RELIABLE ACRP ACRP-CP TEST TUTORIAL | RELIABLE ACRP-CP EXAM TOPICS

Reliable ACRP ACRP-CP Test Tutorial | Reliable ACRP-CP Exam Topics

Reliable ACRP ACRP-CP Test Tutorial | Reliable ACRP-CP Exam Topics

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ACRP Certified Professional Exam Sample Questions (Q100-Q105):

NEW QUESTION # 100
A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

  • A. Accept this site and implement and maintain QA and QC systems with written SOPs.
  • B. Before accepting this site, report the risk to the trial sponsor and await their decision.
  • C. Accept this site and plan to undertake routine safety evaluations of the IP.
  • D. Before accepting this site, ensure the refrigerator is calibrated and functioning properly.

Answer: B

Explanation:
Since the Wi-Fi connectivity is inconsistent, the CRA must assess the risk and report it to the trial sponsor for a decision. Accepting the site without proper risk evaluation may compromise the monitoring of the investigational product (IP) storage conditions, affecting trial integrity.
The answer follows GCP guidelines that emphasize assessing potential risks during site selection and involving the sponsor when critical issues arise.
"When faced with site-specific issues that may affect data integrity or product safety, the CRA should consult with the sponsor before making a final decision." Objectives:
* Ensuring proper site selection
* Managing potential risks proactively


NEW QUESTION # 101
A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

  • A. Complete
  • B. Original
  • C. Attributable
  • D. Contemporaneous

Answer: A

Explanation:
The missing data indicates a lack of completeness in the study documentation. Completeness is a fundamental requirement in clinical trials, as all necessary information must be recorded accurately and in full. Missing vital signs such as heart rate and temperature can compromise the validity of the data and affect the study's outcomes.
GCP guidelines state that all data collected during the study must be complete, accurate, and consistent with source documents.
"Clinical trial documentation must be complete, containing all data as required by the protocol toensure data integrity." Objectives:
* Ensure comprehensive data recording.
* Maintain accuracy and completeness in study records.


NEW QUESTION # 102
A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

  • A. Crossover
  • B. Factorial
  • C. Parallel Group
  • D. Group sequential

Answer: A

Explanation:
A crossover study design involves participants receiving multiple interventions sequentially, with a washout period in between to minimize carryover effects. This design allows each participant to serve as their own control, increasing statistical power while reducing variability. It is commonly used when comparing two treatments or interventions.
GCP guidelines classify a crossover design as one where subjects receive multiple treatments in a specified sequence.
"In crossover trials, participants receive each intervention in a specific order, allowing for within-subject comparison." Objectives:
* Understand the structure of crossover studies.
* Improve statistical efficiency through self-control comparisons.


NEW QUESTION # 103
A deferred consent can take place in which of the following situations?

  • A. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
  • B. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
  • C. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
  • D. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.

Answer: A

Explanation:
Deferred consent is permissible in emergency situations where immediate intervention is necessary and obtaining prior consent is not feasible. However, this practice must be explicitly described in the protocol and approved by the ethics committee. This ensures that the rights of patients are protected even in urgent circumstances.
GCP guidelines emphasize that deferred consent is only allowed when pre-approved by the ethics committee as part of the protocol for emergency interventions.
"In emergencies, deferred consent is permitted only if outlined in the protocol and approved by the ethics committee, ensuring compliance with ethical standards." Objectives:
* Protect patient rights in emergency research.
* Ensure ethical approval for deferred consent.


NEW QUESTION # 104
A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

  • A. They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
  • B. They cannot be the PI on the clinical study due to conflict of interest.
  • C. They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
  • D. They can attend the meeting and can vote/provide opinion on whether to approve the study.

Answer: A

Explanation:
If a PI is also a member of the IRB/IEC, they must recuse themselves from the meeting when their own study is being reviewed to avoid conflicts of interest. This practice preserves the objectivity and impartiality of the IRB/IEC's decisions.
The answer is verified based on IRB/IEC operational guidelines, which mandate that members with potential conflicts recuse themselves from discussions and voting.
"To maintain objectivity, IRB/IEC members who have a conflict of interest related to a study must recuse themselves from the review and decision-making process." Objectives:
* Maintain impartiality in IRB/IEC decisions
* Prevent conflicts of interest in clinical trial approval


NEW QUESTION # 105
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