CCRP (CCRP)

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - ANS Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANS Determining that the study has a maximization of benefits and a minimization of risks. Which...

s to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed consent will be documented 6. There is adequate provision of monitoring 7. There is adequate provision to protect the privacy of subjects How many days does an IRB have to report a change in registration information due to a change in chairperson or contact? - 90 days How many days does an IRB have to in...

CCRP Final Exam Questions With Complete 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 to anticipated benefits 3. ...

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? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed ...