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CCRP SOCRA EXAM 2023 WITH OVER 270 QUESTIONS AND ANSWERS LATEST UPDATE 2024
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CCRP SOCRA EXAM 2023 WITH OVER 270 QUESTIONS AND ANSWERS LATEST UPDATE 2024
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CCRP SOCRA EXAM 2023 WITH OVER 270ACTUAL QUESTIONS AND VERIFIED
ANSWERS
1. The responsibility for ensuring that the investigator understands a clinical trial lies
with which individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator: C) Sponsor
2. What is the minimum number of IRB Members?
D) 10: B) 5
3. A significant risk device is defined as an investigational device that is:
A) Intended as an implant and presents a potential for serious risk to the health, safety,
or welfare of a subject
B) Purported or represented to be for a use in supporting or sustaining human life and
presents a potential risk to the health, safety, or welfare of a subject
C) For a use of substantial importance in diagnosing, curing, mitigating, or treating
disease, or otherwise preventing impairment of human health and presents a potential
for serious risk to the health, safety, or welfare of a subject.
D) All the above: D ) All of the above
4. With respect to IRB/IEC membership, both the FDA and the ICH require that:
A) A majority of the members' primary area of interest is in a scientific area
B) At least one member holds a Ph.D. degree or equivalent
C) At least one member's primary area of interest is in a nonscientific area
,D) A majority of the members are from or have ties to the institution of record: C) At
least one member's primary area of interest is in a nonscientific area 5. In a non-
emergency situation, under which of the following conditions, if any, may subjects
been rolled into a study prior to IRB/IEC approval?
A) The investigator provides his/her written approval
B) The study drug has an FDA approved marketing application
C) The FDA provides written approval of the IND
D) Subjects cannot be enrolled until IRB/IEC approval has been obtained: D)
Subjects cannot be enrolled until IRB/IEC approval has been obtained
6. A subject has been enrolled on a study and was randomized to the non-treatment arm.
The protocol outlines study procedures for all subjects to be performed within one week
of enrollment. Which of the following statements about this case is correct?
A) This subject does not need to undergo any of the study procedures since the
subject is enrolled on the non-treatment arm
B) This subject should undergo all study procedures as outlined in the proto-col
C) This subject only needs to undergo the study procedures that pertain specifically to
the subject
D) This subject can undergo the study procedures whenever it is convenient-: B) This
subject should undergo all study procedures as outlined in the protocol 7. A
purpose of monitoring clinical trials is to verify that:
A) The rights, safety, and well-being of human subjects are protected
B) Investigators receive adequate payment for their participation in the clinical
trial
C) The investigator has received annual reports from the sponsor
,D) The regulatory agency has received all case history information of subjects enrolled
on the clinical trial: A) The rights, safety, and well-being of human subjects are
protected
8. Which of the following is the proper way to make a correction to a CRF?
A) Completely blacken the incorrect entry and then enter the correct informa-tion
B) Back date the corrected entry with the date of the original entry
C) Initial using the initials of the sponsor's representative who reviewed the change
D) Add the initials of the person making the change, the date of the change, and, if
necessary, a brief explanation of the change: D) Add the initials of the person
making the change, the date of the change, and, if necessary, a brief explanation of
the change 9. True or False:
The objective of the ICH GCP Guideline is to provide a unified standard for the European
Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical
data by the regulatory authorities in these jurisdictions.: True 10. The contents of a
Protocol should generally contain:
A) Trial objectives and purpose
B) Assessment of efficacy
C) Data handling and record keeping
D) All of the above
E) Only A & C: D) All of the above 11. True or False:
Only the principle investigator is allowed to transcribe data from the source document to
the CRF?: False
Why:
12. True or False:
When a short form is used for Informed Consent, the witness must sign either the short
form or the summary.: False
, Why: They must sign both
13. Form___________ is the investigator statement.
A) 1571
B) 1572
C) 3500
D) 3500A: B) 1572
14. What is 45 CFR Part 46?
A) HHS - Protection of Human Subjects
B) FDA - Protection of Human Subjects
C) HHS - Protection of Children
D) HHS - Protection of Research Participants: A) HHS - Protection of Human Subjects
Explanation: 45 CFR Part 46 covers the HHS (Health and Human Services) standards of
protection of human subjects. Also referred to as Public Welfare.
15. True or False:
The Code of Federal Regulations that applies to Investigational New Drug Applications
is 21CFR812.: False
INDs are covered in 21 CFR 312
16. Who monitors the progress of all clinical trial investigations being conducted under
an IND?
A) Principal Investigator
B) IRB
C) Sponsor
D) CRO: C) Sponsor
17. The World Medical 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
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