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ACRP-CP Practice Questions

ACRP Certified Professional Exam

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Total Questions : 125

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Question # 11

A serious unexpected ADR is one:

Options:

A.  

Severity and nature of the reaction is consistent with protocol.

B.  

Where the severity of the reaction is not consistent with I

B.  

C.  

That does not need to be reported to the IRB/IE

C.  

D.  

That results in the death of the subject.

Discussion 0
Question # 12

A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year, 150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

Options:

A.  

Re-train investigators on recruitment obligations.

B.  

Allocate additional monitoring resources to the trial.

C.  

Reduce the target sample size based on feedback from the sites.

D.  

Evaluate the screen failures to determine if the protocol needs revision.

Discussion 0
Question # 13

All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

Options:

A.  

Identifying potential study risks.

B.  

Documenting all possible risk scenarios.

C.  

Assessing risk based on study impact.

D.  

Controlling risk by setting thresholds of risk acceptability.

Discussion 0
Question # 14

Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

Options:

A.  

Protocol, informed consent, and clinical trial agreement

B.  

IB, site coordinator CVs, and information about payments and compensation available to subjects

C.  

Protocol, IB, and information about payments and compensation available to subjects

D.  

Protocol, site coordinator CVs, and clinical trial agreement

Discussion 0
Question # 15

A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

Options:

A.  

A signed clinical trial agreement between the site and sponsor is in place.

B.  

The site receives approval from the medical monitor to begin enrolling.

C.  

The DSMB meets and the first DSMB meeting report has been issued.

D.  

The CRA has performed source document review and verification at the site.

Discussion 0
Question # 16

Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

Options:

A.  

CRA

B.  

CRO

C.  

Sponsor

D.  

Data Manager

Discussion 0
Question # 17

While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services. Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

Options:

A.  

PI

B.  

CRC

C.  

CRO

D.  

Sponsor

Discussion 0
Question # 18

A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

Options:

A.  

Original

B.  

Complete

C.  

Attributable

D.  

Contemporaneous

Discussion 0
Question # 19

Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

Options:

A.  

Regulatory submission of protocol and accompanying documents to relevant regulatory authority.

B.  

A monitoring report that identifies deviation from the approved protocol.

C.  

A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

D.  

Training records of site personnel on study protocol, and their study-related duties and functions.

Discussion 0
Question # 20

After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

Options:

A.  

No approval is necessary: give the diary to each subject.

B.  

Submit the diary to the sponsor for approval.

C.  

Submit the diary to the regulatory authority for approval.

D.  

Submit the diary to the IRB/IEC for approval.

Discussion 0
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