Clinical Research Coordinator Certification Exam – Questions & Answers (100% Correct)

Clinical Research Coordinator Certification Exam – Questions & Answers (100% Correct) Clinical Research Coordinator Certification Exam – Questions & Answers (100% Correct) ADR - 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 - ANSWER - Severity not consistent with IP information Serious UAE (non life threatening) must be reported to regulators within 15 days. seriousness vs severity - ANSWER - seriousness is based on outcome usually life threat Severity is intensity of specific event (severe headache) SAE miniumum info - ANSWER - Pt Details IP Con Meds SAE details Reporter name Sponsor details Audit - ANSWER - systematic examination of a company's accounting system to determine whether its financial reports reliably represent its operations clinical trials - ANSWER - experiments that study the effectiveness of medical treatments on Human Subjects compliance - ANSWER - Adherence to all study related requirements confidentiality - ANSWER - prevent (unauthorized) disclosure of pt info OR sponsor info Coordinating investigator - ANSWER - coordinates investigators at different centers for a mulit-center trial. Nonclinical Study - ANSWER - Biomedical studies not performed on human subjects. protocol - ANSWER - includes objective, design, methodology, statistical considerations, and trial organization.