CCRP EXAMINATION TEST PACK 2026
COMPLETE SOLUTIONS AND VERIFIED
ANSWERS
⩥ 21 CFR 50. Answer: 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
⩥ 21 CFR 50 Subpart B. Answer: 50.25 Elements of Informed Consent
⩥ 21 CFR 50 Subpart D. Answer: Additional Safeguards for Children
⩥ 21 CFR 54. Answer: Financial Disclosure by Clinical Investigators
⩥ 21 CFR 56. Answer: 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
⩥ 21 CFR 56 Subpart B. Answer: Organization & Personnel
56.106 - Registration
56.107 - Membership
⩥ 21 CFR 56 Subpart C. Answer: Functions & Operations
56.108 - Functions/Operations
⩥ 21 CFR 312. Answer: 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
⩥ 21 CFR 812. Answer: Investigational Device Exemptions
⩥ 45 CFR 46. Answer: 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
, ⩥ 45 CFR 46 Subpart A. Answer: Basic HHS policy for Protection of
Human Research Subjects
46.116 - General Requirements for Informed Consent
46.117 - Documentation of Informed Consent
⩥ 45 CFR 46 Subpart B. Answer: Additional protections for pregnant
women, human fetuses, and neonates, involved in research
⩥ 45 CFR 46 Subpart C. Answer: Additional Protections Pertaining to
Biomedical and Behavioral Research Involving Prisoners as Subjects
46.304 - composition of IRBs where prisoners are involved
⩥ 45 CFR 46 Subpart D. Answer: Additional Protections for Children
⩥ FDA Form 482. Answer: Notice of Inspection
⩥ FDA Form 483. Answer: Inspectional Observations
⩥ FDA Form 1571. Answer: Cover Sheet for IND Applications
⩥ FDA Form 1572. Answer: Statement of Investigator
COMPLETE SOLUTIONS AND VERIFIED
ANSWERS
⩥ 21 CFR 50. Answer: 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
⩥ 21 CFR 50 Subpart B. Answer: 50.25 Elements of Informed Consent
⩥ 21 CFR 50 Subpart D. Answer: Additional Safeguards for Children
⩥ 21 CFR 54. Answer: Financial Disclosure by Clinical Investigators
⩥ 21 CFR 56. Answer: 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
⩥ 21 CFR 56 Subpart B. Answer: Organization & Personnel
56.106 - Registration
56.107 - Membership
⩥ 21 CFR 56 Subpart C. Answer: Functions & Operations
56.108 - Functions/Operations
⩥ 21 CFR 312. Answer: 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
⩥ 21 CFR 812. Answer: Investigational Device Exemptions
⩥ 45 CFR 46. Answer: 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
, ⩥ 45 CFR 46 Subpart A. Answer: Basic HHS policy for Protection of
Human Research Subjects
46.116 - General Requirements for Informed Consent
46.117 - Documentation of Informed Consent
⩥ 45 CFR 46 Subpart B. Answer: Additional protections for pregnant
women, human fetuses, and neonates, involved in research
⩥ 45 CFR 46 Subpart C. Answer: Additional Protections Pertaining to
Biomedical and Behavioral Research Involving Prisoners as Subjects
46.304 - composition of IRBs where prisoners are involved
⩥ 45 CFR 46 Subpart D. Answer: Additional Protections for Children
⩥ FDA Form 482. Answer: Notice of Inspection
⩥ FDA Form 483. Answer: Inspectional Observations
⩥ FDA Form 1571. Answer: Cover Sheet for IND Applications
⩥ FDA Form 1572. Answer: Statement of Investigator
