CCRP (CCRP)

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...

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 ...

5 Correct Answer: The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: 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 Correct Answer: The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. T...

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 CF R 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 consent w...

Timeline of Historical Events Correct Answer: Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report Correct Answer: respect for persons, beneficence, justice Application of Respect for Persons Correct Answer: informed consent (autonomy, choose for themselves) Application of Beneficence Correct Answer: risk/benefit analysis Application of Justice Correct Answer: appropriate selection of patients (equality) Language Le...

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. ...

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 Exam Questions Bank | 273 Questions with 100% Correct Answers

When isn't an IND application needed? Correct Answer: IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) Correct Answer: FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug depende...