Question 1

What is the Sentinel Initiative's main goal?

Accepted Answer

The main goal of the Sentinel Initiative is to improve how the FDA evaluates the safety and performance of medical products.

Question 2

How does Sentinel get its data?

Accepted Answer

Sentinel gets its data from a variety of sources, including electronic health records, claims data, and other real-world data sources.

Question 3

How does Sentinel protect the privacy and security of the data it uses?

Accepted Answer

Sentinel has strict principles and policies in place to protect the privacy and confidentiality of the data it uses. This includes measures to ensure the data is secure and only used for authorized purposes.

Question 4

What types of studies can Sentinel conduct?

Accepted Answer

Sentinel can conduct a variety of studies, including individual drug analyses, assessments of the ability of the Adverse Event Reporting System (ARIA) to evaluate safety concerns, and studies on vaccines, blood products, devices, and radiological health.

Question 5

How can non-Sentinel investigators use the Sentinel system?

Accepted Answer

Non-Sentinel investigators can use the Sentinel system for routine querying and various levels of analyses, as well as access software packages and toolkits developed by Sentinel.

U.S. Food and Drug Administration (FDA)

Company Overview

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About U.S. Food and Drug Administration (FDA)

Frequently Asked Questions about U.S. Food and Drug Administration (FDA)

What is the Sentinel Initiative's main goal?

How does Sentinel get its data?

How does Sentinel protect the privacy and security of the data it uses?

What types of studies can Sentinel conduct?

How can non-Sentinel investigators use the Sentinel system?

Technologies Used