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100% Pass ACRP - ACRP-CP - ACRP Certified Professional Exam Newest Latest Exam Labs

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ACRP Certified Professional Exam Sample Questions (Q120-Q125):

NEW QUESTION # 120
Which of the following is a conflict of interest for a PI conducting a study?

A. A PI who is a key opinion leader, writes the protocol
B. A PI that presents at an investigator meeting
C. A PI who receives payment for the study
D. A PI that votes on the IRB/IEC approval of the protocol

Answer: D

Explanation:
A Principal Investigator (PI) who is involved in voting on the IRB/IEC approval of their own protocol is considered to have a conflict of interest. The IRB/IEC must be independent and impartial when reviewing research proposals. Allowing the PI to vote on their own study compromises the ethical review process. To maintain unbiased decision-making, PIs must recuse themselves from such votes.
GCP guidelines emphasize the importance of avoiding conflicts of interest in the IRB/IEC decision-making process to maintain objectivity and ethical standards.
"A PI should not participate in voting or decision-making processes regarding the approval of their own study to avoid conflicts of interest." Objectives:
* Maintain impartiality in ethical review.
* Prevent conflicts of interest during IRB/IEC processes.

NEW QUESTION # 121
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

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

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 # 122
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

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

Answer: D

NEW QUESTION # 123
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

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

Answer: B

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 # 124
A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A. Complete
B. Contemporaneous
C. Original
D. Attributable

Answer: A

Explanation:
The missing data indicates a lack of completeness in the study documentation. Completeness is a fundamental requirement in clinical trials, as all necessary information must be recorded accurately and in full. Missing vital signs such as heart rate and temperature can compromise the validity of the data and affect the study's outcomes.
GCP guidelines state that all data collected during the study must be complete, accurate, and consistent with source documents.
"Clinical trial documentation must be complete, containing all data as required by the protocol toensure data integrity." Objectives:
* Ensure comprehensive data recording.
* Maintain accuracy and completeness in study records.

NEW QUESTION # 125
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