SOCRA Certification Questions and

SOCRA Certification Questions and Answers 100% Verified | Latest Update

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

• 3
• 5
• 6
• 10

Correct answer: B) 5

Question : 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

Correct answer: D ) All of the above

Question : 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

Correct answer: C) At least one member's primary area of

interest is in a nonscientific area

Question : 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

Question : 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

Correct answer: B) This subject should undergo all study

procedures as outlined in the protocol

Question : 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