PDF (New 2026) Actual ACRP ACRP-CP Exam Questions [Q48-Q64]

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PDF (New 2026) Actual ACRP ACRP-CP Exam Questions

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QUESTION 48
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

CRO

Subject

Sponsor

QUESTION 49
Who is responsible for the ongoing safety evaluation of the IP?

Regulatory agency

IRB/IEC

Sponsor

QUESTION 50
A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

Return all IP and request the CRO/Sponsor to directly ship IP to participants.

Invest in a room temperature controlled IP cabinet and transfer IP to this unit.

Continue reporting temperature excursions per the pharmacy manual guidelines.

Install an air cooler requiring regular water refills to maintain the room temperature.

QUESTION 51
A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

The site may proceed with the destruction of the essential documents.

The site should retain the essential documents longer to meet the regulatory requirements.

The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.

The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.

QUESTION 52
Which one of the following is a primary objective of a Phase III study of a new IP?

To establish the safety profile

To establish dose information

To demonstrate or confirm therapeutic benefit

To show superiority over another treatment

QUESTION 53
A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

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

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

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

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

QUESTION 54
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

7 calendar days

8 calendar days

15 calendar days

30 calendar days

QUESTION 55
A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

Clinical Study Protocol

Clinical Study Report

Investigator Brochure

IDMC/DSMB Report

QUESTION 56
A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

Crossover

Factorial

Group sequential

Parallel Group

QUESTION 57
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

IRB/IEC

CRA

CRC

QUESTION 58
Who is responsible for submitting a protocol amendment to the IRB/IEC?

Sponsor

CRC

Investigator

CRA

QUESTION 59
When assessing the monitoring needs for a study, sponsors should:

Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.

Use central monitoring instead of conducting physical monitoring visits at sites.

Permit PIs to select a monitor for their site as long as they are independent of the PI.

Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.

QUESTION 60
After the site qualification visit report has been finalized, it must be:

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

Included in the PI’s regulatory file.

Stored in the sponsor’s budgets and contracts file.

Sent to the IRB/IEC for review and approval.

QUESTION 61
All of the following are examples of what monitors review EXCEPT:

Regulatory binder which includes copies of current certifications for all laboratories.

The signed ICF retained in the participant’s study file.

Potential patient medical records for eligibility prior to the informed consent process.

Documentation in the participant’s medical record of study drug administration.

QUESTION 62
All site financial matters pertaining to a trial are listed in what document?

Signed contract

Financial disclosure

Informed consent form

Protocol

QUESTION 63
A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

Phase I

Phase II

Phase III

Phase IV

QUESTION 64
The sponsor should supply a PI with the IP after:

Approval of protocol by the sponsor.

Approval/favorable opinion from IRB/IEC and regulatory authority.

Submission of documents to IRB/IEC and regulatory authority for review.

Approval of protocol by the PI.

Updated Jan-2026 Pass ACRP-CP Exam – Real Practice Test Questions: https://www.test4cram.com/ACRP-CP_real-exam-dumps.html

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