CCRP Actual Questions with Detailed Answers

CCRP Actual Questions with Detailed Answers

Question 1.
21 CFR 11

Correct Answer: Electronic Records; Electronic Signatures B - Electronic Records
C - Electronic Signatures


Question 2.
21 CFR 50

Correct Answer: Protection of Human Subjects/Informed Consent B - Informed
Consent 50.23 - Exception from General 50.24 - Exception from Informed
Consent Requirements for Emergency Re- search 50.25 - Elements of Informed
Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards
for Children


Question 3.
21 CFR 50 Subpart B

Correct Answer: 50.25 Elements of Informed Consent


Question 4.
21 CFR 50 Subpart D

Correct Answer: Additional Safeguards for Children


Question 5.
21 CFR 54

Correct Answer: Financial Disclosure by Clinical Investigators


Question 6.
21 CFR 56

Correct 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


Question 7.
21 CFR 56 Subpart B

Correct Answer: Organization & Personnel 56.106 - Registration 56.107 -
Membership

,Question 8.
21 CFR 56 Subpart C

Correct Answer: Functions & Operations 56.108 - Functions/Operations


Question 9.
21 CFR 312

Correct 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


Question 10.
21 CFR 812

Correct Answer: Investigational Device Exemptions


Question 11.
45 CFR 46

Correct 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


Question 12.
45 CFR 46 Subpart A

Correct Answer: Basic HHS policy for Protection of Human Research Subjects
46.116 - General Requirements for Informed Consent 46.117 - Documentation of
Informed Consent


Question 13.
45 CFR 46 Subpart B

Correct Answer: Additional protections for pregnant women, human fetuses, and
neonates, involved in research

,Question 14.
45 CFR 46 Subpart C

Correct Answer: Additional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects 46.304 - composition of IRBs where
prisoners are involved


Question 15.
45 CFR 46 Subpart D

Correct Answer: Additional Protections for Children


Question 16.
FDA Form 482

Correct Answer: Notice of Inspection


Question 17.
FDA Form 483

Correct Answer: Inspectional Observations


Question 18.
FDA Form 1571

Correct Answer: Cover Sheet for IND Applications


Question 19.
FDA Form 1572

Correct Answer: Statement of Investigator


Question 20.
FDA Form 3454

Correct Answer: Certification - Financial Interests and Arrangements of Clinical
Investigators


Question 21.
FDA Form 3455

Correct Answer: Disclosure - Financial Interests and Arrangements of Clinical
Investigators

, Question 22.
FDA Form 3500

Correct Answer: For Voluntary Reporting of Adverse Events and Product
Problems


Question 23.
FDA Form 3500A

Correct Answer: For Use by User-Facilities, Distributors, and Manufacturers for
Mandatory Reporting


Question 24.
Belmont Report

Correct Answer: 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


Question 25.
Nuremberg Code

Correct Answer: 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


Question 26.
What's the minimum number of IRB members?

Correct Answer: 5