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ACRP Certified Professional Exam Sample Questions (Q69-Q74):

NEW QUESTION # 69
A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A. The site receives approval from the medical monitor to begin enrolling.
B. A signed clinical trial agreement between the site and sponsor is in place.
C. The DSMB meets and the first DSMB meeting report has been issued.
D. The CRA has performed source document review and verification at the site.

Answer: B

Explanation:
Before a clinical trial site can begin enrolling participants, there must be a signed clinical trial agreement (CTA) between the site and the sponsor. This agreement outlines the responsibilities, financial arrangements, and expectations between both parties, ensuring that the trial is conducted in compliance with regulatory and ethical standards.
GCP guidelines require that a formal agreement be in place before trial initiation to protect the rights and obligations of both the sponsor and the site.
"Before subject enrollment can commence, the sponsor and site must finalize a clinical trial agreement, establishing legal and ethical commitments." Objectives:
* Ensure proper contractual arrangements before trial initiation.
* Protect legal rights and obligations of involved parties.

NEW QUESTION # 70
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A. Sponsor
B. CRO
C. Subject
D. PI

Answer: A

Explanation:
The sponsor is responsible for defining the criteria and procedures for subject withdrawal or discontinuation of consent. This includes specifying how data already collected will be handled and whether any follow-up is required. The procedures must be clearly outlined in the study protocol and communicated to the research team.
This answer follows GCP guidelines, which state that the sponsor must ensure that procedures for subject withdrawal are clearly defined and documented.
"The sponsor is responsible for defining procedures to be followed if a subject discontinues participation or withdraws consent, including handling of data collected prior to withdrawal." Objectives:
* Ensure transparent procedures for participant withdrawal.
* Maintain data integrity while respecting participant autonomy.

NEW QUESTION # 71
A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A. A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
B. A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
C. A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
D. A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population

Answer: D

Explanation:
Since both the investigator and the participant are unaware of the treatment assignment, the study is classified as double-blind. The study aims to establish the superiority of XYZ over ABC, making it a superiority study.
The use of masked IV bags confirms the double-blind design.
The answer is verified from GCP guidelines on blinding and superiority study designs.
"In double-blind studies, neither the participant nor the investigator knows the treatment assignment, which prevents bias." Objectives:
* Understanding blinding methods in clinical trials
* Ensuring unbiased efficacy comparisons

NEW QUESTION # 72
A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A. After the protocol amendment is approved by the IRB/IEC
B. When the need for the additional data is discovered
C. After the original planned data collection is completed
D. As soon as the protocol amendment is submitted to the IRB/IEC

Answer: A

Explanation:
The research team must wait until the protocol amendment is reviewed and approved by the IRB/IEC before collecting any additional data. This ensures that any changes to the data collection process have undergone ethical review and comply with regulatory requirements. Collecting data without IRB/IEC approval would be a violation of Good Clinical Practice (GCP).
GCP guidelines clearly state that any changes to the protocol, including additional data collection, must be approved by the IRB/IEC before implementation.
"Any amendment that affects participant data collection must receive IRB/IEC approval before the change is implemented." Objectives:
* Maintain compliance with ethical standards.
* Protect participants' rights and data integrity.

NEW QUESTION # 73
A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A. Investigator's Brochure
B. Clinical Monitoring Plan
C. Data & Safety Monitoring Plan
D. Standard Operating Procedure

Answer: D

Explanation:
The Standard Operating Procedure (SOP) outlines the process for shipping, storing, mixing, and transferring the investigational product (IP) between locations. SOPs ensure that all steps are consistently followed and documented, maintaining the integrity and quality of the IP throughout the handling process. This is critical for maintaining compliance with Good Clinical Practice (GCP) and ensuring patient safety.
GCP guidelines specify that SOPs should cover the handling, transfer, and storage of investigational products to ensure quality control.
"SOPs provide detailed guidance on the handling and transfer of investigational products to ensure consistency and compliance." Objectives:
* Maintain the integrity of IP during transport and handling.
* Ensure compliance through standardized procedures.

NEW QUESTION # 74
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