TEST ACRP-CP DURATION | ACRP-CP VALID EXAM SIMULATOR

Test ACRP-CP Duration | ACRP-CP Valid Exam Simulator

Test ACRP-CP Duration | ACRP-CP Valid Exam Simulator

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Tags: Test ACRP-CP Duration, ACRP-CP Valid Exam Simulator, ACRP-CP Reliable Exam Braindumps, ACRP-CP Reliable Test Forum, ACRP-CP Exams Training

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ACRP Certified Professional Exam Sample Questions (Q48-Q53):

NEW QUESTION # 48
The sponsor should supply a PI with the IP after:

  • A. Submission of documents to IRB/IEC and regulatory authority for review.
  • B. Approval/favorable opinion from IRB/IEC and regulatory authority.
  • C. Approval of protocol by the PI.
  • D. Approval of protocol by the sponsor.

Answer: B

Explanation:
The sponsor may only provide the investigational product (IP) after the IRB/IEC and relevant regulatory authorities have approved the protocol. This ensures that the trial complies with ethical and legal standards before initiating IP administration.
According to GCP guidelines, sponsors must wait for all necessary approvals before distributing IP to the trial site.
"The investigational product may only be supplied after obtaining regulatory and IRB/IEC approval to ensure ethical conduct of the trial." Objectives:
* Ensure regulatory compliance before initiating IP distribution.
* Protect participant safety and ethical standards.


NEW QUESTION # 49
During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

  • A. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
  • B. Immediately unblind the entire trial to ensure patient safety.
  • C. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
  • D. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.

Answer: A

Explanation:
In this situation, the correct course of action is to request the DSMB to conduct a thorough risk assessment and provide recommendations on unblinding the affected sub-group.
* Reasoning:
* The trial protocol specifies that unblinding should only occur if a life-threatening situation arises.
Since the observed hepatotoxicity, although severe, does not automatically qualify as life- threatening, it is prudent to proceed cautiously.
* Immediate unblinding of the entire trial (Option A) would compromise the study's integrity and could introduce bias.
* Submitting the DSMB findings to the IRB/IEC (Option B) without first conducting a more thorough risk assessment may delay necessary safety measures.
* Conducting a protocol amendment (Option C) without a comprehensive risk assessment may be premature.
* Role of the DSMB:
* The DSMB is responsible for evaluating safety data and making independent recommendations to protect trial participants. In this case, the DSMB should analyze the risk/benefit ratio of continuing the trial with the current protocol versus implementing safety modifications.
* Ethical Considerations:
* Protecting patient safety is paramount, but any unblinding must be justified by a clear and imminent risk. The DSMB's independent judgment is critical to making this decision without sponsor influence.
Verified Answer from Official Source:
According to GCP guidelines, any decision to unblind a study must be based on a comprehensive safety assessment, and the DSMB plays a key role in making unbiased recommendations regarding unblinding.
Exact Extract:
"Unblinding in a clinical trial should only occur when justified by critical safety concerns, as recommended by an independent data monitoring committee." Objectives:
* Maintain trial integrity while safeguarding patient safety.
* Follow protocol and regulatory requirements for unblinding.
* Ensure independent decision-making by the DSMB to avoid sponsor bias.


NEW QUESTION # 50
Which strategy is used to safeguard subject privacy?

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

Answer: D

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 # 51
Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

  • A. CRA
  • B. CRO
  • C. Data Manager
  • D. Sponsor

Answer: D

Explanation:
The sponsor is responsible for establishing written procedures to ensure that all changes or corrections in Case Report Forms (CRFs) are properly documented and justified. These procedures must include who is authorized to make changes, how corrections are documented, and how they are endorsed by the investigator.
This practice ensures data accuracy and traceability.
GCP guidelines indicate that sponsors must establish and maintain procedures for data handling and documentation to ensure accuracy and reliability.
"The sponsor should develop written procedures to ensure that CRF changes are justified, documented, and endorsed by the investigator." Objectives:
* Maintain data accuracy and consistency.
* Ensure transparent documentation practices.


NEW QUESTION # 52
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

  • A. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
  • B. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
  • C. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
  • D. Update the IB to add the risk of infection and submit to the sponsor for approval.

Answer: A

Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection." Objectives:
Ensure prompt reporting of safety concerns.
Maintain compliance with ethical oversight requirements.


NEW QUESTION # 53
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