E6r1 1 Study guides, Class notes & Summaries

ICH GCP for CCRC Exam Prep And Answers Last document update:   ago

ICH GCP for CCRC Exam Prep Adverse Drug Reaction (ADR) - Answer-All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 - Answer-Glossary of terms Adverse Event (AE) - Answer-Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment--any unfavorable and unintended sign , symptom, or disease temporally associated with th...