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ACRP Certified Professional Exam Sample Questions (Q107-Q112):
NEW QUESTION # 107
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
- A. Co-monitoring of CRO site visits
- B. Pre-qualification assessment of CRO
- C. Risk-based audits of CRO activities as delegated
- D. Central monitoring of data fields by sponsor
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 # 108
The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?
- A. A member of the research team
- B. A family member
- C. A witness
- D. A legally acceptable representative
Answer: D
Explanation:
For cognitively impaired participants who may not fully understand the informed consent process, a legally acceptable representative (LAR) must be involved. This ensures that the participant's rights and interests are protected and that consent is obtained ethically and legally.
GCP guidelines mandate that, in cases where participants are unable to provide informed consent, an LAR must be involved to make decisions on their behalf.
"When a participant is cognitively impaired, informed consent must be obtained from a legally acceptable representative to ensure ethical participation." Objectives:
* Safeguard the rights of vulnerable populations.
* Maintain ethical standards in the consent process.
NEW QUESTION # 109
What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?
- A. Routine monitoring
- B. Site qualification
- C. Audit
- D. Inspection
Answer: C
Explanation:
An audit is a systematic and independent examination of trial-related activities and documents. Its purpose is to determine whether the study was conducted in compliance with the protocol, GCP, and regulatory requirements. Audits are usually performed by the sponsor or an independent auditor and focus on evaluating data integrity and trial conduct.
GCP guidelines define an audit as a thorough examination to ensure adherence to protocol and regulatory requirements.
"An audit is a systematic and independent examination of trial-related activities to verify compliance with the protocol and regulatory standards." Objectives:
Ensure compliance and data integrity.
Identify any gaps in trial conduct.
NEW QUESTION # 110
Who on the local site research study team is accountable for the unblinding documentation of IP?
- A. Pharmacist
- B. PI
- C. CRC
- D. Regulatory manager
Answer: B
Explanation:
The Principal Investigator (PI) is ultimately responsible for maintaining and documenting any unblinding events related to the investigational product (IP). This accountability ensures that any instance where the blind is broken is properly justified, documented, and reported to maintain trial integrity.
GCP guidelines state that the PI must oversee the unblinding process and ensure proper documentation to protect the validity of the trial data.
"The PI is responsible for ensuring that any unblinding of the investigational product is adequately documented and reported according to protocol." Objectives:
* Maintain the integrity of blinded studies.
* Properly document unblinding incidents.
NEW QUESTION # 111
Which of the following statements is TRUE about an EDC system?
- A. The eCRF should be an exact page-by-page replica of the paper CRF.
- B. IRB/IEC approval is required before the use of the computerized system.
- C. A separate workstation should be made available for the monitor.
- D. There should be an audit trail to track data entries, deletions, and changes.
Answer: D
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 # 112
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