SOCRA CCRP Certification Exam Bank 250 Multiple Choice Questions with ANSWER Key and Rational

SOCRA CCRP Certification Exam Bank 250 Multiple Choice
Questions with ANSWER Key and Rational


RESEARCH STUDY START-UP (Approximately 100 Questions)




QUESTION 1:
Which of the following is NOT one of the three major content areas on the SOCRA CCRP
certification examination?
A) Research Study Start-Up
B) Research Study Implementation
C) Research Study Closure
D) Research Study Data Analysis

ANSWER: D
Rationale: The CCRP exam is organized into three content areas: Research Study Start-Up
(40%), Research Study Implementation (45-50%), and Research Study Closure (10-15%).
Data analysis is not a separate content area but is covered within these domains.




QUESTION 2:
The CCRP certification examination consists of how many multiple-choice questions?
A) 100
B) 130

,C) 150
D) 200

ANSWER: B
Rationale: The exam contains 130 multiple-choice questions, of which 30 are beta test
questions that do not affect the candidate's score. The 100 scored questions determine the
final result.




QUESTION 3:
According to SOCRA, what is the minimum number of scored questions a candidate must
ANSWER correctly to pass the CCRP exam?
A) 50
B) 60
C) 71
D) 80

ANSWER: C
Rationale: Candidates must correctly ANSWER 71 out of the 100 scored questions to
achieve a passing score. The passing score is determined using the Modified Angoff
Method.




QUESTION 4:
Which of the following is the foundational document that introduced the requirement for
voluntary consent in human subjects research?
A) The Belmont Report
B) The Declaration of Helsinki
C) The Nuremberg Code
D) 45 CFR Part 46

,ANSWER: C
Rationale: The Nuremberg Code (1947) was the first international document to establish
the principle of voluntary informed consent as a requirement for human subjects research,
arising from the Nuremberg Trials.




QUESTION 5:
The Belmont Report established which three core ethical principles?
A) Respect for persons, beneficence, justice
B) Autonomy, non-maleficence, veracity
C) Confidentiality, integrity, objectivity
D) Safety, efficacy, quality

ANSWER: A
Rationale: The Belmont Report (1979) established three fundamental ethical principles for
research involving human subjects: respect for persons (autonomy), beneficence
(maximize benefits/minimize harms), and justice (fair distribution of burdens and benefits).




QUESTION 6:
Which regulation governs the protection of human subjects in clinical research conducted
or supported by the U.S. Department of Health and Human Services?
A) 21 CFR Part 50
B) 21 CFR Part 56
C) 45 CFR Part 46
D) 21 CFR Part 312

ANSWER: C
Rationale: 45 CFR Part 46 is the Common Rule that governs the protection of human
subjects in research conducted or supported by HHS and other federal agencies.

, QUESTION 7:
The federal regulation that addresses Institutional Review Boards is:
A) 21 CFR Part 50
B) 21 CFR Part 56
C) 21 CFR Part 312
D) 21 CFR Part 812

ANSWER: B
Rationale: 21 CFR Part 56 specifically addresses Institutional Review Boards, covering
their composition, function, operations, and review of research.



QUESTION 8:
Which CFR part governs investigational new drug applications?
A) 21 CFR Part 50
B) 21 CFR Part 56
C) 21 CFR Part 312
D) 21 CFR Part 812

ANSWER: C
Rationale: 21 CFR Part 312 regulates Investigational New Drug (IND) applications, covering
requirements for conducting clinical investigations with drugs and biological products.



QUESTION 9:
Which regulation applies to electronic records and electronic signatures in clinical
research?
A) 21 CFR Part 11
B) 21 CFR Part 50
C) 21 CFR Part 54
D) 21 CFR Part 812