Clinical Research Coordinator Exam| 245 QUESTIONS| WITH COMPLETE SOLUTIONS
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 headache) SAE miniumum info correct answer: Pt Details IP Con Meds SAE details Reporter name Sponsor details Audit correct answer: systematic examination of a company's accounting system to determine whether its financial reports reliably represent its operations clinical trials correct answer: experiments that study the effectiveness of medical treatments on Human Subjects compliance correct answer: Adherence to all study related
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clinical research coordinator exam| 245 questions| with complete solutions
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