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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
Evaluation of Existing Approaches to EHR-based Signal Identification Complete
TreeScan in Pregnancy In progress
Sequential TreeScan Methods Development Complete
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery Complete
ARIA Tool Enhancement: Integrating TreeScan Signal Identification Capabilities Complete
Development and Evaluation of a Global Propensity Score for Data Mining with Tree-Based Scan Statistics Complete
TreeExtraction Documentation In progress
TreeScan Extension (PRISM) Complete
Postlicensure Medical Product Safety Data-Mining: Power Calculations for Bernoulli Data Complete
TreeScan for Drugs Complete
TreeScan with Propensity Scores Complete
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete
TreeScan Power (PRISM) Complete
Outcome-Based TreeScan Analyses (DrugSCAN) Complete
Mini-Sentinel: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete
Evaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance Protocol Complete
Vaccine Safety Monitoring - Adverse Events Complete