ACRP-CP TEST KING & TRUSTWORTHY ACRP-CP PDF

ACRP-CP Test King & Trustworthy ACRP-CP Pdf

ACRP-CP Test King & Trustworthy ACRP-CP Pdf

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ACRP Certified Professional Exam Sample Questions (Q108-Q113):

NEW QUESTION # 108
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. Report a protocol deviation to the IRB/IEC.
  • B. Notify the PI.
  • C. Notify the sponsor.
  • D. Call the participant to return for an unscheduled visit.

Answer: B

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 # 109
Which of the following reports should be retained in participant charts?

  • A. IRB/IEC progress reports
  • B. Lab reports
  • C. Safety reports
  • D. DSMB/IDMC reports

Answer: B

Explanation:
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.


NEW QUESTION # 110
Centralized monitoring can:

  • A. Confirm why sites are deviating from the protocol.
  • B. Indicate the need to send monitors to perform onsite visits.
  • C. Enable appropriate stratification of subject enrollment.
  • D. Identify IP accountability and storage issues.

Answer: B

Explanation:
Centralized monitoring involves the remote evaluation of data trends, outliers, and inconsistencies across sites. If significant issues are identified through centralized monitoring, it may prompt the need for targeted on-site visits to investigate and resolve the identified issues. This approach optimizes resource utilization and focuses on potential problem areas.
GCP guidelines support the use of centralized monitoring to identify risks that warrant on-site monitoring, promoting efficient and targeted oversight.
"Centralized monitoring can identify data patterns or anomalies that indicate the need for an on-site visit to verify and address the issue." Objectives:
* Enhance monitoring efficiency through data-driven decisions.
* Prioritize on-site visits based on identified risks.


NEW QUESTION # 111
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

  • A. Investigator
  • B. CRC
  • C. Sponsor
  • D. CRO

Answer: C

Explanation:
The sponsor is responsible for ensuring that agreements are in place with all involved parties (including investigators and institutions) to grant direct access to trial-related source documents. This is crucial for monitoring, auditing, and inspection purposes, ensuring transparency and compliance with regulatory requirements.
According to GCP guidelines, the sponsor must establish agreements to secure direct access to trial data for verification and compliance checks.
"The sponsor should ensure that agreements are in place to permit direct access to source data and documents for monitoring and inspection." Objectives:
* Maintain compliance with regulatory requirements.
* Facilitate data verification and quality assurance.


NEW QUESTION # 112
Which strategy is used to safeguard subject privacy?

  • A. Email updated enrollment logs to the CRA.
  • B. Store source documentation in the CRC's office.
  • C. Conduct subject-related conversations in controlled environments.
  • D. Utilize subject initials on correspondence.

Answer: C

Explanation:
Conducting subject-related conversations in controlled environments ensures that personal and sensitive information is not overheard or disclosed to unauthorized individuals. This practice upholds patient confidentiality as required by GCP and data protection regulations.
The answer follows GCP guidelines for protecting the privacy and confidentiality of clinical trial participants.
"Conversations regarding study subjects should be held in secure and controlled environments to protect personal data." Objectives:
* Ensuring confidentiality in clinical trial settings.
* Protecting patient privacy according to ethical standards.


NEW QUESTION # 113
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