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Sample ACRP-CP Questions Pdf - ACRP-CP Valid Vce

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Sample ACRP-CP Questions Pdf - ACRP-CP Valid Vce

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ACRP Certified Professional Exam Sample Questions (Q47-Q52):NEW QUESTION # 47
When assessing the monitoring needs for a study, sponsors should:
  • A. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
  • B. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
  • C. Permit PIs to select a monitor for their site as long as they are independent of the PI.
  • D. Use central monitoring instead of conducting physical monitoring visits at sites.
Answer: B
Explanation:
Sponsors must ensure that monitors are adequately qualified, possessing the necessary scientific and clinical knowledge to effectively oversee the trial. This ensures that monitors can accurately assess protocol compliance, data integrity, and participant safety. The quality of monitoring directly impacts the credibility of the trial outcomes.
GCP guidelines specify that monitors must be adequately trained and knowledgeable about the trial protocol, investigational product (IP), and clinical research standards.
"The sponsor must ensure that monitors have appropriate qualifications and training to conduct effective trial monitoring." Objectives:
* Maintain data integrity through skilled monitoring.
* Ensure patient safety and protocol compliance.

NEW QUESTION # 48
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
  • A. Randomization
  • B. Privacy controls
  • C. Blinding
  • D. Placebo-controlled
Answer: A
Explanation:
Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.
GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.
"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups." Objectives:
* Maintain scientific rigor through randomization.
* Minimize selection bias in clinical studies.

NEW QUESTION # 49
The PI should ensure that source data is:
  • A. On worksheets that are provided by the sponsor.
  • B. Accurately reflected in the eCRFs.
  • C. Printed directly from the EMR.
  • D. Kept on site for a minimum of 2 years.
Answer: B
Explanation:
The PI is responsible for ensuring that the source data is accurately recorded in the electronic Case Report Forms (eCRFs). This accurate transposition of data is critical to maintaining data integrity and ensuring that the data collected at the site is consistent with the reported clinical outcomes.
GCP guidelines specify that source data should be accurate, legible, and directly reflected in the CRFs to maintain consistency and reliability.
"The PI must ensure that the source data are accurately and completely recorded in the eCRFs to maintain data integrity." Objectives:
* Ensure accurate data transposition from source to CRF.
* Maintain high standards of data quality and reliability.

NEW QUESTION # 50
In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
  • A. CRC
  • B. Sponsor
  • C. CRA
  • D. Investigator
Answer: D
Explanation:
The Principal Investigator (PI) holds ultimate responsibility for ensuring that all study-related functions are conducted by qualified and trained personnel. The PI must verify that staff have the necessary qualifications and training to perform their assigned tasks as outlined in the protocol. This responsibility is crucial for maintaining compliance with GCP and ensuring data integrity.
According to GCP guidelines, the PI must ensure that all staff assisting with the trial are adequately trained and qualified for their roles.
"The investigator is responsible for ensuring that all persons assisting with the trial are qualified by education, training, and experience to perform their respective tasks." Objectives:
* Maintain compliance with GCP requirements.
* Ensure qualified personnel conduct study tasks.

NEW QUESTION # 51
A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?
  • A. Rely on the sponsor to notify the IRB/IEC.
  • B. Decline the study.
  • C. Use a central IRB/IEC.
  • D. Recruit for the study without use of social media.
Answer: B
Explanation:
If the IRB/IEC has a policy that does not permit social media recruiting, the site must adhere to these regulations. Proceeding with a method not approved by the IRB/IEC would violate compliance requirements, so declining the study is the correct course of action.
The answer aligns with IRB/IEC regulations that prioritize ethical and compliant recruitment methods.
"Sites must follow the recruitment methods approved by their IRB/IEC to maintain compliance and ethical standards." Objectives:
* Adhering to ethical recruitment practices.
* Maintaining compliance with IRB/IEC policies.

NEW QUESTION # 52
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