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ACRP Certified Professional Exam Sample Questions (Q50-Q55):

NEW QUESTION # 50
Which strategy is used to safeguard subject privacy?

A. Email updated enrollment logs to the CRA.
B. Conduct subject-related conversations in controlled environments.
C. Utilize subject initials on correspondence.
D. Store source documentation in the CRC's office.

Answer: B

Explanation:
Conducting subject-related conversations in controlled environments ensures that personal and sensitive information is not overheard or disclosed to unauthorized individuals. This practice upholds patient confidentiality as required by GCP and data protection regulations.
The answer follows GCP guidelines for protecting the privacy and confidentiality of clinical trial participants.
"Conversations regarding study subjects should be held in secure and controlled environments to protect personal data." Objectives:
* Ensuring confidentiality in clinical trial settings.
* Protecting patient privacy according to ethical standards.

NEW QUESTION # 51
A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

A. The site may proceed with the destruction of the essential documents.
B. The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
C. The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
D. The site should retain the essential documents longer to meet the regulatory requirements.

Answer: C

Explanation:
Before destroying any essential documents, the site must obtain written confirmation from the sponsor that these documents are no longer needed. This ensures compliance with regulatory requirements, as some countries may require document retention for longer periods, even after study closure and marketing approval.
GCP guidelines state that the sponsor must confirm in writing that essential documents can be destroyed after ensuring compliance with local regulations.
"Before destroying essential documents, written confirmation from the sponsor is required to ensure compliance with regulatory retention policies." Objectives:
* Maintain compliance with document retention regulations.
* Prevent premature destruction of essential trial records.

NEW QUESTION # 52
SAEs must be reported immediately by the site to the:

A. Sponsor.
B. IRB/IEC.
C. DSMB/IDMC.
D. Regulatory agency.

Answer: A

Explanation:
Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.
GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.
"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements." Objectives:
* Ensure rapid reporting of serious adverse events.
* Maintain safety monitoring during the trial.

NEW QUESTION # 53
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, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
B. A randomized, open-label, comparator 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, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population

Answer: A

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 # 54
A serious unexpected ADR is one:

A. That results in the death of the subject.
B. Severity and nature of the reaction is consistent with protocol.
C. That does not need to be reported to the IRB/IEC.
D. Where the severity of the reaction is not consistent with IB.

Answer: D

Explanation:
A serious unexpected adverse drug reaction (ADR) is characterized by an event that is not consistent with the information provided in the Investigator's Brochure (IB). Such reactions may indicate new risks associated with the investigational product and warrant immediate reporting to the sponsor and regulatory authorities.
This answer follows the ICH E6(R2) GCP guidelines, which specify the criteria for reporting serious and unexpected adverse events.
"An unexpected adverse drug reaction is one whose nature or severity is not consistent with the applicable product information (e.g., IB)." Objectives:
* Understanding classification of ADRs
* Ensuring timely and accurate reporting of unexpected events

NEW QUESTION # 55
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