Individual Case Safety Reports —How to Determine the Onset Date of an Adverse Reaction A Survey

• Published in: Drug safety Vol. 34; no. 4; pp. 299 - 305
• Main Authors: Klepper, Michael J., Edwards, Brian
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.04.2011; Adis International; Wolters Kluwer Health, Inc
• Subjects: Adverse and side effects; Adverse Drug Reaction Reporting Systems - organization & administration; Adverse Drug Reaction Reporting Systems - standards; Biological and medical sciences; Clinical trial. Drug monitoring; Databases, Factual; Drug Safety and Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drugs; General pharmacology; Humans; Medical Records Systems, Computerized - organization & administration; Medical Records Systems, Computerized - standards; Medical sciences; Medicine; Medicine & Public Health; Pharmacology. Drug treatments; Pharmacology/Toxicology; Pilot Projects; Regulatory compliance; Short Communication; Surveys; Surveys and Questionnaires; United States; Onset Date; Design Space; Adverse Reaction; Answer Number; Causality Assessment; Case study; Human; Drug; Survey; Age of onset; Toxicity; Pharmacovigilance; Date; Notification

Background: The building blocks of a pharmacovigilance system depend primarily on good quality individual case safety reports (ICSRs), which are stand-alone summaries describing one or more suspected adverse reactions that occur while a subject is taking either an investigational or marketed medicin...