NEWEST ACRP EXAM ACRP-CP BOOTCAMP OFFER YOU THE BEST FREE VCE DUMPS | ACRP CERTIFIED PROFESSIONAL EXAM

Newest ACRP Exam ACRP-CP Bootcamp Offer You The Best Free Vce Dumps | ACRP Certified Professional Exam

Newest ACRP Exam ACRP-CP Bootcamp Offer You The Best Free Vce Dumps | ACRP Certified Professional Exam

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Tags: Exam ACRP-CP Bootcamp, Free ACRP-CP Vce Dumps, Free ACRP-CP Dumps, ACRP-CP Valid Test Tutorial, ACRP-CP Associate Level Exam

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ACRP Certified Professional Exam Sample Questions (Q76-Q81):

NEW QUESTION # 76
After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

  • A. Submit the diary to the regulatory authority for approval.
  • B. Submit the diary to the sponsor for approval.
  • C. No approval is necessary: give the diary to each subject.
  • D. Submit the diary to the IRB/IEC for approval.

Answer: D

Explanation:
Any new data collection tool introduced during a clinical trial, including subject diaries, must be reviewed and approved by the IRB/IEC before implementation. This ensures that the new tool is ethically appropriate, respects subject privacy, and aligns with the approved protocol.
This answer aligns with ICH E6(R2) GCP guidelines, which mandate IRB/IEC approval for any new or modified subject-related documents introduced during a trial.
"All changes in study documents, including subject diaries, must be submitted for IRB/IEC review to ensure compliance with ethical standards." Objectives:
* Maintain compliance with IRB/IEC requirements.
* Ensure ethical handling of subject data.


NEW QUESTION # 77
While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

  • A. Have the Principal Investigator consent the person.
  • B. There are no circumstances under which this person can be enrolled.
  • C. Locate a translator and have them work with the person.
  • D. Get an impartial witness involved in consenting this person.

Answer: D

Explanation:
When a participant cannot read, an impartial witness must be present during the consent process. The witness ensures that the information is accurately presented and that the subject's consent is truly informed. The witness must sign the consent form to attest that the subject understands the information.
GCP guidelines require the use of an impartial witness during the informed consent process for individuals who are illiterate or visually impaired.
"Informed consent must involve an impartial witness when the subject cannot read, ensuring the consent process is conducted ethically." Objectives:
* Maintain ethical standards during consent.
* Protect the rights of participants with literacy challenges.


NEW QUESTION # 78
AEs that occur between study visits of a clinical trial should be evaluated by the:

  • A. Principal Investigator
  • B. Subject's primary care physician
  • C. Medical monitor
  • D. Study pharmacovigilance physician

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for evaluating Adverse Events (AEs) that occur between study visits. The PI must assess the severity, causality, and potential relationship to the investigational product (IP).
Proper evaluation ensures that any necessary medical interventions are promptly administered and that relevant information is recorded and reported accurately.
GCP guidelines specify that the PI is accountable for the medical care of trial subjects, including evaluating AEs and ensuring their safety.
"The PI must evaluate any adverse events occurring between study visits to determine their relevance to the investigational product and manage patient care." Objectives:
* Ensure prompt and accurate evaluation of AEs.
* Maintain the safety and well-being of study participants.


NEW QUESTION # 79
What would a sponsor use to implement and maintain quality in a study?

  • A. Standard operating procedures
  • B. Protocol signature pages
  • C. Clinical trial agreement
  • D. Statistical analysis plan

Answer: A

Explanation:
Standard Operating Procedures (SOPs) are essential for implementing and maintaining quality in a clinical study. SOPs outline the standardized methods for conducting study-related tasks, ensuring consistency, compliance, and quality across all trial sites. They are critical for training personnel, guiding the conduct of study activities, and maintaining protocol adherence.
GCP guidelines state that sponsors must develop and maintain SOPs to ensure the quality and consistency of clinical trial processes.
"The sponsor should establish SOPs to maintain the quality of clinical trials, covering all aspects of trial conduct, data handling, and safety management." Objectives:
* Ensure consistent and high-quality trial conduct.
* Standardize procedures across trial sites.


NEW QUESTION # 80
Which of the following reports should be retained in participant charts?

  • A. Safety reports
  • B. DSMB/IDMC reports
  • C. Lab reports
  • D. IRB/IEC progress reports

Answer: C

Explanation:
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.


NEW QUESTION # 81
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