CCRP UPDATED ACTUAL QUESTIONS AND CORRECT ANSWERS VERIFIED
2027 EDITION
1. 21 CFR 11
Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures
2. 21 CFR 50
Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General
50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of
Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children
3. 21 CFR 50 Subpart B
50.25 Elements of Informed Consent
4. 21 CFR 50 Subpart D
Additional Safeguards for Children
5. 21 CFR 54
Financial Disclosure by Clinical Investigators
6. 21 CFR 56
Institutional Review Boards B - Organization and Personnel 56.106 - Registration 56.107 - Membership C -
Functions & Operations 56.108 - Functions & Operations D - Records/Reports 56.115 - IRB Records
7. 21 CFR 56 Subpart B
Organization & Personnel 56.106 - Registration 56.107 - Membership
8. 21 CFR 56 Subpart C
Functions & Operations 56.108 - Functions/Operations
9. 21 CFR 312
Investigational New Drug Application B - Investigational New Drug Application D - Responsibilities of
Sponsors & Investigators E - Drugs Intended to Treat Life-Threatening and Severely Debilitating Illnesses I
- Expanded Access to Investigational Drugs for Treatment Use
10. 21 CFR 812
Investigational Device Exemptions
11. 45 CFR 46
Public Welfare (Common Rule) A - Basic HHS Policy for Protection of Human Research Subjects 46.116 -
General Requirements for Informed Consent 46.117 - Documentation of Informed Consent B - Additional
Protections for Pregnant Women/Human Fetuses/Neonates C - Additional Protections for
Biomedical/Behavioral Research involving Prisoners as Subjects 46.304 - composition of IRBs where
prisoners are involved D - Additional Protections for Children
12. 45 CFR 46 Subpart A
Basic HHS policy for Protection of Human Research Subjects 46.116 - General Requirements for Informed
Consent 46.117 - Documentation of Informed Consent
13. 45 CFR 46 Subpart B
Additional protections for pregnant women, human fetuses, and neonates, involved in research
1
,14. 45 CFR 46 Subpart C
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.304 - composition of IRBs where prisoners are involved
15. 45 CFR 46 Subpart D
Additional Protections for Children
16. FDA Form 482
Notice of Inspection
17. FDA Form 483
Inspectional Observations
18. FDA Form 1571
Cover Sheet for IND Applications
19. FDA Form 1572
Statement of Investigator
20. FDA Form 3454
Certification - Financial Interests and Arrangements of Clinical Investigators
21. FDA Form 3455
Disclosure - Financial Interests and Arrangements of Clinical Investigators
22. FDA Form 3500
For Voluntary Reporting of Adverse Events and Product Problems
23. FDA Form 3500A
For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting
24. Belmont Report
1976 respect for persons - autonomy (informed consent) beneficence (risk/benefit analysis) justice
(appropriate selection of patients) no specific recommendations for admin action distinction between
research/practice applications: informed consent (incl. information and incomplete disclosure,
comprehension, voluntariness), risk/benefits, selection
25. Nuremberg Code
1947 voluntary consent essential, benefits > risks 1) voluntary consent 2) fruitful results for good of society
3) based on results of animal experiments, knowledge of natural history of disease (anticipated results will
justify experiment) 4) avoid unnecessary suffering 5) no reason to believe death/disability 6) degree of risk
doesn't exceed humanitarian importance 7) proper reparations, adequate facilities 8) scientifically
qualified 9) can withdraw at any time 10) scientist can terminate at any time if believes risk of injury/death
26. What's the minimum number of IRB members?
5
27. 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? a) the investigator provides written approval b) the
study drug has an FDA approved marketing application c) the FDA provides written approval of the
IND d) cannot be enrolled until IRB/IEC approval
cannot be enrolled until IRB/IEC approval
2
, 28. The responsibility for ensuring that the investigator understands a clinical trial lies with:
sponsor
29. A subject has been enrolled on a study and was randomized to the non-treatment arm. The
protocol outlines study procedures for all subjects to be performed within one week of enrollment.
