title: Systematic identification and classification of adverse events in human research.
abstract: Widely accepted standards and safeguards for research participants now include systematic surveillance and recording of adverse events. In the absence of a uniform regulation or structure for such reporting, each institution must now establish suitable yet efficient procedures to accomplish this task. We report herein our single center experience with a customized data collection, storage and review system specifically designed to identify and react appropriately to adverse events. Adverse events are classified by each investigator using three criteria in specific order: seriousness, expectedness and relatedness to the investigational intervention. Once classified, events are entered into an online database that includes collation, retrieval and search capabilities. Events meeting specified criteria are reviewed and adjudicated on a weekly basis by The University of Connecticut Research Adverse Events Committee, which makes advisory recommendations to the hospital's two Institutional Research Boards ranging from modification of informed consent to study suspension. Three hundred and seventy-one serious adverse events from > 900 studies were reviewed in the previous academic year. Our system, which combines timely on-line reporting with regular surveillance, provides a potential model that meets the need for comprehensive yet practical adverse events assessment and reporting.
authors.affiliation: University of Connecticut Health Center, Department of Cardiology, 263 Farmington Ave, Farmington, CT 06117, USA. silverman@nso1.uchc.edu
authors.forename: David I
authors.initials: DI
authors.lastname: Silverman
authors.forename: Lisanne
authors.initials: L
authors.lastname: Cirullo
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: DeMartinis
authors.forename: Kathryn
authors.initials: K
authors.lastname: Damato
authors.forename: Margaret
authors.initials: M
authors.lastname: DeMeo
authors.forename: Gustavo A
authors.initials: GA
authors.lastname: Fernandez
authors.forename: Laura
authors.initials: L
authors.lastname: Glynn
authors.forename: Upendra
authors.initials: U
authors.lastname: Hegde
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Laskay
authors.forename: Robin
authors.initials: R
authors.lastname: Leger
authors.forename: Khamis
authors.initials: K
authors.lastname: Abu-Hasaballah
authors.forename: Joan M
authors.initials: JM
authors.lastname: Caron
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D000465:Algorithms; D035843:Biomedical Research / Q000379:methods*; D003625:Data Collection / Q000592:standards*; D028744:Ethics Committees, Research / Q000592:standards*; D032984:Ethics, Research; D006805:Human Experimentation / Q000592:standards*; D006801:Humans