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ACRP Certified Professional Exam Sample Questions (Q45-Q50):

NEW QUESTION # 45
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B. Training records of site personnel on study protocol, and their study-related duties and functions.
C. A monitoring report that identifies deviation from the approved protocol.
D. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.

Answer: B

NEW QUESTION # 46
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A. PI
B. Regulatory Agency
C. CRC
D. Sponsor

Answer: A

Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.

NEW QUESTION # 47
A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A. Reduce the target sample size based on feedback from the sites.
B. Re-train investigators on recruitment obligations.
C. Evaluate the screen failures to determine if the protocol needs revision.
D. Allocate additional monitoring resources to the trial.

Answer: C

Explanation:
The high rate of screen failures indicates that the inclusion/exclusion criteria may be too stringent or not appropriately defined. The sponsor should evaluate the reasons for these failures and determine whether the protocol needs adjustment. Revising the criteria may increase recruitment efficiency without compromising the scientific validity of the study.
GCP guidelines advise reviewing and possibly revising protocols when screen failure rates are significantly high to ensure feasible recruitment.
"If a high number of screen failures occurs, the sponsor should evaluate the inclusion/exclusion criteria and consider protocol revisions." Objectives:
* Improve recruitment efficiency.
* Adapt protocol criteria to real-world conditions.

NEW QUESTION # 48
While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

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

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for ensuring that any laboratory used for trial-related testing is appropriately qualified and certified. This includes verifying the laboratory's accreditation, quality control procedures, and ability to perform the required tests accurately. The PI must document the qualification process to ensure compliance with GCP and protocol requirements.
GCP guidelines state that the investigator is responsible for selecting and verifying the qualification of laboratories used in the study.
"The PI must ensure that any laboratory involved in the trial is properly qualified and capable of performing the specified tests according to protocol requirements." Objectives:
* Maintain quality control in laboratory testing.
* Ensure the accuracy and reliability of test results.

NEW QUESTION # 49
The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A. Verify subject eligibility
B. Schedule a site initiation visit
C. Ship/receive IP
D. Obtain IRB/IEC approval

Answer: D

Explanation:
Before proceeding with any trial-related activities, including subject screening, the site must first obtain IRB
/IEC approval. This approval ensures that the study has been reviewed for ethical considerations, risk assessment, and adherence to regulatory requirements. Without IRB/IEC approval, initiating the study would violate ethical guidelines and regulatory standards.
GCP guidelines mandate that no clinical trial procedures, including screening, commence without prior IRB
/IEC approval.
"IRB/IEC approval must be obtained before initiating any study-related activities, including screening and subject recruitment." Objectives:
* Ensure ethical compliance before study initiation.
* Protect participant rights and safety.

NEW QUESTION # 50
......

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