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Visual ACRP-CP Cert Test - Dumps ACRP-CP Guide

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ACRP Certified Professional Exam Sample Questions (Q105-Q110):

NEW QUESTION # 105
All of the following are examples of what monitors review EXCEPT:

A. The signed ICF retained in the participant's study file.
B. Potential patient medical records for eligibility prior to the informed consent process.
C. Documentation in the participant's medical record of study drug administration.
D. Regulatory binder which includes copies of current certifications for all laboratories.

Answer: B

Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration.
However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations." Objectives:
* Understand the scope of monitoring responsibilities.
* Protect patient confidentiality during the monitoring process.

NEW QUESTION # 106
Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A. Register IP in IWRS, quarantine and notify sponsor of the excursion.
B. Register IP in IWRS and continue with subject allocation.
C. Quarantine IP without registering in IWRS and request replacement from sponsor.
D. Dispose of IP and request replacement from sponsor.

Answer: A

Explanation:
If a temperature-controlled IP has experienced a temperature excursion during transport, the appropriate action is to register the IP in the Interactive Web Response System (IWRS), quarantine it to prevent use, and immediately notify the sponsor. This procedure ensures that the IP is not used until the sponsor evaluates its stability and suitability.
GCP guidelines state that any IP affected by a temperature excursion should be quarantined and reported to the sponsor for evaluation.
"Upon identification of a temperature excursion, the IP must be quarantined and reported to the sponsor to determine its usability." Objectives:
* Maintain IP integrity and compliance with storage conditions.
* Follow protocol for managing temperature excursions.

NEW QUESTION # 107
Source data/documentation should be:

A. Attributable, legible, correct, original, accurate, and complete.
B. Attributable, legible, correct, original, accurate, and clear.
C. Attributable, legible, contemporaneous, original, accurate, and complete.
D. Attributable, legible, contemporaneous, original, accurate, and clear.

Answer: C

Explanation:
Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high- quality, reliable, and verifiable clinical trial records.
GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.
"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards." Objectives:
* Maintain data integrity and reliability.
* Adhere to best practices in clinical documentation.

NEW QUESTION # 108
Who ensures information regarding payments to subjects is documented in a written consent form?

A. IRB/IEC
B. PI
C. Coordinator
D. Sponsor

Answer: A

Explanation:
The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.
The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.
"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants." Objectives:
* Guaranteeing informed consent quality
* Ensuring transparency about participant payments

NEW QUESTION # 109
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. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
B. Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
C. Report this incident immediately to the sponsor and leave the treatment decision to them.
D. Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.

Answer: B

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 # 110
......

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