Reliable ACRP-CP Exam Syllabus, ACRP-CP Exams Collection
Reliable ACRP-CP Exam Syllabus, ACRP-CP Exams Collection
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Tags: Reliable ACRP-CP Exam Syllabus, ACRP-CP Exams Collection, Valid ACRP-CP Mock Exam, Reliable ACRP-CP Study Guide, Certification ACRP-CP Test Answers
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ACRP Certified Professional Exam Sample Questions (Q83-Q88):
NEW QUESTION # 83
Who determines the age of assent for pediatric studies?
- A. IRB/IEC
- B. PI
- C. Sponsor
- D. Parent
Answer: A
Explanation:
The IRB/IEC determines the age at which a child is considered capable of providing assent for participation in a clinical trial. This decision is based on local regulations, cultural considerations, and the child's ability to understand the trial's risks and benefits. The age of assent may vary between jurisdictions and is subject to ethical considerations specific to pediatric research.
GCP guidelines emphasize that the IRB/IEC is responsible for setting the criteria for obtaining assent from minors based on ethical and regulatory frameworks.
"The IRB/IEC is responsible for determining the age and circumstances under which pediatric assent is required, considering the child's comprehension level." Objectives:
* Ensure appropriate ethical practices in pediatric research.
* Align with local regulatory requirements for assent.
NEW QUESTION # 84
A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?
- A. Investigator
- B. Health authority
- C. Sponsor
- D. DSMB/IDMC
Answer: C
Explanation:
The sponsor is responsible for updating the Investigator's Brochure (IB) with new information obtained from the completed Phase I trial. The IB must reflect the most current data on the drug's safety, efficacy, and dosing to support Phase II planning and execution.
According to GCP guidelines, the sponsor must ensure that the IB is updated regularly with relevant findings from ongoing and completed trials.
"The sponsor is responsible for ensuring that the Investigator's Brochure is updated with the latest safety and efficacy data before advancing to the next phase of the trial." Objectives:
* Keep the IB current and accurate.
* Inform investigators of the latest safety and efficacy data.
NEW QUESTION # 85
Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?
- A. Administer rescue medication.
- B. Consult the IB.
- C. Call the medical monitor.
- D. Report the AE to the sponsor.
Answer: A
Explanation:
In a life-threatening situation, the investigator's first priority is the safety and well-being of the participant.
Administering rescue medication immediately is critical to stabilize the patient, regardless of protocol restrictions. Ethical considerations and patient safety always take precedence over protocol compliance.
GCP guidelines emphasize that subject safety is the primary concern, and appropriate medical care must be administered in emergencies.
"In cases of life-threatening events, the investigator should administer necessary medical interventions to safeguard the subject's health." Objectives:
* Prioritize patient safety in emergency situations.
* Make decisions based on medical necessity rather than protocol restrictions.
NEW QUESTION # 86
Which of the following should be considered when implementing a risk-based monitoring plan?
- A. Monitoring schedule must be pre-defined in the monitoring plan.
- B. On-site monitoring frequency may change depending on the quality of the data.
- C. 100% source document review is mandatory.
- D. Centralized monitoring must be incorporated in any trials.
Answer: B
Explanation:
Risk-based monitoring focuses on adapting the frequency and intensity of on-site visits based on data quality and site performance. If the data is consistently accurate and reliable, the monitoring frequency may be reduced. Conversely, if issues are identified, more frequent monitoring may be necessary.
GCP guidelines emphasize a flexible approach to monitoring, allowing adjustments based on the risk profile and quality of data collected.
"Risk-based monitoring involves adapting the frequency of on-site visits according to the quality of the data and the site's compliance level." Objectives:
* Implement a dynamic monitoring strategy.
* Enhance efficiency while maintaining data integrity.
NEW QUESTION # 87
A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:
- A. Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
- B. Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.
- C. Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.
- D. Reject the null hypothesis that the drug has no effect on cholesterol levels.
Answer: D
Explanation:
The purpose of statistical analysis in a clinical trial is to evaluate whether the data supports rejecting the null hypothesis, which typically states that there is no effect or difference. If the analysis finds a statistically significant result, the null hypothesis is rejected, indicating that the investigational drug has an effect on cholesterol levels.
The answer follows statistical principles in clinical trials, where the null hypothesis is rejected if evidence shows a significant difference or effect.
"In hypothesis testing, rejecting the null hypothesis indicates that the treatment effect is statistically significant." Objectives:
* Understand hypothesis testing in clinical research.
* Interpret statistical outcomes accurately.
NEW QUESTION # 88
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