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Signal Identification in the Sentinel System

What Is Signal Identification?

Signal identification is the detection of new and unsuspected potential safety concerns. The information below describes how signal identification works.

1. Signal identification detects unexpected, higher numbers of health outcomes

These methods work by screening numerous health outcomes that occur after exposure to a medical product.

2. A clinical review and/or epidemiology safety study follows signal identification

This clinical review or safety study should target the specific health outcome of interest.

The United States Food and Drug Administration Amendments Act of 2007 mandates signal identification in the Sentinel System (Federal Food, Drug, and Cosmetic Act Section 505(k)(3)(C)(i)(3)(cc) (21 U.S.C. 355(k)(3)(C)(i)(III)(cc))). This mandate requires FDA to create a system to identify:

  • Adverse events
  • Potential medical product safety signals

Overview of Signal Identification Techniques Utilized by the Sentinel System

Want to learn more about signal identification? Visit the Resources page for more materials on these methods.

Search Signal Identification Projects

Title Status Date
Development and Evaluation of Electronic Health Record (EHR) Information Extraction Pipeline and Tree-Based Scan Statistic (TBSS) Methods for EHR-Based Signal Detection (DA2) In progress 01/27/2023
Evaluation of Existing Approaches to EHR-based Signal Identification Complete 11/19/2021
TreeScan in Pregnancy In progress 07/14/2021
Sequential TreeScan Methods Development Complete 08/26/2020
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery Complete 02/29/2020
ARIA Tool Enhancement: Integrating TreeScan Signal Identification Capabilities Complete 06/27/2019
Development and Evaluation of a Global Propensity Score for Data Mining with Tree-Based Scan Statistics Complete 05/24/2019
TreeExtraction Documentation In progress 06/29/2018
TreeScan Extension (PRISM) Complete 12/22/2017
Postlicensure Medical Product Safety Data-Mining: Power Calculations for Bernoulli Data Complete 12/22/2017
TreeScan for Drugs Complete 06/26/2017
TreeScan with Propensity Scores Complete 06/26/2017
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete 06/15/2017
TreeScan Power (PRISM) Complete 06/12/2017
Outcome-Based TreeScan Analyses (DrugSCAN) Complete 02/14/2017
Mini-Sentinel: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete 09/30/2016
Evaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance Protocol Complete 06/30/2016
Vaccine Safety Monitoring - Adverse Events Complete 08/28/2013