Cra exam - Study guides, Class notes & Summaries

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Creat 0.5-1.2...

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - Answer - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will con...

NURS 6521 Midterm Exam 2023 Walden University NURS 6521 Midterm Exam: Advanced Pharmacology: Walden University (FOR 100% CORRECT ANSWER CHECK THE LAST PAGE) 1. Which of the following patients demonstrates the clearest indication for treatment with prednisone? A) A 66-year-old woman whose history of smoking has culminated in a diagnosis of emphysema B) A 70-year-old man whose rheumatoid arthritis has not responded to OTC pain relievers C) A 12-year-old boy whose long-standing fatigue...

CRA EXAM PRACTICE QUESTIONS AND ANSWERS

CRA EXAM DETAIL QUESTIONS AND ANSWERS

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CRA Exam with Complete Solutions

CRA exam 1 study guide questions & answers 2024/2025 Institutional Biosafety Committee - ANSWERSmandated for the oversight of research involving recombinant DNA 2 CFR 215 (OMB Circular A-110) - ANSWERSprovides regulations governing Administrative requirements for grants and cooperative agreements for educational institutions 2 CFR 220 (OMB Circular A-21) - ANSWERSPurpose is to establish principles for determining costs applicable to grants, contracts, & other agreements with education...

CRA EXAM - TERMS

CCRP SOCRA Exam - Practice Exam 1 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject B) P...