100% PASS 2025 ACRP HIGH PASS-RATE ACRP-CP COST EFFECTIVE DUMPS

100% Pass 2025 ACRP High Pass-Rate ACRP-CP Cost Effective Dumps

100% Pass 2025 ACRP High Pass-Rate ACRP-CP Cost Effective Dumps

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Tags: ACRP-CP Cost Effective Dumps, ACRP-CP Exam Answers, ACRP-CP Valid Vce, ACRP-CP Standard Answers, ACRP-CP Valid Exam Preparation

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ACRP Certified Professional Exam Sample Questions (Q62-Q67):

NEW QUESTION # 62
An impartial witness should be present during the entire informed consent discussion when:

  • A. A parent/guardian is consenting for a minor subject.
  • B. A legally acceptable representative is unable to read.
  • C. An interpreter is translating the consent form for a subject.
  • D. A subject has been determined to be vulnerable.

Answer: B

Explanation:
An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.
GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.
"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound." Objectives:
* Protect the rights of individuals with literacy challenges.
* Maintain ethical standards in the consent process.


NEW QUESTION # 63
Who is responsible for submitting a protocol amendment to the IRB/IEC?

  • A. CRC
  • B. Sponsor
  • C. Investigator
  • D. CRA

Answer: C

Explanation:
The investigator holds the responsibility for submitting any protocol amendments to the IRB/IEC for review and approval. This step ensures that all changes are ethically evaluated before being implemented, maintaining compliance with regulatory requirements.
According to GCP guidelines, the investigator must submit protocol changes to the IRB/IEC to secure approval before making any modifications to the study.
"The investigator must inform the IRB/IEC of any proposed protocol changes and secure approval prior to implementation." Objectives:
* Maintain ethical oversight in study modifications.
* Adhere to regulatory submission requirements.


NEW QUESTION # 64
All of the following are examples of what monitors review EXCEPT:

  • A. Documentation in the participant's medical record of study drug administration.
  • B. Regulatory binder which includes copies of current certifications for all laboratories.
  • C. Potential patient medical records for eligibility prior to the informed consent process.
  • D. The signed ICF retained in the participant's study file.

Answer: C

Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration.
However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations." Objectives:
* Understand the scope of monitoring responsibilities.
* Protect patient confidentiality during the monitoring process.


NEW QUESTION # 65
A study protocol must contain which of the following elements?

  • A. Data management plan
  • B. Description of statistical methods
  • C. Participant reimbursement details
  • D. Chemical structure of the IP

Answer: B

Explanation:
A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.
GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.
"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results." Objectives:
* Maintain transparency in data analysis.
* Ensure scientific rigor in evaluating study outcomes.


NEW QUESTION # 66
A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

  • A. This qualifies for prompt reporting to the IRB/IEC within 15 business days.
  • B. This needs to be reported to the patient's primary care physician.
  • C. This qualifies for expedited reporting to the sponsor.
  • D. This needs to be reported to the regulatory authorities within 10 business days.

Answer: C

Explanation:
Any serious adverse event (SAE) that is unexpected, especially those involving congenital anomalies or birth defects, must be reported to the sponsor as an expedited safety report. The reporting should occur immediately to ensure prompt assessment and necessary action.
The answer aligns with ICH E6(R2) GCP guidelines, which require immediate reporting of SAEs related to IP use.
"Expedited reporting to the sponsor is required for unexpected serious adverse drug reactions, particularly those involving congenital anomalies." Objectives:
* Immediate safety reporting.
* Protecting the health of trial participants and their offspring.


NEW QUESTION # 67
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