ACRP ACRP-CP TEST CENTRES, ACRP-CP TEST QUESTIONS VCE

ACRP ACRP-CP Test Centres, ACRP-CP Test Questions Vce

ACRP ACRP-CP Test Centres, ACRP-CP Test Questions Vce

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Tags: ACRP-CP Test Centres, ACRP-CP Test Questions Vce, Testking ACRP-CP Exam Questions, ACRP-CP Valid Exam Question, ACRP-CP Review Guide

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ACRP-CP Exam Questions - ACRP Certified Professional Exam Exam Tests & ACRP-CP Test Guide

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ACRP Certified Professional Exam Sample Questions (Q103-Q108):

NEW QUESTION # 103
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. Locate a translator and have them work with the person.
  • C. There are no circumstances under which this person can be enrolled.
  • 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 # 104
The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

  • A. Use of concomitant medications to treat the symptoms
  • B. Impact of an approved vaccine against the disease
  • C. Occurrence of known side effects of the IP
  • D. Time to occurrence of symptoms of the disease

Answer: D

Explanation:
In a clinical trial aimed at assessing whether an IP prevents disease recurrence, the primary endpoint would typically be the "time to occurrence of symptoms" indicating a relapse or recurrence. This endpoint directly measures the IP's effectiveness in prolonging the symptom-free period.
This answer follows the GCP guideline, which states that primary endpoints should directly reflect the trial's objectives, particularly when evaluating recurrence prevention.
"In trials evaluating recurrence prevention, the primary endpoint should measure the time until recurrence of the target symptoms or condition." Objectives:
* Assess the efficacy of IP in preventing disease recurrence.
* Accurately measure the time to recurrence as a primary endpoint.


NEW QUESTION # 105
What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

  • A. Audit
  • B. Inspection
  • C. Site qualification
  • D. Routine monitoring

Answer: A

Explanation:
An audit is a systematic and independent examination of trial-related activities and documents. Its purpose is to determine whether the study was conducted in compliance with the protocol, GCP, and regulatory requirements. Audits are usually performed by the sponsor or an independent auditor and focus on evaluating data integrity and trial conduct.
GCP guidelines define an audit as a thorough examination to ensure adherence to protocol and regulatory requirements.
"An audit is a systematic and independent examination of trial-related activities to verify compliance with the protocol and regulatory standards." Objectives:
Ensure compliance and data integrity.
Identify any gaps in trial conduct.


NEW QUESTION # 106
Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

  • A. 3.6 mg/dL
  • B. 2.6 mg/dL
  • C. 3.0 mg/dL
  • D. 1.8 mg/dL

Answer: C

Explanation:
To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.
1.2 x 2.5 = 3.0 mg/dL
Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg
/dL.
GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.
"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity." Objectives:
* Maintain accurate interpretation of laboratory criteria.
* Ensure compliance with protocol-defined inclusion/exclusion criteria.


NEW QUESTION # 107
Who is responsible for the ongoing safety evaluation of the IP?

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

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 # 108
......

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