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ACRP-CP Formal Test - Latest ACRP-CP Braindumps

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ACRP Certified Professional Exam Sample Questions (Q68-Q73):

NEW QUESTION # 68
Which of the following elements of the Informed Consent are NOT required?

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

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 # 69
Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A. Train the research coordinator on the required study assessments schedule.
B. Determine the quality tolerance limits for data transcription errors.
C. Perform a periodic review to see if the quality methods are effective and relevant.
D. Identify critical processes and data during protocol development.

Answer: D

Explanation:
The first step in establishing a robust quality management system (QMS) is to identify critical processes and data during protocol development. This step ensures that quality objectives are clear and that monitoring and quality control efforts are focused on the most significant aspects of the study. By understanding critical data points and processes early, the sponsor can design a more effective QMS to manage risks.
GCP guidelines emphasize identifying critical data and processes at the earliest stages to develop a risk-based quality management approach.
"Identification of critical data and processes at the protocol development stage is essential for designing an effective quality management system." Objectives:
* Establish quality oversight from the start.
* Implement a risk-based monitoring approach.

NEW QUESTION # 70
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A. Length of time to receive the approved trial device
B. Location of stored trial records
C. Information to be included in the advertising flyer
D. Availability of qualified staff to conduct the trial

Answer: D

Explanation:
The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial's integrity and data quality are compromised.
This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.
"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements." Objectives:
* Assessing resource availability
* Ensuring readiness to initiate a clinical trial

NEW QUESTION # 71
Who is responsible for the ongoing safety evaluation of the IP?

A. IRB/IEC
B. Sponsor
C. PI
D. Regulatory agency

Answer: B

Explanation:
The sponsor is primarily responsible for the ongoing safety evaluation of the investigational product (IP) throughout the clinical trial. This responsibility includes monitoring adverse events, reporting serious adverse events (SAEs) to regulatory authorities, and updating the Investigator's Brochure (IB) with relevant safety data.
According to GCP guidelines, the sponsor must continuously evaluate safety data and report findings to regulatory bodies as necessary.
"The sponsor is responsible for the continuous safety monitoring of the investigational product and for ensuring that new safety information is communicated to investigators and regulators." Objectives:
* Ensure participant safety throughout the study.
* Maintain accurate and timely reporting of safety data.

NEW QUESTION # 72
Who must be blinded in a double-blind study in order to prevent bias?

A. IRB/IEC
B. Pharmacist
C. Subject
D. Data entry staff

Answer: C

Explanation:
In a double-blind study, both the participant (subject) and the investigator (or clinical staff administering the treatment) are blinded. This approach minimizes bias in treatment administration and outcome assessment.
Blinding the subject ensures that their responses are not influenced by their knowledge of the treatment they are receiving.
According to GCP guidelines, double-blinding is essential to eliminate both participant and investigator bias, ensuring objective trial results.
"Double-blind studies ensure that neither the participant nor the investigator knows which intervention is being administered, thereby minimizing bias." Objectives:
* Maintain the integrity of the study by preventing bias.
* Enhance the validity of trial outcomes.

NEW QUESTION # 73
......

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