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2024 Newest |CCRP Exam| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE

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2024 Newest |CCRP Exam| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE 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 IR...

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Uploaded on November 11, 2024
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2024 Newest |CCRP Exam|2024-2025 UPDATE|COMPREHENSIVE
FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED
ANSWERS|GET IT 100% ACCURATE

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

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 1/63

,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

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 2/63

,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

What are the criteria for involving children in greater than minimal risk research with

no direct benefit? (4) - 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? - ANSWER✔✔-15 calendar days (21 CFR 312.32)

Investigators must report SAEs to a sponsor within how many days of discovering the

event? - ANSWER✔✔-Immediately (21 CFR 312.64)

Sponsors must report what kind of serious events to the FDA within 15 calendar days?

(4) - ANSWER✔✔-1) Serious and unexpected suspected adverse reactions

2) Findings from other studies that suggest a significant risk in humans

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 3/63

, 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? - ANSWER✔✔-10 working days (21 CFR 812.15)

Investigators must submit Unanticipated Adverse Device Effects to the FDA within

how many days? - ANSWER✔✔-10 working days (21 CFR 812.15)

When was the Nuremberg Code issued? - ANSWER✔✔-1947

What are the 10 points made in the Nuremberg Code? - 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

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 4/63

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Exam (elaborations)

2024 Newest |CCRP Exam| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE

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