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ACRP-CP Practice Exam Questions and Answers

ACRP Certified Professional Exam

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Question # 1

Who on the local site research study team is accountable for the unblinding documentation of IP?

Options:

A.  

Regulatory manager

B.  

CRC

C.  

Pharmacist

D.  

PI

Discussion 0
Question # 2

Which one of the following is a primary objective of a Phase III study of a new IP?

Options:

A.  

To establish the safety profile

B.  

To establish dose information

C.  

To demonstrate or confirm therapeutic benefit

D.  

To show superiority over another treatment

Discussion 0
Question # 3

Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

Options:

A.  

Perform a periodic review to see if the quality methods are effective and relevant.

B.  

Train the research coordinator on the required study assessments schedule.

C.  

Determine the quality tolerance limits for data transcription errors.

D.  

Identify critical processes and data during protocol development.

Discussion 0
Question # 4

After the site qualification visit report has been finalized, it must be:

Options:

A.  

Kept in the CRO/sponsor's trial master file.

B.  

Included in the PI's regulatory file.

C.  

Stored in the sponsor's budgets and contracts file.

D.  

Sent to the IRB/IEC for review and approval.

Discussion 0
Question # 5

What would a sponsor use to implement and maintain quality in a study?

Options:

A.  

Standard operating procedures

B.  

Protocol signature pages

C.  

Clinical trial agreement

D.  

Statistical analysis plan

Discussion 0
Question # 6

A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

Options:

A.  

Reject the alternative hypothesis that the drug has no effect on cholesterol levels.

B.  

Reject the null hypothesis that the drug has no effect on cholesterol levels.

C.  

Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.

D.  

Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.

Discussion 0
Question # 7

Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

Options:

A.  

Investigator

B.  

CRO

C.  

Sponsor

D.  

CRC

Discussion 0
Question # 8

SAEs must be reported immediately by the site to the:

Options:

A.  

Sponsor.

B.  

Regulatory agency.

C.  

IRB/IE

C.  

D.  

DSMB/IDM

C.  

Discussion 0
Question # 9

Which document confirms the PI’s agreement to permit auditing at the study site?

Options:

A.  

IB

B.  

ICF

C.  

Protocol

D.  

Delegation Log

Discussion 0
Question # 10

In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

Options:

A.  

Investigator

B.  

CRA

C.  

Sponsor

D.  

CRC

Discussion 0
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