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ACRP-CP Practice Questions

ACRP Certified Professional Exam

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Total Questions : 125

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Question # 21

A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

Options:

A.  

Placebo

B.  

No treatment

C.  

Active control

D.  

Alternate dose

Discussion 0
Question # 22

Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

Options:

A.  

CRO

B.  

Subject

C.  

PI

D.  

Sponsor

Discussion 0
Question # 23

Which strategy is used to safeguard subject privacy?

Options:

A.  

Store source documentation in the CRC's office.

B.  

Email updated enrollment logs to the CR

A.  

C.  

Utilize subject initials on correspondence.

D.  

Conduct subject-related conversations in controlled environments.

Discussion 0
Question # 24

A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

Options:

A.  

Phase I

B.  

Phase II

C.  

Phase III

D.  

Phase IV

Discussion 0
Question # 25

A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

Options:

A.  

Decline the study.

B.  

Use a central IRB/IE

C.  

C.  

Rely on the sponsor to notify the IRB/IE

C.  

D.  

Recruit for the study without use of social media.

Discussion 0
Question # 26

The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

Options:

A.  

7 calendar days

B.  

8 calendar days

C.  

15 calendar days

D.  

30 calendar days

Discussion 0
Question # 27

AEs that occur between study visits of a clinical trial should be evaluated by the:

Options:

A.  

Subject's primary care physician

B.  

Principal Investigator

C.  

Medical monitor

D.  

Study pharmacovigilance physician

Discussion 0
Question # 28

After the completion or termination of a clinical trial, who should store the enrollment log?

Options:

A.  

PI

B.  

CRO

C.  

Sponsor

D.  

Regulatory authority

Discussion 0
Question # 29

In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

Options:

A.  

A total of five members.

B.  

One member whose primary area of interest is in the same scientific area.

C.  

One member of the site's QA group.

D.  

One member who is independent of the institution/trial site.

Discussion 0
Question # 30

In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

Options:

A.  

PI

B.  

IRB/IEC

C.  

CRA

D.  

CRC

Discussion 0
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