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ACRP - ACRP-CP Updated Online Exam

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ACRP Certified Professional Exam Sample Questions (Q13-Q18):

NEW QUESTION # 13
Which strategy is used to safeguard subject privacy?

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

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 # 14
A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A. Investigator's Brochure
B. Standard Operating Procedure
C. Clinical Monitoring Plan
D. Data & Safety Monitoring Plan

Answer: B

Explanation:
The Standard Operating Procedure (SOP) outlines the process for shipping, storing, mixing, and transferring the investigational product (IP) between locations. SOPs ensure that all steps are consistently followed and documented, maintaining the integrity and quality of the IP throughout the handling process. This is critical for maintaining compliance with Good Clinical Practice (GCP) and ensuring patient safety.
GCP guidelines specify that SOPs should cover the handling, transfer, and storage of investigational products to ensure quality control.
"SOPs provide detailed guidance on the handling and transfer of investigational products to ensure consistency and compliance." Objectives:
* Maintain the integrity of IP during transport and handling.
* Ensure compliance through standardized procedures.

NEW QUESTION # 15
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. Quarantine IP without registering in IWRS and request replacement from sponsor.
B. Register IP in IWRS and continue with subject allocation.
C. Register IP in IWRS, quarantine and notify sponsor of the excursion.
D. Dispose of IP and request replacement from sponsor.

Answer: C

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 # 16
After the site qualification visit report has been finalized, it must be:

A. Stored in the sponsor's budgets and contracts file.
B. Kept in the CRO/sponsor's trial master file.
C. Included in the PI's regulatory file.
D. Sent to the IRB/IEC for review and approval.

Answer: B

Explanation:
The finalized site qualification visit report must be maintained in the sponsor's trial master file (TMF) as part of the essential documents. The TMF serves as the repository for all documents that demonstrate compliance with the protocol and regulatory requirements. Storing the report in the TMF ensures traceability and documentation of the site's suitability for conducting the trial.
GCP guidelines require that site qualification visit reports be included in the trial master file to maintain comprehensive documentation of site assessments.
"Finalized site qualification visit reports must be stored in the sponsor's trial master file to ensure proper documentation and compliance." Objectives:
* Maintain documentation of site qualifications.
* Ensure compliance through comprehensive record-keeping.

NEW QUESTION # 17
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A. IB, site coordinator CVs, and information about payments and compensation available to subjects
B. Protocol, informed consent, and clinical trial agreement
C. Protocol, IB, and information about payments and compensation available to subjects
D. Protocol, site coordinator CVs, and clinical trial agreement

Answer: C

Explanation:
Before a clinical trial can begin, the IRB/IEC must review the protocol, Investigator's Brochure (IB), and any information related to payments and compensation. This review ensures that the study is ethically sound, scientifically valid, and that participants are informed about any financial considerations.
GCP guidelines specify that essential documents, including the protocol, IB, and compensation details, must be reviewed by the IRB/IEC to maintain ethical oversight.
"The IRB/IEC must evaluate the protocol, IB, and any financial disclosures to ensure ethical compliance and participant protection." Objectives:
* Guarantee ethical oversight in clinical trial conduct.
* Protect participants through informed consent and transparency.

NEW QUESTION # 18
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