Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
Interactions
Chapter 20Product Quality Issues
Chapter 21AE Volume, Quality, Good Documentation Procedures, and Medical Records
Chapter 22Seriousness, Expectedness, and Causality
Health Authority Guidance and Requirements
CIOMS I Assessment of Causality
Uppsala Monitoring Centre (WHO)
Judgment of Cases When Received Versus at the Time of Periodic Reporting and Signaling
Chapter 23Coding of Adverse Events and Drug Names
MedDRA
Standardized MedDRA Queries (SMQs)
Systematized Nomenclature of Medicine — Clinical Terms
Drug Names and Drug Dictionaries
Multiple Names and Name Changes
EudraVigilance Medicinal Product Dictionary
Chapter 24Expedited and Aggregate Reporting in Clinical Trials
United States Requirements for Expedited IND Reports
Expedited IND Reports (Alert Reports, 7-Day and 15-Day IND Reports)
Other Clinical Trial (IND) Reporting Issues
Expedited Reporting in Clinical Trials
Development Safety Update Reports