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 t...
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. 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? Correct Answer: 90 days
How many days does an IRB have to inform the FDA that it is reviewing different
types of FDA products? Correct Answer: 30 days
CCRP
,CCRP
How often must an IRB renew its registration? Correct Answer: 3 years
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
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) Correct
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) Correct 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
CCRP
,CCRP
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
2. Intervention presents experiences that are reasonable commensurate with normal
medical and living situations
3. Intervention is likely to yield generalizable knowledge that is vital
4. Assent + consent
Sponsors must report SAEs to the FDA within how many days of discovering the
event? Correct Answer: 15 calendar days (21 CFR 312.32)
Investigators must report SAEs to a sponsor within how many days of discovering
the event? Correct Answer: Immediately (21 CFR 312.64)
Sponsors must report what kind of serious events to the FDA within 15 calendar
days? (4) Correct Answer: 1) Serious and unexpected suspected adverse reactions
2) Findings from other studies that suggest a significant risk in humans
3) Findings from animal or in-vitro testing that suggest risks to humans
4) Increased rate of occurrence of serious suspected adverse reactions
Sponsors must submit Unanticipated Adverse Device Effects to the FDA within
how many days? Correct Answer: 10 working days (21 CFR 812.15)
Investigators must submit Unanticipated Adverse Device Effects to the FDA
within how many days? Correct Answer: 10 working days (21 CFR 812.15)
CCRP
, CCRP
When was the Nuremberg Code issued? Correct Answer: 1947
What are the 10 points made in the Nuremberg Code? Correct Answer: 1)
Voluntary informed consent should be obtained
2) Research should yield benefit to society
3) Research should be based on animal work
4) Avoid unnecessary suffering
5) Don't do research resulting in death or disabling injury
6) Risks should be justified by benefits
7) Proper prep and adequate facilities should be used
8) Conducted by scientifically qualified people
9) Subject can withdraw whenever
10) Researchers can end the study if risks are too great
When was the Declaration of Helsinki released? Correct Answer: 1964
Who developed the Declaration of Helsinki? Correct Answer: World Medical
Association (WMA)
What is the Declaration of Helsinki? Correct Answer: Document that laid out
general principles physicians should follow to conduct research with humans,
based on Nuremberg Code. First effort of medical community to regulate itself
CCRP
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