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ACRP Certified Professional Exam Sample Questions (Q105-Q110):
NEW QUESTION # 105
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?
- A. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
- B. A monitoring report that identifies deviation from the approved protocol.
- C. Training records of site personnel on study protocol, and their study-related duties and functions.
- D. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
Answer: C
NEW QUESTION # 106
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:
- A. Sponsor
- B. CRC
- C. CRA
- D. PI
Answer: D
Explanation:
The Principal Investigator (PI) is responsible for providing access to study documentation during an audit or inspection. This includes regulatory files, participant records, and study logs. The PI ensures that auditors and inspectors have appropriate access while maintaining the confidentiality of subject data.
GCP guidelines clearly assign the responsibility for maintaining and granting access to trial documentation to the PI at the study site.
"The PI is responsible for ensuring that study-related documents are available for review during audits or inspections." Objectives:
* Maintain transparency during inspections.
* Ensure compliance with documentation requirements.
NEW QUESTION # 107
The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?
- A. Schedule participant for early termination visit.
- B. Inform the IRB/IEC of the study closure.
- C. Inform the monitor of the termination of the study.
- D. Inform participant and assure proper care is provided.
Answer: D
Explanation:
When a study is temporarily suspended, the primary responsibility of the research team is to ensure the ongoing care and safety of the enrolled participants. Participants must be informed about the suspension and assured that their health and safety will continue to be monitored.
GCP guidelines prioritize the safety and well-being of participants, which must be maintained even during a temporary suspension.
"In the event of a study suspension, the first priority is to inform the participants and ensure that appropriate care and monitoring are continued." Objectives:
* Protect participant safety during study suspension.
* Maintain clear communication with study participants.
NEW QUESTION # 108
All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:
- A. Identifying potential study risks.
- B. Documenting all possible risk scenarios.
- C. Assessing risk based on study impact.
- D. Controlling risk by setting thresholds of risk acceptability.
Answer: B
Explanation:
While identifying potential risks, assessing them based on their impact, and setting risk acceptability thresholds are integral parts of a risk management approach, documenting every possible risk scenario is impractical and unnecessary. Instead, focus should be on identifying and managing the most significant and likely risks that could affect the study's quality and safety.
GCP guidelines emphasize identifying, assessing, and controlling critical risks rather than exhaustively documenting all hypothetical scenarios.
"Effective risk management involves identifying key risks, evaluating their impact, and setting control measures, rather than documenting every possible risk." Objectives:
* Implement practical and targeted risk management strategies.
* Focus on significant and likely risks rather than hypothetical ones.
NEW QUESTION # 109
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
- A. Placebo-controlled
- B. Randomization
- C. Privacy controls
- D. Blinding
Answer: B
Explanation:
Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.
GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.
"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups." Objectives:
* Maintain scientific rigor through randomization.
* Minimize selection bias in clinical studies.
NEW QUESTION # 110
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