CCRP Exam With Complete Solution

How many days does a sponsor have to report an emergency use of an IP to the FDA? - Answer 5 working days How many members must sit on an IRB? - Answer 5 How long must an IRB retain records per 21 CFR 56? - Answer 3 years after completion of research What are the criteria for IRB approval of research? (7) - Answer 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 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? - Answer 90 days How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products? - Answer 30 days How often must an IRB renew it's registration? - Answer 3 years What are the 8 basic elements of informed consent per FDA guidelines? - Answer 1. Statement that the study involves research, purpose and expected duration, description of experimental procedures 2. Description of reasonably foreseeable risks 3. Benefits 4. Disclosure of alternative procedures or courses of treatment 5. Confidentiality measures 6. Compensation and treatments available if injury occurs 7. contact information 8. Participation is voluntary and subject may discontinue at any time What are the criteria for involving children in minimal risk research? (2) - Answer 1. No greater than minimal risk 2. Assent from kid + consent from parent obtained What are the criteria for involving children in greater than minimal risk research with prospect of benefit? (3) - Answer 1. Risks are justified by benefits 2. Relation of anticipated benefit is at least as favorable as that presented by alternative approaches 3. Assent + consent