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ACRP Certified Professional Exam Sample Questions (Q84-Q89):

NEW QUESTION # 84
When assessing the monitoring needs for a study, sponsors should:

A. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
B. Use central monitoring instead of conducting physical monitoring visits at sites.
C. Permit PIs to select a monitor for their site as long as they are independent of the PI.
D. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.

Answer: D

Explanation:
Sponsors must ensure that monitors are adequately qualified, possessing the necessary scientific and clinical knowledge to effectively oversee the trial. This ensures that monitors can accurately assess protocol compliance, data integrity, and participant safety. The quality of monitoring directly impacts the credibility of the trial outcomes.
GCP guidelines specify that monitors must be adequately trained and knowledgeable about the trial protocol, investigational product (IP), and clinical research standards.
"The sponsor must ensure that monitors have appropriate qualifications and training to conduct effective trial monitoring." Objectives:
* Maintain data integrity through skilled monitoring.
* Ensure patient safety and protocol compliance.

NEW QUESTION # 85
A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A. 5 participants
B. 6 participants
C. 4 participants
D. 3 participants

Answer: D

Explanation:
Since the protocol specifies that participants withdrawn due to an Adverse Event (AE) should not bereplaced, only the participants withdrawn for noncompliance (3 in total) should be replaced. The participant who withdrew consent due to severe nausea (an AE) and the one who discontinued IP due to hospitalization should not be replaced.
GCP guidelines specify that replacement of subjects should follow the protocol criteria, particularly when AEs are involved.
"Participants withdrawn due to AEs should not be replaced if the protocol stipulates this condition, while noncompliant participants may be replaced." Objectives:
* Follow protocol guidelines for participant replacement.
* Ensure compliance with study criteria.

NEW QUESTION # 86
The coding system for a double-blind clinical trial is accessible by the:

A. PI
B. IRB/IEC
C. Sponsor
D. Regulatory authority

Answer: C

Explanation:
The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.
GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.
"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study's integrity." Objectives:
* Maintain the integrity of double-blind trials.
* Allow controlled access to randomization codes.

NEW QUESTION # 87
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. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D. Training records of site personnel on study protocol, and their study-related duties and functions.

Answer: D

Explanation:
The PI is responsible for maintaining training records of site personnel, which demonstrate compliance with the sponsor's requirements for conducting the trial. Proper documentation of training ensures that all team members are knowledgeable about the protocol and study procedures.
GCP guidelines mandate that the PI maintains adequate records to demonstrate that all personnel involved in the study are properly trained and qualified.
"Training records of site personnel must be maintained to verify that the team is adequately trained on the protocol and their specific responsibilities." Objectives:
* Maintain training compliance.
* Document personnel qualifications for quality assurance.

NEW QUESTION # 88
The inclusion and exclusion criteria are in place so all subjects are:

A. Healthy and willing to complete the clinical trial.
B. Patients with the disease under study and will not have any adverse events.
C. Medically appropriate and protected from ethical vulnerability.
D. Ethically vulnerable and patients with the disease under study.

Answer: C

Explanation:
Inclusion and exclusion criteria are designed to ensure that participants are medically appropriate for the study and are not ethically vulnerable. This reduces risks to subjects and ensures that the collected data accurately reflects the target population.
The answer follows GCP principles that emphasize participant safety and data validity through well-defined inclusion/exclusion criteria.
"Inclusion and exclusion criteria are crucial for ensuring the safety of participants and the scientific validity of study results." Objectives:
* Ensuring participant safety.
* Maintaining ethical standards in clinical research.

NEW QUESTION # 89
......

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