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ACRP Certified Professional Exam Sample Questions (Q27-Q32):

NEW QUESTION # 27
The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A. Inform the monitor of the termination of the study.
B. Inform the IRB/IEC of the study closure.
C. Inform participant and assure proper care is provided.
D. Schedule participant for early termination visit.

Answer: C

Explanation:
When a study is temporarily suspended, the primary responsibility of the research team is to ensure the ongoing care and safety of the enrolled participants. Participants must be informed about the suspension and assured that their health and safety will continue to be monitored.
GCP guidelines prioritize the safety and well-being of participants, which must be maintained even during a temporary suspension.
"In the event of a study suspension, the first priority is to inform the participants and ensure that appropriate care and monitoring are continued." Objectives:
* Protect participant safety during study suspension.
* Maintain clear communication with study participants.

NEW QUESTION # 28
AEs that occur between study visits of a clinical trial should be evaluated by the:

A. Subject's primary care physician
B. Principal Investigator
C. Study pharmacovigilance physician
D. Medical monitor

Answer: B

Explanation:
The Principal Investigator (PI) is responsible for evaluating Adverse Events (AEs) that occur between study visits. The PI must assess the severity, causality, and potential relationship to the investigational product (IP).
Proper evaluation ensures that any necessary medical interventions are promptly administered and that relevant information is recorded and reported accurately.
GCP guidelines specify that the PI is accountable for the medical care of trial subjects, including evaluating AEs and ensuring their safety.
"The PI must evaluate any adverse events occurring between study visits to determine their relevance to the investigational product and manage patient care." Objectives:
* Ensure prompt and accurate evaluation of AEs.
* Maintain the safety and well-being of study participants.

NEW QUESTION # 29
A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A. 80%
B. 66%
C. 71%
D. 77%

Answer: D

Explanation:
Step 1:Calculate the total number of tablets dispensed:
* Month 1: 35 tablets
* Month 2: 35 tablets
* Total: 70 tablets
Step 2:Calculate the number of tablets returned:
* Month 1: 10 tablets
* Month 2: 12 tablets
* Total: 22 tablets
Step 3:Calculate the number of tablets taken:
* 70 - 22 = 48 tablets
Step 4:Calculate compliance:
* Compliance = (Tablets Taken / Total Tablets) × 100
* Compliance = (48 / 62) × 100 # 77%
GCP guidelines require accurate calculation of compliance based on returned IP counts, ensuring proper dose administration monitoring.
"Compliance rates are calculated by comparing the number of tablets taken to the total number of tablets dispensed, considering the returned count." Objectives:
* Monitor compliance with IP administration.
* Ensure accurate calculation of adherence rates.

NEW QUESTION # 30
Which one of the following is a primary objective of a Phase III study of a new IP?

A. To establish dose information
B. To demonstrate or confirm therapeutic benefit
C. To show superiority over another treatment
D. To establish the safety profile

Answer: B

Explanation:
Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.
According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.
"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments." Objectives:
* Confirm therapeutic efficacy.
* Provide comprehensive safety data.

NEW QUESTION # 31
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?

A. Submit the diary to the sponsor for approval.
B. Submit the diary to the regulatory authority for approval.
C. Submit the diary to the IRB/IEC for approval.
D. No approval is necessary: give the diary to each subject.

Answer: C

Explanation:
Any new data collection tool introduced during a clinical trial, including subject diaries, must be reviewed and approved by the IRB/IEC before implementation. This ensures that the new tool is ethically appropriate, respects subject privacy, and aligns with the approved protocol.
This answer aligns with ICH E6(R2) GCP guidelines, which mandate IRB/IEC approval for any new or modified subject-related documents introduced during a trial.
"All changes in study documents, including subject diaries, must be submitted for IRB/IEC review to ensure compliance with ethical standards." Objectives:
* Maintain compliance with IRB/IEC requirements.
* Ensure ethical handling of subject data.

NEW QUESTION # 32
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