CCRP Exam with Questions and
Answers/100% Correct/ Grade A+
21 CFR 11 - ✔✔Electronic Records; Electronic Signatures
B - Electronic Records
C - Electronic Signatures
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
21 CFR 50 Subpart B - ✔✔50.25 Elements of Informed Consent
,21 CFR 50 Subpart D - ✔✔Additional Safeguards for Children
21 CFR 54 - ✔✔Financial Disclosure by Clinical Investigators
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
21 CFR 56 Subpart B - ✔✔Organization & Personnel
56.106 - Registration
56.107 - Membership
,21 CFR 56 Subpart C - ✔✔Functions & Operations
56.108 - Functions/Operations
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
21 CFR 812 - ✔✔Investigational Device Exemptions
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
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
45 CFR 46 Subpart B - ✔✔Additional protections for pregnant women, human fetuses, and
neonates, involved in research
45 CFR 46 Subpart C - ✔✔Additional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
Answers/100% Correct/ Grade A+
21 CFR 11 - ✔✔Electronic Records; Electronic Signatures
B - Electronic Records
C - Electronic Signatures
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
21 CFR 50 Subpart B - ✔✔50.25 Elements of Informed Consent
,21 CFR 50 Subpart D - ✔✔Additional Safeguards for Children
21 CFR 54 - ✔✔Financial Disclosure by Clinical Investigators
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
21 CFR 56 Subpart B - ✔✔Organization & Personnel
56.106 - Registration
56.107 - Membership
,21 CFR 56 Subpart C - ✔✔Functions & Operations
56.108 - Functions/Operations
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
21 CFR 812 - ✔✔Investigational Device Exemptions
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
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
45 CFR 46 Subpart B - ✔✔Additional protections for pregnant women, human fetuses, and
neonates, involved in research
45 CFR 46 Subpart C - ✔✔Additional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
