Report Finder

All Sentinel reports, surveillance tools, FDA assessments, and communication materials may be searched using the options below. Search results can be further sorted by title, project status, and date posted by clicking on the relevant column header. If you wish to search for FDA Center assessments more specifically by medical product and health outcome, please go to the CDER Assessments and CBER Assessments pages.

E.g., 4/22/2019
E.g., 4/22/2019
Title Status FDA Centersort descending Date Posted
Coding Trend Analyses: Gout Complete 03/28/2019
HOI Evidence Reviews (PRISM) Complete 12/25/2013
Sequential TreeScan Signal Identification Methods Development In progress 12/11/2018
Mini-Sentinel: Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete 03/07/2012
Evaluation of Propensity Score Based Methods in Sentinel Study Settings Using Simulation Experiments Complete 06/15/2017
Coding Trend Analyses: Colon Cancer Complete 03/28/2019
16 Health Outcomes of Interest for Surveillance Preparedness Complete 07/01/2014
Mini-Sentinel: Vaccine Safety Monitoring - Data Characterization Complete 12/27/2013
Mini-Sentinel: Methods to Evaluate Impact of FDA Regulatory Actions Complete 01/24/2013
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative Complete 06/21/2018
Coding Trend Analyses: Cervical Cancer Complete 03/28/2019
Health Outcome Algorithm Inventory Complete 05/23/2016
Characteristics of Patients Using Anti-Diabetic Agents in the People-Centered Research Foundation (PCRF): An Exploratory Query of a Network of Electronic Health Records In progress 03/26/2019
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 2 Complete 04/09/2012
Sequential Surveillance for Drug Safety in a Regulatory Environment Complete 03/05/2018
Coding Trend Analyses: Anal Cancer Complete 03/28/2019
Validation of Lymphoma in ICD-10-CM In progress 02/22/2018
Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control In progress 03/21/2019
Mini-Sentinel: Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete 12/04/2012
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete 06/15/2017
Coding Trend Analyses: Male Breast Cancer Complete 03/28/2019
Validation of Serious Infections among an Immunocompromised Population In progress 11/19/2017
Collection of Patient-Provided Information through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research Complete 01/03/2017
Mini-Sentinel: Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete 01/11/2013
TreeScan for Drugs In progress 06/26/2017
Coding Trend Analyses: Female Breast Cancer Complete 03/28/2019
Venous Thromboembolism Algorithm Defined in "Venous Thromboembolism following Continuous or Extended Cycle Contraceptive Use: a Propensity Score Matched Analysis" Complete 04/23/2018
Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib) In progress 04/11/2019
Mini-Sentinel: Framework for Assessment of Signal Refinement Positive Results Complete 01/27/2013
TreeScan with Propensity Scores Complete 06/26/2017
Coding Trend Analyses: Rectal Cancer Complete 03/29/2019
Seizure Algorithm Defined in "Seizure following Ranolazine Use: a Self-Controlled Risk Interval Analysis" Complete 04/24/2018
FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries In progress 10/16/2018
Mini-Sentinel: Developing, Implementing, and Testing a Program for High-Dimensional Propensity Score Adjustment in the Mini-Sentinel Distributed Data Environment Complete 10/11/2013
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete 08/15/2018
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case Complete 03/06/2018
Coding Trend Analyses: Thyroid Cancer Complete 03/29/2019
Stroke Algorithm Defined in "Stroke following Typical or Atypical Antipsychotic Use in non-Elderly Patients: a Propensity Score Matched Analysis" Complete 04/23/2018
HOI Literature Review - Congestive Heart Failure Complete 02/08/2011
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 3 Complete 11/20/2013
Evaluation of New Technologies Associated with Chart Review Complete 08/16/2017
Coding Trend Analyses: Febrile Seizures Complete 04/03/2019
Mini-Sentinel: Anonymous Linking of Distributed Databases Complete 09/24/2013
Stroke Algorithm Defined in "Stroke following Atypical Antipsychotic or Z-Hypnotic Use in Patients with Prior Use of Selective Serotonin Reuptake Inhibitors (SSRIs): a Propensity Score Matched Analysis" Complete 04/23/2018
HOI Literature Review - Depression Complete 02/08/2011
Mini-Sentinel: Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities Complete 01/14/2014
Death Data Exploration Complete 08/17/2017
Coding Trend Analyses: Bell's Palsy Complete 04/03/2019
Mini-Sentinel: Identifying Complementary Data Sources (PRISM) Complete 02/13/2012
Validation of Stillbirth in ICD-10-CM In progress 07/17/2018
HOI Literature Review - Suicide Complete 02/07/2011
Demonstrate Feasibility of New Mini-Sentinel Group Sequential Monitoring Methods in a Distributed Setting by Implementing Them in Practice Complete 01/29/2014
Methotrexate Medication Errors Complete 12/31/2017
Coding Trend Analyses: Anaphylaxis Complete 04/03/2019
Mini-Sentinel: Equipping PRISM for Pandemic Influenza: Interoperability Specification for Data Partners and Immunization Registries Complete 10/16/2013
Hypoglycemia Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide" Complete 04/26/2018
HOI Literature Review - Cardiac Arrhythmias Complete 03/02/2011
Mini-Sentinel: Continuous versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Complete 03/13/2014
Developing Approaches to Conducting Randomized Trials using the Mini-Sentinel Distributed Database Complete 04/23/2014
Evaluating Variability with 1:1 Propensity Score-Matched Analyses In progress 08/18/2017
Coding Trend Analyses: Prostate Cancer Complete 04/03/2019
Mini-Sentinel: Birth Certificate Data Matching for the Postlicensure Rapid Immunization Safety Monitoring (PRISM) Program Complete 04/24/2016
Complex Regional Pain Syndrome (CRPS), Uveitis, Acute Disseminated Encephalomyelitis (ADEM), and Acute Pericarditis Algorithms Defined in "Sequential Analysis of Gardasil 9 Safety" Complete 04/30/2018
HOI Literature Review - Pancreatitis Complete 05/20/2011
Mini-Sentinel: Statistical Methods for Improving Confounder Adjustment For Emergent Treatment Comparison Complete 04/22/2014
The Use of Propensity Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring In progress 08/18/2017
Coding Trend Analyses: Guillain-Barré Syndrome Complete 04/03/2019
Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance Complete 11/30/2016
Clostridium difficile Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins" Complete 04/30/2018
HOI Literature Review- Transfusion/Graft Infections Complete 05/27/2011
Mini-Sentinel: 15 Cohorts of Interest for Surveillance Preparedness Complete 05/07/2014
Inverse Probability of Treatment Weighting Functional Specifications and Prototype Development In progress 08/24/2017
Coding Trend Analyses: Ischemic Heart Disease Complete 04/05/2019
Exploration of Potential for Sentinel and PCORnet Data Linkage Complete 11/24/2015
Intussusception Algorithm Defined in "Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)" Complete 05/07/2018