Which is correct: a) subject doesn't need to undergo procedures since on non-tx arm b) should
undergo all procedures outlined in protocol c) only needs to undergo procedures pertaining
specifically to subject d) can undergo procedures when convenient
should undergo all study procedures as outlined in protocol
30. Significant risk device
An investigational device that a) is intended as an implant and presents a potential for serious risk to the
health, safety or welfare of the subject b) is purposed or represented to be for a use in supporting or
sustaining human life and presents a potential serious risk c) is for a use of substantial importance in
diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health.
31. With respect to IRB/IEC membership, both the FDA and the ICH require that: a) a majority of the
members' primary area of interest is in a scientific area b) at least one member holds PhD or
equivalent c) at least one member's primary area of interest is nonscientific d) a majority are from or
have ties to the institution
at least one member's primary area of interest is nonscientific
32. A purpose of monitoring clinical trials is to verify that: a) The rights, safety, and well-being of
human subjects are protected b) Investigators receive adequate payment for their participation in the
clinical trial c) The investigator has received annual reports from the sponsor d) The regulatory agency
has received all case history information of subjects enrolled on the clinical trial
a) The rights, safety, and well-being of human subjects are protected
33. Proper way to correct CRF: a) Completely blacken the incorrect entry and then enter the correct
information b) Back date the corrected entry with the date of the original entry c) Initial using the
initials of the sponsor's representative who reviewed the change d) Add the initials of the person
making the change, the date of the change, and, if necessary, a brief explanation of the change
d) Add the initials of the person making the change, the date of the change, and, if necessary, a brief
explanation of the change
34. Declaration of Helsinki
1964, World Medical Association (WMA) ethical principles for medical research involving human subjects
international research ethics research combined with clinical care, non-therapeutic research
35. Informed consent will be sought from each prospective subject or the subject's
Legally authorized representative
36. An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk,
but not less than _ per year.
once
37. Research may receive approval if there is a minority of the IRB members present at the convened
meeting (T/F)
false
38. Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of one
gender, profession
3
2027 EDITION
1. 21 CFR 11
Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures
2. 21 CFR 50
Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General
50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of
Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children
3. 21 CFR 50 Subpart B
50.25 Elements of Informed Consent
4. 21 CFR 50 Subpart D
Additional Safeguards for Children
5. 21 CFR 54
Financial Disclosure by Clinical Investigators
6. 21 CFR 56
Institutional Review Boards B - Organization and Personnel 56.106 - Registration 56.107 - Membership C -
Functions & Operations 56.108 - Functions & Operations D - Records/Reports 56.115 - IRB Records
7. 21 CFR 56 Subpart B
Organization & Personnel 56.106 - Registration 56.107 - Membership
8. 21 CFR 56 Subpart C
Functions & Operations 56.108 - Functions/Operations
9. 21 CFR 312
Investigational New Drug Application B - Investigational New Drug Application D - Responsibilities of
Sponsors & Investigators E - Drugs Intended to Treat Life-Threatening and Severely Debilitating Illnesses I
- Expanded Access to Investigational Drugs for Treatment Use
10. 21 CFR 812
Investigational Device Exemptions
11. 45 CFR 46
Public Welfare (Common Rule) A - Basic HHS Policy for Protection of Human Research Subjects 46.116 -
General Requirements for Informed Consent 46.117 - Documentation of Informed Consent B - Additional
Protections for Pregnant Women/Human Fetuses/Neonates C - Additional Protections for
Biomedical/Behavioral Research involving Prisoners as Subjects 46.304 - composition of IRBs where
prisoners are involved D - Additional Protections for Children
12. 45 CFR 46 Subpart A
Basic HHS policy for Protection of Human Research Subjects 46.116 - General Requirements for Informed
Consent 46.117 - Documentation of Informed Consent
13. 45 CFR 46 Subpart B
Additional protections for pregnant women, human fetuses, and neonates, involved in research
1
,14. 45 CFR 46 Subpart C
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.304 - composition of IRBs where prisoners are involved
15. 45 CFR 46 Subpart D
Additional Protections for Children
