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ACRP Certified Professional Exam Sample Questions (Q124-Q129):

NEW QUESTION # 124
During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A. Verify compliance with IP regimen.
B. Evaluate study data.
C. Conduct safety analysis.
D. Validate protocol endpoints.

Answer: A

Explanation:
Subject drug dosing diaries are essential for documenting adherence to the investigational product (IP) regimen. Incomplete or missing diaries compromise the ability to verify whether subjects followed the dosing schedule, which directly affects the trial's data integrity and the reliability of efficacy and safety assessments.
GCP guidelines stress the importance of maintaining accurate and complete dosing records to verify subject compliance with the protocol.
"Accurate documentation of dosing is essential to verify compliance with the investigational product regimen and ensure data accuracy." Objectives:
* Maintain accurate IP administration records.
* Ensure compliance monitoring throughout the study.

NEW QUESTION # 125
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?

A. Data Manager
B. CRA
C. CRO
D. Sponsor

Answer: D

Explanation:
The sponsor is responsible for establishing written procedures to ensure that all changes or corrections in Case Report Forms (CRFs) are properly documented and justified. These procedures must include who is authorized to make changes, how corrections are documented, and how they are endorsed by the investigator.
This practice ensures data accuracy and traceability.
GCP guidelines indicate that sponsors must establish and maintain procedures for data handling and documentation to ensure accuracy and reliability.
"The sponsor should develop written procedures to ensure that CRF changes are justified, documented, and endorsed by the investigator." Objectives:
* Maintain data accuracy and consistency.
* Ensure transparent documentation practices.

NEW QUESTION # 126
An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A. Investigator at each site
B. Original reporting investigator
C. Regulatory authority
D. Study sponsor

Answer: D

Explanation:
The study sponsor is responsible for disseminating information about SAEs to all participating sites. This ensures consistent and timely communication of safety concerns, allowing each site to take appropriate actions in line with local regulations and IRB/IEC requirements.
The answer aligns with ICH E6(R2) GCP guidelines which mandate the sponsor to communicatesafety information to all investigators and sites involved in a multicenter trial.
"The sponsor must inform all investigators of safety information that could affect the conduct of the trial or the safety of subjects." Objectives:
* Maintain consistent safety reporting across all trial sites.
* Ensure regulatory compliance in multicenter trials.

NEW QUESTION # 127
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A. Investigator
B. CRO
C. IRB/IEC
D. Sponsor

Answer: D

Explanation:
The sponsor is responsible for defining, establishing, and allocating all trial-related duties and functions before the trial begins. This includes outlining roles and responsibilities in collaboration with investigators, CROs, and other stakeholders. Proper delegation ensures the trial is conducted according to protocol and regulatory requirements.
This answer is verified based on GCP guidelines, which clearly state that sponsors are responsible for the organization and management of trial-related tasks.
"The sponsor is responsible for allocating duties and functions related to the conduct of the trial, ensuring compliance with regulatory and ethical standards." Objectives:
* Clarify the sponsor's role in clinical trial management
* Define responsibilities in trial planning

NEW QUESTION # 128
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

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

Answer: A

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 # 129
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