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ACRP Certified Professional Exam Sample Questions (Q109-Q114):

NEW QUESTION # 109
Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A. Call the participant to return for an unscheduled visit.
B. Notify the sponsor.
C. Report a protocol deviation to the IRB/IEC.
D. Notify the PI.

Answer: D

Explanation:
The CRC's first responsibility is to immediately inform the Principal Investigator (PI), who is responsible for the participant's medical care. The PI will assess the situation, determine the potential risk, and initiate appropriate clinical actions to ensure the participant's safety. This may include medical evaluation or adjusting the dosing regimen.
According to GCP guidelines, any issue that may affect participant safety should be promptly communicated to the PI to ensure appropriate medical management.
"The investigator must be informed immediately of any events that could compromise participant safety, allowing for prompt clinical decision-making." Objectives:
* Ensure rapid response to dosing errors.
* Maintain participant safety as a priority.

NEW QUESTION # 110
Who is responsible for submitting a protocol amendment to the IRB/IEC?

A. CRC
B. Investigator
C. Sponsor
D. CRA

Answer: B

Explanation:
The investigator holds the responsibility for submitting any protocol amendments to the IRB/IEC for review and approval. This step ensures that all changes are ethically evaluated before being implemented, maintaining compliance with regulatory requirements.
According to GCP guidelines, the investigator must submit protocol changes to the IRB/IEC to secure approval before making any modifications to the study.
"The investigator must inform the IRB/IEC of any proposed protocol changes and secure approval prior to implementation." Objectives:
* Maintain ethical oversight in study modifications.
* Adhere to regulatory submission requirements.

NEW QUESTION # 111
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A. Sponsor
B. CRO
C. PI
D. Subject

Answer: A

Explanation:
The sponsor is responsible for defining the criteria and procedures for subject withdrawal or discontinuation of consent. This includes specifying how data already collected will be handled and whether any follow-up is required. The procedures must be clearly outlined in the study protocol and communicated to the research team.
This answer follows GCP guidelines, which state that the sponsor must ensure that procedures for subject withdrawal are clearly defined and documented.
"The sponsor is responsible for defining procedures to be followed if a subject discontinues participation or withdraws consent, including handling of data collected prior to withdrawal." Objectives:
* Ensure transparent procedures for participant withdrawal.
* Maintain data integrity while respecting participant autonomy.

NEW QUESTION # 112
A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A. Report this incident immediately to the sponsor and leave the treatment decision to them.
B. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
C. Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
D. Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.

Answer: D

Explanation:
The investigator must prioritize the subject's immediate health and safety. In a medical emergency, the appropriate response is to advise the ER doctor to proceed with the necessary medical intervention (blood transfusion). Afterward, the PI must promptly report the incident to the sponsor as a protocol deviation.
GCP guidelines emphasize that patient safety takes precedence over protocol requirements in emergency situations.
"In situations where immediate medical intervention is necessary to prevent harm, the investigator should ensure that the appropriate care is given and subsequently report the event as a deviation." Objectives:
* Prioritize patient safety in emergencies.
* Report protocol deviations promptly.

NEW QUESTION # 113
The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

A. Quality Control
B. Programming
C. Validation
D. Quality Assurance

Answer: C

Explanation:
Validation is the process of ensuring that an electronic data processing system meets the sponsor's specifications for completeness, accuracy, reliability, and consistent performance. It involves systematic testing and documentation to demonstrate that the system functions as intended, especially in the context of capturing, processing, and managing clinical trial data.
GCP guidelines specify that validation of electronic systems is crucial to maintain data integrity and compliance with regulatory standards.
"Validation ensures that electronic data systems function according to the sponsor's requirements, maintaining data accuracy and reliability." Objectives:
Maintain data integrity and reliability.
Demonstrate system compliance with regulatory requirements.

NEW QUESTION # 114
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ACRP-CP Valid Braindumps Sheet | ACRP-CP Reliable Braindumps

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ACRP Certified Professional Exam Sample Questions (Q109-Q114):

ACRP-CP Valid Braindumps Sheet Makes Passing ACRP Certified Professional Exam More Convenient