CCRP EXAM QBANK 273

CCRP EXAM QBANK | 273

QUESTIONS AND ANSWERS

Question : How many days does a sponsor have to report an

emergency use of an IP to the FDA?

CORRECT ANSWER : 5 working days

Question : How many members must sit on an IRB?

CORRECT ANSWER : 5

Question : How long must an IRB retain records per 21 CFR

56?

CORRECT ANSWER : 3 years after completion of research

Question : What are the criteria for IRB approval of research?

(7)

CORRECT ANSWER : 1. Risks to subjects are minimized

• Risks are reasonable in relation to anticipated benefits
• Selection of subjects is equitable
• Informed consent will be sought from subjects or LARs

• Informed consent will be documented
• There is adequate provision of monitoring
• There is adequate provision to protect the privacy of

subjects

Question : How many days does an IRB have to report a

change in registration information due to a change in chairperson or contact?

CORRECT ANSW ER: 90 days

Question : How many days does an IRB have to inform the

FDA that it is reviewing different types of FDA products?

CORRECT ANSWER : 30 days

Question : How often must an IRB renew it's registration?

CORRECT ANSWER : 3 years

Question : What are the 8 basic elements of informed consent

per FDA guidelines?

CORRECT ANSWER : 1. Statement that the study involves

research, purpose and expected duration, description of experimental procedures

• Description of reasonably foreseeable risks
• Benefits
• Disclosure of alternative procedures or courses of treatment
• Confidentiality measures
• Compensation and treatments available if injury occurs
• contact information
• Participation is voluntary and subject may discontinue at

any time

Question : What are the criteria for involving children in

minimal risk research? (2)

CORRECT ANSWER : 1. No greater than minimal risk

• Assent from kid + consent from parent obtained

Question : What are the criteria for involving children in

greater than minimal risk research with prospect of benefit?(3)

CORRECT ANSWER : 1. Risks are justified by benefits

• Relation of anticipated benefit is at least as favorable as

that presented by alternative approaches

• Assent + consent

Question : What are the criteria for involving children in

greater than minimal risk research with no direct benefit? (4)

CORRECT ANSWER : 1. Risks are minor increase over

minimal risk

• Intervention presents experiences that are reasonable

commensurate with normal medical and living situations

• Intervention is likely to yield generalizable knowledge that

is vital

• Assent + consent

Question : Sponsors must report SAEs to the FDA within how

many days of discovering the event?

CORRECT ANSWER : 15 calendar days (21 CFR 312.32)