Clinical Research Coordinator
Liberty University
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Exam (elaborations)
Clinical Research Coordinator Exam| 245 QUESTIONS| WITH COMPLETE SOLUTIONS
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--63April 20232022/2023A+Available in bundle
- ADR correct answer: Adverse Drug Reaction _ relationship between IP and AE is at least reasonably possible 
life threatening ADR reported to reg agencies within 7 days. 
 
Unexpected Adverse drug Reaction correct answer: Severity not consistent with IP information 
Serious UAE (non life threatening) must be reported to regulators within 15 days. 
 
seriousness vs severity correct answer: seriousness is based on outcome usually life threat 
Severity is intensity of specific event (severe head...
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