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ACRP Certified Professional Exam Sample Questions (Q78-Q83):

NEW QUESTION # 78
Who must be blinded in a double-blind study in order to prevent bias?

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

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 # 79
During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A. Evaluate study data.
B. Validate protocol endpoints.
C. Verify compliance with IP regimen.
D. Conduct safety analysis.

Answer: C

Explanation:
Subject drug dosing diaries are essential for documenting adherence to the investigational product (IP) regimen. Incomplete or missing diaries compromise the ability to verify whether subjects followed the dosing schedule, which directly affects the trial's data integrity and the reliability of efficacy and safety assessments.
GCP guidelines stress the importance of maintaining accurate and complete dosing records to verify subject compliance with the protocol.
"Accurate documentation of dosing is essential to verify compliance with the investigational product regimen and ensure data accuracy." Objectives:
* Maintain accurate IP administration records.
* Ensure compliance monitoring throughout the study.

NEW QUESTION # 80
Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

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

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 # 81
AEs that occur between study visits of a clinical trial should be evaluated by the:

A. Subject's primary care physician
B. Study pharmacovigilance physician
C. Medical monitor
D. Principal Investigator

Answer: D

Explanation:
The Principal Investigator (PI) is responsible for evaluating Adverse Events (AEs) that occur between study visits. The PI must assess the severity, causality, and potential relationship to the investigational product (IP).
Proper evaluation ensures that any necessary medical interventions are promptly administered and that relevant information is recorded and reported accurately.
GCP guidelines specify that the PI is accountable for the medical care of trial subjects, including evaluating AEs and ensuring their safety.
"The PI must evaluate any adverse events occurring between study visits to determine their relevance to the investigational product and manage patient care." Objectives:
* Ensure prompt and accurate evaluation of AEs.
* Maintain the safety and well-being of study participants.

NEW QUESTION # 82
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 # 83
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