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., 12/19/2018
E.g., 12/19/2018
Title Status FDA Centersort descending Date Posted
Sequential Surveillance for Drug Safety in a Regulatory Environment Complete 03/05/2018
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
Statistical Methods for Improving Confounder Adjustment For Emergent Treatment Comparison Complete 04/22/2014
HOI Literature Review- Transfusion/Graft Infections Complete 05/27/2011
Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib) In progress 05/11/2018
Data Quality and Characterization Procedures and Findings Report - Year 1 Complete 03/27/2012
Enhancing TreeScan for Long-Term Follow-up (TreeScan Censoring) Complete 06/15/2017
Intussusception Algorithm Defined in "Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)" Complete 05/07/2018
15 Cohorts of Interest for Surveillance Preparedness Complete 05/07/2014
HOI Literature Review - Lymphomas Complete 05/27/2011
FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries In progress 10/16/2018
Distributed Database Summary Report - Year 1 Complete 03/27/2012
TreeScan for Drugs In progress 06/26/2017
Intracranial Hemorrhage Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Intracranial Hemorrhage" Complete 05/07/2018
Two-Dimensional Scan Statistics for Assessing Vaccine Safety in Pregnancy (PRISM) Complete 04/27/2016
HOI Literature Review - ABO Incompatibility Complete 05/27/2011
FDA-Catalyst COPD, Asthma, And Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies In progress 11/06/2018
Data Quality Review and Characterization Programs v4.1.0 Complete 02/28/2018
Common Data Model Expansion Plan Complete 01/29/2013
TreeScan with Propensity Scores Complete 06/26/2017
Gastrointestinal Bleed Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Gastrointestinal Bleed" Complete 05/10/2018
Quantifying the Impact of Time-Varying Baseline Risk Adjustment in the Self-Controlled Risk Interval Design (PRISM) Complete 11/04/2015
HOI Literature Review - CVA/TIA Complete 06/02/2011
Modular Program 1: Characterization of Use of Medical Product Exposures Retired 11/27/2012
Common Data Model and Data Core Activities Report - Year 2 Complete 03/07/2013
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete 08/15/2018
Coding Trend Analyses: Myositis Complete 06/15/2018
Decision Analysis for Surveillance and Health - Pandemic Influenza (PRISM) Complete 11/13/2014
HOI Literature Review - Seizures Complete 06/06/2011
Modular Program 2: Characterization of Use of Medical Product Exposures among Individuals with or without Condition(s) of Interest Retired 03/10/2013
Distributed Database Summary Report - Year 2 Complete 03/12/2013
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case In progress 09/15/2017
Coding Trend Analyses: Myocarditis Complete 06/15/2018
TreeScan Power (PRISM) In progress 11/13/2014
HOI Literature Review - Anaphylaxis Complete 06/10/2011
Modular Program 3: Frequency of Select Events During Exposure to a Drug/Procedure Group of Interest Retired 07/14/2014
Common Data Model and Data Core Activities Report - Year 3 Complete 10/08/2013
Evaluation of New Technologies Associated with Chart Review Complete 08/16/2017
Coding Trend Analyses: Rhabdomyolysis Complete 06/15/2018
TreeScan Extension (PRISM) In progress 11/13/2014
HOI Literature Review - Respiratory Failure Complete 06/13/2011
Modular Program 4: Frequency of Select Events During Concomitant Exposure to a Drug/Procedure Groups of Interest Complete 06/11/2014
Distributed Database Summary Report - Year 3 Complete 01/30/2014
Death Data Exploration Complete 08/17/2017
Gastrointestinal Bleeding Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins" Complete 06/25/2018
HOI Literature Review - Transfusion Sepsis Complete 06/15/2011
Modular Program 5: Background Rates for Health Outcomes of Interest Retired 03/10/2013
Mini-Sentinel Coordinating Center Data Group: Year Four Report of Activities Complete 04/08/2014
Methotrexate Medication Errors In progress 08/17/2017
Coding Trend Analyses: Acute Myocardial Infarction Complete 09/18/2018
HOI Literature Review - Erythema Multiforme Complete 06/16/2011
Modular Program 6: Frequency and Duration of Treatment Following an Event of Interest Retired 06/11/2014
Distributed Database Summary Report - Year 4 Complete 05/09/2014
Evaluating Variability with 1:1 Propensity Score-Matched Analyses In progress 08/18/2017
Coding Trend Analyses: Angioedema Complete 09/18/2018
HOI Literature Review - Atrial Fibrillation Complete 06/30/2011
Modular Program 7: Drug Use, Medical Diagnoses, and Medical Procedures Before and After an Exposure or Event of Interest Retired 06/11/2014
Common Components SAS® Code v1.2 Complete 01/13/2015
The Use of Propensity Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring In progress 08/18/2017
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Angioedema Events After Use of Angioensin-Converting Enzyme (ACE) Inhibitors versus Beta-blockers In progress 01/31/2016
Coding Trend Analyses: Ischemic Stroke Complete 09/18/2018
Validation of Acute Myocardial Infarction Cases Complete 07/01/2011
Modular Program 9: Background Rates and Characterization of Health Outcomes of Interest among Individuals with or without Condition(s) of Interest Retired 06/11/2014
Modular Program 8: Uptake, Use, and Persistence of New Molecular Entities (NMEs) Retired 06/27/2014
Mini-Sentinel Coordinating Center Data Group: Year Five Report of Activities Complete 11/24/2015
Inverse Probability of Treatment Weighting Functional Specifications and Prototype Development In progress 08/24/2017
Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete 09/30/2016
HOI Literature Review - Pulmonary Fibrosis Complete 07/14/2011
Sentinel Distributed Query Tool Complete 06/29/2016
Distributed Database Summary Report - Year 5 Complete 11/24/2015
Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database (MSDD) Complete 11/20/2017
Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program Complete 04/27/2018
HOI Literature Review - Orthopedic Implant Removal Complete 07/19/2011
Distributed Query Tool Summary Table Descriptions Complete 06/24/2016
Sentinel Data Quality Assurance Practices Complete 03/23/2017