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ACRP Certified Professional Exam Sample Questions (Q17-Q22):

NEW QUESTION # 17
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A. Regulatory authority.
B. Medical monitor.
C. Sponsor.
D. IRB/IEC.

Answer: C

Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.

NEW QUESTION # 18
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
B. Meet with the site staff to understand their workflows and to review retention strategies.
C. Interview participants who have dropped out.
D. Require participants to provide documented reason for withdrawal.

Answer: B

Explanation:
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.

NEW QUESTION # 19
The coding system for a double-blind clinical trial is accessible by the:

A. PI
B. Sponsor
C. IRB/IEC
D. Regulatory authority

Answer: B

Explanation:
The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.
GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.
"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study's integrity." Objectives:
* Maintain the integrity of double-blind trials.
* Allow controlled access to randomization codes.

NEW QUESTION # 20
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A. Develop a monitoring plan
B. Conduct routine investigators' meetings
C. Draft a CAPA plan
D. Establish a DSMB/IDMC

Answer: D

Explanation:
A Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) is established to review ongoing trial data at regular intervals. The DSMB evaluates safety, progress, and efficacy endpoints and makes recommendations to continue, modify, or terminate the study based on interim data. This independent oversight helps ensure participant safety and data integrity throughout the trial.
GCP guidelines recommend forming a DSMB for studies that involve high risks or long durations, ensuring continuous safety monitoring.
"The DSMB is responsible for the periodic review of accumulating data and providing recommendations regarding trial continuation, modification, or termination." Objectives:
* Ensure ongoing safety evaluation.
* Facilitate objective decisions on trial continuation.

NEW QUESTION # 21
The sponsor should supply a PI with the IP after:

A. Submission of documents to IRB/IEC and regulatory authority for review.
B. Approval of protocol by the PI.
C. Approval of protocol by the sponsor.
D. Approval/favorable opinion from IRB/IEC and regulatory authority.

Answer: D

Explanation:
The sponsor may only provide the investigational product (IP) after the IRB/IEC and relevant regulatory authorities have approved the protocol. This ensures that the trial complies with ethical and legal standards before initiating IP administration.
According to GCP guidelines, sponsors must wait for all necessary approvals before distributing IP to the trial site.
"The investigational product may only be supplied after obtaining regulatory and IRB/IEC approval to ensure ethical conduct of the trial." Objectives:
* Ensure regulatory compliance before initiating IP distribution.
* Protect participant safety and ethical standards.

NEW QUESTION # 22
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