MEGA SOCRA CCRP EXAM CONTENT 790

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MEGA SOCRA CCRP EXAM CONTENT| 790

QUESTIONS (100 PAGES)| WITH COMPLETE

SOLUTION

Question 1: The minimum number of IRB members

CORRECT ANSWER : 5

Question 2: In a non-emergency situation, under which of the

following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?Subjects cannot be enrolled until IRB/IEC approval has been obtained

CORRECT ANSWER : Subjects cannot be enrolled until

IRB/IEC approval has been obtained

Question 3: The responsibility for ensuring that the investigator

understands a clinical trial lies with:

CORRECT ANSWER : The Sponsor

Question 4: 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

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week of enrollment. Which of the following statements about this case is correct?

CORRECT ANSWER : This subject should undergo all study

procedures as outlined in the protocol

Question 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.

CORRECT ANSWER : a, b, and c

Question 6: With respect to IRB/IEC membership, both the

FDA and the ICH require that

CORRECT ANSWER : At least one member's primary area of

interest is in a nonscientific area

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Question 7: A purpose of monitoring clinical trials is to verify

that:

CORRECT ANSWER : The rights, safety, and well-being of

human subjects are protected

Question 8: Which of the following is the proper way to make a

correction to a CRF?

CORRECT ANSWER : Add the initials of the person making the

change, the date of the change, and, if necessary, a brief explanation of the change

Question 9: What details need to be documented in the subject

source documentation when an Adverse Event (AE) occurs?Select all that apply

• The severity of the event
• When the event occurred
• Setting in which the event occurred

CORRECT ANSWER : A, B, and C

Question 10: What is an Unexpected Adverse drug reaction?

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CORRECT ANSWER : A reaction that is not consistent with the

applicable product information

Question 11: The terms "serious" and "severe" are synonymous according to ICH.

CORRECT ANSWER : FALSE

Question 12: A serious adverse event is any untoward medical

occurrence which at any dose is best described by which of the following statements? Select all that apply

• Results in death
• Is life-threatening
• Is a congenital anomaly

CORRECT ANSWER: A, B, and C

Question 13: Which of the following options describes the term

"severe" in regards to ICH?

CORRECT ANSWER : The Intensity of a specific event

Question 14: Subject 3826 had to stay in the hospital for three

extra days when his legs started swelling after participation in a