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ACRP Certified Professional Exam Sample Questions (Q33-Q38):
NEW QUESTION # 33
Which of the following statements is TRUE about an EDC system?
- A. There should be an audit trail to track data entries, deletions, and changes.
- B. A separate workstation should be made available for the monitor.
- C. IRB/IEC approval is required before the use of the computerized system.
- D. The eCRF should be an exact page-by-page replica of the paper CRF.
Answer: A
Explanation:
An Electronic Data Capture (EDC) system must include an audit trail to ensure data integrity. This audit trail records every data entry, modification, and deletion along with timestamps and user identification. It is a critical feature for maintaining traceability and accountability in clinical research, allowing for the reconstruction of data changes and ensuring compliance with Good Clinical Practice (GCP).
GCP guidelines mandate that electronic data systems used in clinical trials must maintain an audit trail to ensure data integrity and traceability.
"An audit trail is essential in an EDC system to document all data entries, changes, and deletions to maintain data integrity." Objectives:
* Ensure data integrity through traceable record-keeping.
* Maintain compliance with regulatory standards.
NEW QUESTION # 34
Who must be blinded in a double-blind study in order to prevent bias?
- A. IRB/IEC
- B. Subject
- C. Pharmacist
- D. Data entry staff
Answer: B
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 # 35
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
- A. Central monitoring of data fields by sponsor
- B. Pre-qualification assessment of CRO
- C. Risk-based audits of CRO activities as delegated
- D. Co-monitoring of CRO site visits
Answer: C
Explanation:
Risk-based audits of CRO activities as delegated are considered the most efficient way of overseeing a CRO's management. This approach focuses on evaluating the critical risks that might impact data integrity and participant safety. It allows sponsors to allocate resources to areas with the highest potential for error or deviation, rather than performing exhaustive monitoring of all activities.
The answer is verified as per guidelines on risk-based monitoring strategies, emphasizing targeted and efficient oversight of CRO functions.
"Risk-based monitoring emphasizes focusing on critical study parameters and the risks that have the potential to affect data quality and subject safety." Objectives:
* Efficient management of outsourced clinical trial tasks.
* Ensuring data integrity through targeted audits.
NEW QUESTION # 36
A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?
- A. The site may proceed with the destruction of the essential documents.
- B. The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
- C. The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
- D. The site should retain the essential documents longer to meet the regulatory requirements.
Answer: C
Explanation:
Before destroying any essential documents, the site must obtain written confirmation from the sponsor that these documents are no longer needed. This ensures compliance with regulatory requirements, as some countries may require document retention for longer periods, even after study closure and marketing approval.
GCP guidelines state that the sponsor must confirm in writing that essential documents can be destroyed after ensuring compliance with local regulations.
"Before destroying essential documents, written confirmation from the sponsor is required to ensure compliance with regulatory retention policies." Objectives:
* Maintain compliance with document retention regulations.
* Prevent premature destruction of essential trial records.
NEW QUESTION # 37
Which of the following reports should be retained in participant charts?
- A. IRB/IEC progress reports
- B. Safety reports
- C. DSMB/IDMC reports
- D. Lab reports
Answer: D
Explanation:
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.
NEW QUESTION # 38
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