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ACRP Certified Professional Exam Sample Questions (Q82-Q87):

NEW QUESTION # 82
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A. Independent qualified individuals.
B. Regulatory authority expert advisors.
C. Executive board members.
D. Investigators participating in the trial.

Answer: A

Explanation:
Interim analysis should be reviewed by independent qualified individuals, such as members of a Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC). This ensures that the analysis is unbiased and that decisions regarding continuation, modification, or termination of the trial are made objectively.
GCP guidelines emphasize that interim data should be reviewed by an independent committee to prevent bias and ensure participant safety.
"Interim analyses should be conducted by independent experts to maintain objectivity and safeguard trial integrity." Objectives:
* Maintain impartiality during interim analysis.
* Ensure unbiased decision-making regarding trial continuation.

NEW QUESTION # 83
Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A. Sponsor
B. Investigator
C. Coordinator
D. Monitor

Answer: B

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all site staff involved in the study are adequately trained, even if they were unable to attend the Site Initiation Visit (SIV). This responsibility includes organizing training sessions or providing relevant training materials to maintain consistency and compliance with study protocols.
According to GCP guidelines, the PI must ensure that all staff members involved in the trial are adequately informed and trained on their specific responsibilities.
"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions." Objectives:
* Maintain consistent training for all clinical staff.
* Ensure compliance with study procedures.

NEW QUESTION # 84
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

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

Answer: D

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 # 85
Who must be blinded in a double-blind study in order to prevent bias?

A. Subject
B. IRB/IEC
C. Pharmacist
D. Data entry staff

Answer: A

Explanation:
In a double-blind study, both the participant (subject) and the investigator (or clinical staff administering the treatment) are blinded. This approach minimizes bias in treatment administration and outcome assessment.
Blinding the subject ensures that their responses are not influenced by their knowledge of the treatment they are receiving.
According to GCP guidelines, double-blinding is essential to eliminate both participant and investigator bias, ensuring objective trial results.
"Double-blind studies ensure that neither the participant nor the investigator knows which intervention is being administered, thereby minimizing bias." Objectives:
* Maintain the integrity of the study by preventing bias.
* Enhance the validity of trial outcomes.

NEW QUESTION # 86
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A. Consult with the IRB/IEC first.
B. Allow access to the entire records.
C. Redact subject identification for privacy protection.
D. Deny the request until the sponsor approves.

Answer: B

Explanation:
Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.
According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.
"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights." Objectives:
* Ensure compliance with inspection requirements.
* Maintain transparency with regulatory authorities.

NEW QUESTION # 87
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