100% PASS ACRP - ACRP-CP - ACRP CERTIFIED PROFESSIONAL EXAM LATEST LATEST TEST GUIDE

100% Pass ACRP - ACRP-CP - ACRP Certified Professional Exam Latest Latest Test Guide

100% Pass ACRP - ACRP-CP - ACRP Certified Professional Exam Latest Latest Test Guide

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ACRP Certified Professional Exam Sample Questions (Q19-Q24):

NEW QUESTION # 19
The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

  • A. Assure the ads do not impinge on confidentiality agreements.
  • B. Confirm subjects receive the appropriate reimbursement.
  • C. Safeguard the rights, safety, and well-being of all potential subjects.
  • D. Review the content for ethically or morally sensitive issues.

Answer: C

Explanation:
The IRB/IEC's primary responsibility when reviewing recruitment materials such as posters, fliers, social media posts, and promotional items is to ensure that these materials safeguard the rights, safety, and well- being of potential participants. This includes ensuring that the information is presented ethically, clearly, and without coercion, maintaining compliance with ethical guidelines.
GCP guidelines require that any materials used for recruitment be reviewed to ensure they do not mislead participants and that they respect their rights and well-being.
"IRB/IEC review of recruitment materials ensures that they protect participants' rights and well-being and that the content is ethically appropriate." Objectives:
* Maintain ethical standards in recruitment.
* Protect potential participants from misleading or coercive information.


NEW QUESTION # 20
Which of the following elements of the Informed Consent are NOT required?

  • A. Subject legal rights can be waived
  • B. Statement that study involves research
  • C. A description of any reasonably foreseeable risks or discomforts
  • D. A description of potential benefits

Answer: A

Explanation:
Informed consent must not include any language that implies a waiver of the participant's legal rights or releases the investigator, sponsor, or institution from liability for negligence. Such language violates ethical standards and the principles of voluntary participation.
According to GCP guidelines and ethical principles, the informed consent document must not include any clause that waives a participant's legal rights.
"An informed consent form must not include language that waives the participant's legal rights or releases the sponsor or investigator from liability." Objectives:
* Protect participant rights in clinical trials.
* Ensure that consent is given voluntarily and ethically.


NEW QUESTION # 21
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

  • A. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
  • B. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
  • C. A monitoring report that identifies deviation from the approved protocol.
  • D. Training records of site personnel on study protocol, and their study-related duties and functions.

Answer: D

Explanation:
The PI is responsible for maintaining training records of site personnel, which demonstrate compliance with the sponsor's requirements for conducting the trial. Proper documentation of training ensures that all team members are knowledgeable about the protocol and study procedures.
GCP guidelines mandate that the PI maintains adequate records to demonstrate that all personnel involved in the study are properly trained and qualified.
"Training records of site personnel must be maintained to verify that the team is adequately trained on the protocol and their specific responsibilities." Objectives:
* Maintain training compliance.
* Document personnel qualifications for quality assurance.


NEW QUESTION # 22
Which strategy is used to safeguard subject privacy?

  • A. Utilize subject initials on correspondence.
  • B. Email updated enrollment logs to the CRA.
  • C. Store source documentation in the CRC's office.
  • 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 # 23
An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

  • A. PI
  • B. IRB/IEC
  • C. DSMB/IDMC
  • D. Sponsor

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for conducting a root cause analysis when non-compliance is identified at the site. The PI must identify the reasons for non-compliance and develop a Corrective and Preventive Action (CAPA) plan to address and prevent future occurrences.
This answer aligns with GCP principles that designate the PI as responsible for site-level compliance and corrective actions.
"The PI must take responsibility for investigating the cause of non-compliance and developing a CAPA plan to mitigate recurrence." Objectives:
* Maintaining compliance and data integrity
* Addressing non-compliance proactively


NEW QUESTION # 24
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