CCRN EXAM PREP
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CCRN EXAM PREP 1
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Pre-Approved clincal experience - all noxious and unintended responses to a medical 
product related to any dose 
Marketed Medicinal products- a response to a drug which is noxious and unintended 
and which occurs at doess normally used. (ICH GCP E6 1.1) - Adverse Drug Reaction 
(ADR) 
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. (ICH GCP ...
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Pre-Approved clincal experience - all noxious and unintended responses to a medical 
product related to any dose 
Marketed Medicinal products- a response to a drug which is noxious and unintended 
and which occurs at doess normally used. (ICH GCP E6 1.1) - Adverse Drug Reaction 
(ADR) 
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. (ICH GCP ...