FDA’s Sentinel System is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from monitoring the use of drugs, describing the course of illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity and also visit:
FDA Sentinel System's Coronavirus (COVID-19) Activities
Sentinel Projects
10/14/2020
The COVID-19 Natural History Master Protocol effort involves the development of a protocol designed to identify multiple COVID-19 cohorts to support a variety of on-...
09/14/2020
This project supports FDA’s COVID-19 response through:
- Adding COVID-19 laboratory results data to the Sentinel Common Data Model (SCDM) for routine querying in the Active...
07/23/2020
This activity encompasses two aims that are using inpatient electronic health record data from HCA Healthcare:
Aim 1: The objective for Aim 1 is to describe the...
06/17/2020
The goal of this project is to describe the natural history of coagulopathy among COVID-19 patients in the inpatient setting. Activities will include development of a study synopsis for...
06/05/2020
The purpose of this project is to design and implement a system that enables rapid querying of electronic health record (EHR) data to support FDA's COVID-19 response. The project will...
06/01/2020
This activity supports investigators of COVID-19 related drug trials that need a digital platform for patient informed consent when face to face contact is not possible or practical. The...
06/01/2020
The goal of this project is to conduct algorithm validation using diagnosis codes to identify potential hospitalized COVID-19 cases and validate the algorithm(s) using laboratory test...
05/15/2020
This ongoing methods development project by the FDA Office of Counterterrorism and Emerging Threats (OCET) to examine outcomes among hospitalized patients with influenza-like illness and...
04/20/2020
This study aims to sequentially monitor priority drugs for the care of patients hospitalized with COVID-19, including sedatives and drugs used to assist with mechanical ventilation,...
04/07/2020
The purpose of this project is to identify promising sources of electronic health records to strengthen the Sentinel System in areas of pediatric, cancer, pregnancy, birth outcomes, and...
