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ACRP Certified Professional Exam Sample Questions (Q53-Q58):
NEW QUESTION # 53
After the site qualification visit report has been finalized, it must be:
- A. Stored in the sponsor's budgets and contracts file.
- B. Included in the PI's regulatory file.
- C. Sent to the IRB/IEC for review and approval.
- D. Kept in the CRO/sponsor's trial master file.
Answer: D
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 # 54
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?
- A. CRA
- B. PI
- C. CRC
- D. IRB/IEC
Answer: B
Explanation:
In investigator-initiated studies, the PI holds primary responsibility for addressing non-compliance, including root cause analysis and implementation of CAPA plans. This ensures that any issues affecting the study's integrity are adequately addressed and prevented in the future.
The answer is verified based on ICH E6(R2) guidelines which emphasize the PI's responsibility for maintaining compliance at the study site.
"The PI must develop and implement corrective and preventive actions when non-compliance is identified during the study." Objectives:
* Maintain compliance in investigator-initiated studies.
* Address non-compliance through CAPA.
NEW QUESTION # 55
A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?
- A. To establish a procedure for PI oversight of protocol deviations
- B. To escalate corrective actions to the regulatory authority
- C. To determine if a protocol amendment is needed
- D. To determine if the deviations invalidate the data
Answer: A
Explanation:
A Corrective and Preventive Action (CAPA) plan is implemented to address deviations and prevent them from recurring. In this context, the purpose of the CAPA is to establish a procedure for the Principal Investigator (PI) to ensure proper oversight of protocol deviations. This ensures that all future deviations are appropriately managed, reviewed, and documented according to GCP standards.
The answer is verified from GCP guidelines which emphasize that CAPA should focus on identifying root causes and establishing processes to prevent future deviations.
"A CAPA plan must address the root cause and implement systematic actions to prevent the recurrence of protocol deviations." Objectives:
* Ensuring PI oversight in protocol adherence
* Maintaining data integrity through systematic corrective actions
NEW QUESTION # 56
A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?
- A. Sponsor
- B. Monitor
- C. QA Department
- D. Data Manager
Answer: B
Explanation:
After data entry into the Electronic Data Capture (EDC) system, the monitor (typically a Clinical Research Associate - CRA) conducts Source Data Verification (SDV). The monitor compares the data entered in the EDC system with the source documents to ensure accuracy, completeness, and consistency. This step is essential for maintaining data integrity and compliance with GCP standards.
GCP guidelines require that monitors verify data accuracy through SDV as part of routine monitoring responsibilities.
"The monitor is responsible for performing Source Data Verification (SDV) to ensure that the data recorded in the EDC system matches the source documents." Objectives:
* Verify data accuracy in clinical trials.
* Ensure compliance with data management protocols.
NEW QUESTION # 57
A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?
- A. Crossover
- B. Parallel Group
- C. Factorial
- D. Group sequential
Answer: A
Explanation:
A crossover study design involves participants receiving multiple interventions sequentially, with a washout period in between to minimize carryover effects. This design allows each participant to serve as their own control, increasing statistical power while reducing variability. It is commonly used when comparing two treatments or interventions.
GCP guidelines classify a crossover design as one where subjects receive multiple treatments in a specified sequence.
"In crossover trials, participants receive each intervention in a specific order, allowing for within-subject comparison." Objectives:
* Understand the structure of crossover studies.
* Improve statistical efficiency through self-control comparisons.
NEW QUESTION # 58
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