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ACRP Certified Professional Exam Sample Questions (Q125-Q130):
NEW QUESTION # 125
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
- A. Pre-qualification assessment of CRO
- B. Central monitoring of data fields by sponsor
- C. Co-monitoring of CRO site visits
- D. Risk-based audits of CRO activities as delegated
Answer: D
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 # 126
At a close-out visit, which document should be retained only at the site?
- A. IP accountability
- B. Final trial close-out monitoring report
- C. Treatment allocation
- D. Subject identification code list
Answer: D
Explanation:
The subject identification code list, which links the participant's unique code to their personal information, must be retained only at the site. This list ensures confidentiality and is necessary for identifying participants during follow-up. It is not shared with the sponsor to protect participant privacy.
GCP guidelines mandate that the subject identification code list remains at the site to ensure confidentiality and compliance with data protection regulations.
"The subject identification code list must be securely stored at the site to maintain participant confidentiality." Objectives:
* Safeguard participant confidentiality.
* Maintain compliance with data protection policies.
NEW QUESTION # 127
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?
- A. CRC
- B. PI
- C. Sponsor
- D. Regulatory Agency
Answer: B
Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.
NEW QUESTION # 128
Which one of the following is a primary objective of a Phase III study of a new IP?
- A. To demonstrate or confirm therapeutic benefit
- B. To show superiority over another treatment
- C. To establish the safety profile
- D. To establish dose information
Answer: A
Explanation:
Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.
According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.
"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments." Objectives:
* Confirm therapeutic efficacy.
* Provide comprehensive safety data.
NEW QUESTION # 129
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?
- A. The frequency of data backup was not defined.
- B. The number of unique eCRF templates was not specified.
- C. The number of users with access was not defined.
- D. The list of comparable technology solutions was not included.
Answer: A
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 # 130
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