9/17/25, 10:41 AM SOCRA CCRP Exam Questions
SOCRA CCRP Certification Practice Exam 1 2025/2026 Actual
Complete Real Exam Questions & Correct Well Elaborated
Answers |100% Verified solutions | Already Verified Test |
Already Graded A+ / 2025-2026 Brand New Exam!!
What is 45 CFR Part 46? A) HHS - Protection of Human Subjects
A) HHS - Protection of Human Explanation: 45 CFR Part 46 covers the HHS (Health and
Subjects Human Services) standards of protection of human
B) FDA - Protection of Human
subjects. Also referred to as Public Welfare.
Subjects
C) HHS - Protection of Children
D) HHS - Protection
of Research
Participants
True or False: False
The Code of Federal INDs are covered in 21 CFR 312
Regulations that applies
to Investigational New
Drug Applications is
21CFR812.
Who monitors the progress of C) Sponsor
all clinical
trial investigations being
conducted under an IND?
A) Principal Investigator
B) IRB
C) Sponsor
D) CRO
/ 1/46
,9/17/25, 10:55 AM CCRP SOCRA Exam - Practice Exam #1
The World Medical D) The Declaration of Helsinki
Association (WMA)
ethical principles for
medical research
involving human
subjects is called:
A) The Belmont Report
B) The National Research Act
C) The Nuremberg Code
D) The Declaration of Helsinki
The Code of Federal D) 21 CFR 56
Regulations that
applies to Institutional Review
Boards is:
A) 45CFR46
B) 21CFR312
C) 21CFR50
D) 21CFR56
The international ethical and B) Good Clinical Practices (GCP)
scientific
quality standard for
designing, conducting,
recording and reporting
trials that involve the
participation of human
subjects is known as:
A) The ICH
B) Good Clinical Practices
(GCP)
C) The Declaration of Helsinki
D) Fundamental Ethical
Principles (FEP)
/ 2/46
,9/17/25, 10:55 AM CCRP SOCRA Exam - Practice Exam #1
This form is used for the C) 3500
voluntary
reporting of adverse events Reminder: 3500 is for voluntary; 3500A is for mandatory
and product problems:
A) 1571
B) 1572
C) 3500
D) 3500A
Each IRB that reviews D) 21CFR Part 56, Sub part D
studies involving children
as subjects is covered by:
A) 21CFR Part 56, Sub part A
B) 21CFR Part 56, Sub part B
C) 21CFR Part 50, Sub part C
D) 21CFR Part 56, Sub part D
This form is used for the D) 3500A
mandatory reporting of
serious adverse events:
A) 1571
B) 1572
C) 3500
D) 3500A
/ 3/46
, 9/17/25, 10:55 AM CCRP SOCRA Exam - Practice Exam #1
What is covered in 21CFR50 A) Informed consent of Human Subjects
Subpart B?
A) Informed consent of Human
Subjects
B) IRB Functions and Operations
C) Records and Reports
D) Additional Safeguards
for Children in Clinical
Investigations
True or False: True
The IRB must determine that Explanation: According to 45 CFR 46 and 21 CFR 50.55
requirements for permission
by parents or guardians and
assent by children are
met.
What topic is covered in 45 D) None of the above
CFR 46 Subpart B?
A) Additional Safeguards and
Protections
B) Additional Protection for
Prisoners and Vulnerable
Subjects
C) Additional Protection for
Children and Unborn
Fetuses
D) None of the above
The clinical investigator will B) 1 Year
update the financial
disclosure information if
any relevant changes
occur during
the investigation's course and
for _______ following the
study's completion.
A) 6 months
/ 4/46
SOCRA CCRP Certification Practice Exam 1 2025/2026 Actual
Complete Real Exam Questions & Correct Well Elaborated
Answers |100% Verified solutions | Already Verified Test |
Already Graded A+ / 2025-2026 Brand New Exam!!
What is 45 CFR Part 46? A) HHS - Protection of Human Subjects
A) HHS - Protection of Human Explanation: 45 CFR Part 46 covers the HHS (Health and
Subjects Human Services) standards of protection of human
B) FDA - Protection of Human
subjects. Also referred to as Public Welfare.
Subjects
C) HHS - Protection of Children
D) HHS - Protection
of Research
Participants
True or False: False
The Code of Federal INDs are covered in 21 CFR 312
Regulations that applies
to Investigational New
Drug Applications is
21CFR812.
Who monitors the progress of C) Sponsor
all clinical
trial investigations being
conducted under an IND?
A) Principal Investigator
B) IRB
C) Sponsor
D) CRO
/ 1/46
,9/17/25, 10:55 AM CCRP SOCRA Exam - Practice Exam #1
The World Medical D) The Declaration of Helsinki
Association (WMA)
ethical principles for
medical research
involving human
subjects is called:
A) The Belmont Report
B) The National Research Act
C) The Nuremberg Code
D) The Declaration of Helsinki
The Code of Federal D) 21 CFR 56
Regulations that
applies to Institutional Review
Boards is:
A) 45CFR46
B) 21CFR312
C) 21CFR50
D) 21CFR56
The international ethical and B) Good Clinical Practices (GCP)
scientific
quality standard for
designing, conducting,
recording and reporting
trials that involve the
participation of human
subjects is known as:
A) The ICH
B) Good Clinical Practices
(GCP)
C) The Declaration of Helsinki
D) Fundamental Ethical
Principles (FEP)
/ 2/46
,9/17/25, 10:55 AM CCRP SOCRA Exam - Practice Exam #1
This form is used for the C) 3500
voluntary
reporting of adverse events Reminder: 3500 is for voluntary; 3500A is for mandatory
and product problems:
A) 1571
B) 1572
C) 3500
D) 3500A
Each IRB that reviews D) 21CFR Part 56, Sub part D
studies involving children
as subjects is covered by:
A) 21CFR Part 56, Sub part A
B) 21CFR Part 56, Sub part B
C) 21CFR Part 50, Sub part C
D) 21CFR Part 56, Sub part D
This form is used for the D) 3500A
mandatory reporting of
serious adverse events:
A) 1571
B) 1572
C) 3500
D) 3500A
/ 3/46
, 9/17/25, 10:55 AM CCRP SOCRA Exam - Practice Exam #1
What is covered in 21CFR50 A) Informed consent of Human Subjects
Subpart B?
A) Informed consent of Human
Subjects
B) IRB Functions and Operations
C) Records and Reports
D) Additional Safeguards
for Children in Clinical
Investigations
True or False: True
The IRB must determine that Explanation: According to 45 CFR 46 and 21 CFR 50.55
requirements for permission
by parents or guardians and
assent by children are
met.
What topic is covered in 45 D) None of the above
CFR 46 Subpart B?
A) Additional Safeguards and
Protections
B) Additional Protection for
Prisoners and Vulnerable
Subjects
C) Additional Protection for
Children and Unborn
Fetuses
D) None of the above
The clinical investigator will B) 1 Year
update the financial
disclosure information if
any relevant changes
occur during
the investigation's course and
for _______ following the
study's completion.
A) 6 months
/ 4/46
