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ACRP Certified Professional Exam Sample Questions (Q35-Q40):

NEW QUESTION # 35
A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A. They cannot be the PI on the clinical study due to conflict of interest.
B. They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
C. They can attend the meeting and can vote/provide opinion on whether to approve the study.
D. They can attend the meeting, but should not vote/provide opinion on whether to approve the study.

Answer: B

Explanation:
If a PI is also a member of the IRB/IEC, they must recuse themselves from the meeting when their own study is being reviewed to avoid conflicts of interest. This practice preserves the objectivity and impartiality of the IRB/IEC's decisions.
The answer is verified based on IRB/IEC operational guidelines, which mandate that members with potential conflicts recuse themselves from discussions and voting.
"To maintain objectivity, IRB/IEC members who have a conflict of interest related to a study must recuse themselves from the review and decision-making process." Objectives:
* Maintain impartiality in IRB/IEC decisions
* Prevent conflicts of interest in clinical trial approval

NEW QUESTION # 36
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A. Update the IB to add the risk of infection and submit to the sponsor for approval.
B. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
C. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
D. Add the risk of infection to the ICF and submit to the IRB/IEC for review.

Answer: C

Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection." Objectives:
Ensure prompt reporting of safety concerns.
Maintain compliance with ethical oversight requirements.

NEW QUESTION # 37
Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A. 2.6 mg/dL
B. 1.8 mg/dL
C. 3.0 mg/dL
D. 3.6 mg/dL

Answer: C

Explanation:
To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.
1.2 x 2.5 = 3.0 mg/dL
Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg
/dL.
GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.
"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity." Objectives:
* Maintain accurate interpretation of laboratory criteria.
* Ensure compliance with protocol-defined inclusion/exclusion criteria.

NEW QUESTION # 38
A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A. 3 participants
B. 4 participants
C. 5 participants
D. 6 participants

Answer: A

Explanation:
Since the protocol specifies that participants withdrawn due to an Adverse Event (AE) should not bereplaced, only the participants withdrawn for noncompliance (3 in total) should be replaced. The participant who withdrew consent due to severe nausea (an AE) and the one who discontinued IP due to hospitalization should not be replaced.
GCP guidelines specify that replacement of subjects should follow the protocol criteria, particularly when AEs are involved.
"Participants withdrawn due to AEs should not be replaced if the protocol stipulates this condition, while noncompliant participants may be replaced." Objectives:
* Follow protocol guidelines for participant replacement.
* Ensure compliance with study criteria.

NEW QUESTION # 39
Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A. Sponsor
B. Monitor
C. Investigator
D. Coordinator

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all site staff involved in the study are adequately trained, even if they were unable to attend the Site Initiation Visit (SIV). This responsibility includes organizing training sessions or providing relevant training materials to maintain consistency and compliance with study protocols.
According to GCP guidelines, the PI must ensure that all staff members involved in the trial are adequately informed and trained on their specific responsibilities.
"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions." Objectives:
* Maintain consistent training for all clinical staff.
* Ensure compliance with study procedures.

NEW QUESTION # 40
......

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Practical ACRP-CP Information - Exam Topics ACRP-CP Pdf

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ACRP Certified Professional Exam Sample Questions (Q35-Q40):

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