Free SOCRA SOCRA-CCRP Exam Questions

Become SOCRA Certified with updated SOCRA-CCRP exam questions and correct answers

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Total 131 Questions | Updated On: Apr 27, 2026

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Question 1

For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?

A : You might experience adverse events of myalgia, arthralgia, and lethargy

B : You might have some muscle aches, joint pain, and tiredness

C : You might develop symptoms of myalgia, arthralgia, and tiredness

D : You might have some mild side effects while taking the investigational drug

Answer: B

Question 2

According to the ICH GCP Guidelines, what is the purpose of source documents?

A : To establish diverse subject enrollment

B : To validate insurance reimbursement

C : To provide a record of subjects investigational medical treatment

D : To validate reports submitted to the IRB/IEC

Answer: C

Question 3

In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:

A : Written information to be provided to the subjects

B : Requirements for storage of the investigational product

C : Sponsor's SOPs

D : IRB/IEC requirements for reporting to the regulatory authority

Answer: D

Question 4

In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

A : 6 months

B : 12 months

C : 24 months

D : 36 months

Answer: B

Question 5

An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to noti

A : The IRB/IEC

B : The Data Safety Monitoring Board (DSMB)

C : The regulatory authority

D : No notification is required

Answer: D

Page: 1 / 27

Total 131 Questions | Updated On: Apr 27, 2026

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