individual reports, but who is checking their work and evaluating cumulative safety data to determine whether it’s safe to continue the trial?  

When an adverse event occurs, who is investigating it and determining an appropriate course of action?

Enlisting an objective third party for safety monitoring gives your subjects and your study another layer of protection, adding credibility and consistency. There are several different types of safety monitoring groups, including:

• Data safety monitoring committees or data safety monitoring boards
• Clinical events committees
• Medical monitoring groups

While each has a different focus, they all share a common goal: ensuring the safety of your patients and the integrity of your data. Your study may need one or all of these, depending on its scope and potential risks.

IMARC has developed a list of best practices for enlisting safety monitoring groups for the best results.

Download our checklist today to learn more about when and how to outsource safety monitoring.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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