SOCRA QUESTIONS AND ANSWERS ALL

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SOCRA QUESTIONS AND ANSWERS ALL

CORRECT

Question 1: The responsibility for ensuring that the investigator

understands a clinical trial lies with which individual/or organization?

A) FDA

B) IRB

• Sponsor
• Coordinator

CORRECT ANSWER : C) Sponsor

Question 2: What is the minimum number of IRB Members?

• 3
• 5
• 6
• 10

CORRECT ANSWER : B) 5

A significant risk device is defined as an investigational device

that is:

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• 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

Question 3: A significant risk device is defined as an

investigational device that is:

CORRECT ANSWER: D) All of the above

Question 4: 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

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• A majority of the members are from or have ties to the

institution of record

CORRECT ANSWER : C) At least one member's primary area

of interest is in a nonscientific area

Question 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?

• The investigator provides his/her written approval
• 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

CORRECT ANSWER : D) 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.

Question 6: Which of the following statements about this case is

correct?

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• 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

CORRECT ANSWER : B) This subject should undergo all study

procedures as outlined in the protocol

Question 7: 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