Irb Study guides, Class notes & Summaries

CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024 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 heal...

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...

Certification for IRB Professionals (CIP) Exam Complete Q&A 2023. According to the Belmont Report, respect for persons usually demands that subjects... According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - A poorly designed protocol is considered unethical because... - When should an IRB suspend or terminate approval of research? - A quorum for a convened IRB meeting requires the pr...

According to the Belmont Report, respect for persons usually demands that subjects... enter into research voluntarily & with adequate information According to the Belmont Report, the moral requi rement that there be fair outcomes in the selection of research subjects, expresses the principle of: Justice A poorly designed protocol is considered unethical because... research subjects may be put at risk or inconvenienced for insufficient reason When should an IRB suspend or terminate approval of re...

MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) | Latest 2023/2024 5 ️ The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained ️ In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor ️ The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a s...

Certification for IRB Professionals (CIP) Exam Complete Questions & Answers-According to the Belmont Report, respect for persons usually demands that subjects... - enter into research voluntarily & with adequate information According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - Justice A poorly designed protocol is considered unethical because... - research subjects may be put at risk or inconv...

SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug presen...

Minimal Risk - The probability of harm or discomfort...not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations. The Belmont Principles -Respect for persons, beneficence, and justice IRB - An administrative body composed of scientists and nonscientists established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the inst...

CCRP Exam Questions Bank | 273 Questions with 100% Correct Answers How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answer 5 working days How many members must sit on an IRB? - correct answer 5 How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research What are the criteria for IRB approval of research? (7) - correct answer 1. Risks to subjects are minimized 2. Risks are reasonable in relation t...

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