CCRN EXAM PREP
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CCRC Exam Prep - GCP E6(R2) Glossary Study Guide
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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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