16. FDA Form 482
Notice of Inspection
17. FDA Form 483
Inspectional Observations
18. FDA Form 1571
Cover Sheet for IND Applications
19. FDA Form 1572
Statement of Investigator
20. FDA Form 3454
Certification - Financial Interests and Arrangements of Clinical Investigators
21. FDA Form 3455
Disclosure - Financial Interests and Arrangements of Clinical Investigators
22. FDA Form 3500
For Voluntary Reporting of Adverse Events and Product Problems
23. FDA Form 3500A
For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting
24. Belmont Report
1976 respect for persons - autonomy (informed consent) beneficence (risk/benefit analysis) justice
(appropriate selection of patients) no specific recommendations for admin action distinction between
research/practice applications: informed consent (incl. information and incomplete disclosure,
comprehension, voluntariness), risk/benefits, selection
25. Nuremberg Code
1947 voluntary consent essential, benefits > risks 1) voluntary consent 2) fruitful results for good of society
3) based on results of animal experiments, knowledge of natural history of disease (anticipated results will
justify experiment) 4) avoid unnecessary suffering 5) no reason to believe death/disability 6) degree of risk
doesn't exceed humanitarian importance 7) proper reparations, adequate facilities 8) scientifically
qualified 9) can withdraw at any time 10) scientist can terminate at any time if believes risk of injury/death
26. What's the minimum number of IRB members?
5
27. 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? a) the investigator provides written approval b) the
study drug has an FDA approved marketing application c) the FDA provides written approval of the
IND d) cannot be enrolled until IRB/IEC approval
cannot be enrolled until IRB/IEC approval
2
, 28. The responsibility for ensuring that the investigator understands a clinical trial lies with:
sponsor
29. A subject has been enrolled on a study and was randomized to the non-treatment arm. The
protocol outlines study procedures for all subjects to be performed within one week of enrollment.
Which is correct: a) subject doesn't need to undergo procedures since on non-tx arm b) should
undergo all procedures outlined in protocol c) only needs to undergo procedures pertaining
specifically to subject d) can undergo procedures when convenient
should undergo all study procedures as outlined in protocol
30. Significant risk device
An investigational device that a) is intended as an implant and presents a potential for serious risk to the
health, safety or welfare of the subject b) is purposed or represented to be for a use in supporting or
sustaining human life and presents a potential serious risk c) is for a use of substantial importance in
diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health.
31. With respect to IRB/IEC membership, both the FDA and the ICH require that: a) a majority of the
members' primary area of interest is in a scientific area b) at least one member holds PhD or
equivalent c) at least one member's primary area of interest is nonscientific d) a majority are from or
have ties to the institution
at least one member's primary area of interest is nonscientific
32. A purpose of monitoring clinical trials is to verify that: a) The rights, safety, and well-being of
human subjects are protected b) Investigators receive adequate payment for their participation in the
clinical trial c) The investigator has received annual reports from the sponsor d) The regulatory agency
has received all case history information of subjects enrolled on the clinical trial
a) The rights, safety, and well-being of human subjects are protected
33. Proper way to correct CRF: a) Completely blacken the incorrect entry and then enter the correct
information b) Back date the corrected entry with the date of the original entry c) Initial using the
initials of the sponsor's representative who reviewed the change d) Add the initials of the person
making the change, the date of the change, and, if necessary, a brief explanation of the change
d) Add the initials of the person making the change, the date of the change, and, if necessary, a brief
explanation of the change
34. Declaration of Helsinki
1964, World Medical Association (WMA) ethical principles for medical research involving human subjects
international research ethics research combined with clinical care, non-therapeutic research
35. Informed consent will be sought from each prospective subject or the subject's
Legally authorized representative
36. An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk,
but not less than _ per year.
once
37. Research may receive approval if there is a minority of the IRB members present at the convened
meeting (T/F)
false
38. Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of one
gender, profession
3
