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ICH GCP for CCRC Exam Prep 100% SOLUTION
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 the use of a 
medicinal pro...
- Exam (elaborations)
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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 the use of a 
medicinal pro...