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ACRP Certified Professional Exam Sample Questions (Q98-Q103):

NEW QUESTION # 98
A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A. They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
B. They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
C. They cannot be the PI on the clinical study due to conflict of interest.
D. They can attend the meeting and can vote/provide opinion on whether to approve the study.

Answer: A

Explanation:
If a PI is also a member of the IRB/IEC, they must recuse themselves from the meeting when their own study is being reviewed to avoid conflicts of interest. This practice preserves the objectivity and impartiality of the IRB/IEC's decisions.
The answer is verified based on IRB/IEC operational guidelines, which mandate that members with potential conflicts recuse themselves from discussions and voting.
"To maintain objectivity, IRB/IEC members who have a conflict of interest related to a study must recuse themselves from the review and decision-making process." Objectives:
* Maintain impartiality in IRB/IEC decisions
* Prevent conflicts of interest in clinical trial approval

NEW QUESTION # 99
Which one of the following is a primary objective of a Phase III study of a new IP?

A. To show superiority over another treatment
B. To establish the safety profile
C. To establish dose information
D. To demonstrate or confirm therapeutic benefit

Answer: D

Explanation:
Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.
According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.
"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments." Objectives:
* Confirm therapeutic efficacy.
* Provide comprehensive safety data.

NEW QUESTION # 100
After the site qualification visit report has been finalized, it must be:

A. Included in the PI's regulatory file.
B. Sent to the IRB/IEC for review and approval.
C. Kept in the CRO/sponsor's trial master file.
D. Stored in the sponsor's budgets and contracts file.

Answer: C

Explanation:
The finalized site qualification visit report must be maintained in the sponsor's trial master file (TMF) as part of the essential documents. The TMF serves as the repository for all documents that demonstrate compliance with the protocol and regulatory requirements. Storing the report in the TMF ensures traceability and documentation of the site's suitability for conducting the trial.
GCP guidelines require that site qualification visit reports be included in the trial master file to maintain comprehensive documentation of site assessments.
"Finalized site qualification visit reports must be stored in the sponsor's trial master file to ensure proper documentation and compliance." Objectives:
* Maintain documentation of site qualifications.
* Ensure compliance through comprehensive record-keeping.

NEW QUESTION # 101
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A. The number of unique eCRF templates was not specified.
B. The frequency of data backup was not defined.
C. The number of users with access was not defined.
D. The list of comparable technology solutions was not included.

Answer: B

Explanation:
The frequency of data backup is a critical element of an Electronic Data Capture (EDC) system's Standard Operating Procedure (SOP). Ensuring regular and systematic data backup is essential for protecting trial data against loss or corruption. Failure to specify backup frequency indicates a gap in data security management.
GCP guidelines stress that data protection, including regular backups, is essential to maintaining data integrity in clinical trials.
"EDC system SOPs must include clear guidelines on data backup frequency to safeguard the integrity and availability of study data." Objectives:
* Ensure data security through regular backups.
* Maintain data integrity in clinical research.

NEW QUESTION # 102
Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A. IRB/IEC
B. CRO
C. Sponsor-Investigator
D. Regulatory authority

Answer: C

Explanation:
In a multi-center clinical trial, the Sponsor-Investigator holds ultimate responsibility for the overall conduct of the study. This includes ensuring compliance with the protocol, maintaining data integrity, and overseeing all participating sites. The Sponsor-Investigator must ensure that each site follows the same procedures and standards to maintain consistency across the trial.
According to GCP guidelines, the Sponsor-Investigator must take responsibility for all aspects of a multi- center trial, including site coordination and data management.
"The Sponsor-Investigator assumes ultimate responsibility for the conduct of a multi-center clinical trial, ensuring protocol compliance and data consistency." Objectives:
* Maintain accountability across multi-center sites.
* Ensure uniformity in trial conduct.

NEW QUESTION # 103
......

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