CCRP SOCRA Exam - Practice Exam 1

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization?

A) FDA

B) IRB

• Sponsor
• Coordinator - answer C) Sponsor

What is the minimum number of IRB Members?

• 3
• 5
• 6
• 10 - answer B) 5

A significant risk device is defined as an investigational device that is:

• Intended as an implant and presents a potential for serious risk to the health, safety,

or welfare of a subject

• 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

• 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.

• All the above - answer D ) All of the above

With respect to IRB/IEC membership, both the FDA and the ICH require that:

• A majority of the members' primary area of interest is in a scientific area
• At least one member holds a Ph.D. degree or equivalent
• At least one member's primary area of interest is in a nonscientific area
• A majority of the members are from or have ties to the institution of record - answer
• At least one member's primary area of interest is in a nonscientific area

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?

• The investigator provides his/her written approval 1 / 2

• The study drug has an FDA approved marketing application
• The FDA provides written approval of the IND
• Subjects cannot be enrolled until IRB/IEC approval has been obtained - answer
• Subjects cannot be enrolled until IRB/IEC approval has been obtained

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?

• This subject does not need to undergo any of the study procedures since the subject

is enrolled on the non-treatment arm

• This subject should undergo all study procedures as outlined in the protocol
• This subject only needs to undergo the study procedures that pertain specifically to

the subject

• This subject can undergo the study procedures whenever it is convenient - answer
• This subject should undergo all study procedures as outlined in the protocol

A purpose of monitoring clinical trials is to verify that:

• The rights, safety, and well-being of human subjects are protected
• Investigators receive adequate payment for their participation in the clinical trial
• The investigator has received annual reports from the sponsor
• The regulatory agency has received all case history information of subjects enrolled

on the clinical trial - answer A) The rights, safety, and well-being of human subjects are protected Which of the following is the proper way to make a correction to a CRF?

• Completely blacken the incorrect entry and then enter the correct information
• Back date the corrected entry with the date of the original entry
• Initial using the initials of the sponsor's representative who reviewed the change
• Add the initials of the person making the change, the date of the change, and, if

necessary, a brief explanation of the change - answer D) Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change

• / 2