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Keith Shaw Keith Shaw

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ACRP Certified Professional Exam Sample Questions (Q116-Q121):

NEW QUESTION # 116
Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A. How willing are current patients to participate in a trial with potentially serious side effects?
B. How effective is the drug at treating patients that have been previously diagnosed with cancer?
C. How likely are patients at high risk of cancer going to develop cancer during the study?
D. How does the risk of developing cancer compare to the anticipated side effects from the drug?

Answer: D

Explanation:
Before initiating a clinical trial with a drug that has potentially serious side effects, it is essential to evaluate the risk-benefit ratio. The primary consideration is whether the potential benefits (reduced cancer risk) outweigh the risks (serious side effects). This assessment is fundamental to ethical clinical trial design.
The answer is verified as per GCP and ethical guidelines, which require a thorough assessment of risk versus benefit before conducting human trials.
"An assessment of potential benefits versus risks is a fundamental principle in the ethical design of clinical trials, especially when potential adverse effects are severe." Objectives:
* Ensure ethical considerations in trial design.
* Assess the potential harm versus benefit to participants.

NEW QUESTION # 117
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A. IRB/IEC.
B. Sponsor.
C. Medical monitor.
D. Regulatory authority.

Answer: B

Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.

NEW QUESTION # 118
A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

A. Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.
B. Reject the null hypothesis that the drug has no effect on cholesterol levels.
C. Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.
D. Reject the alternative hypothesis that the drug has no effect on cholesterol levels.

Answer: B

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 # 119
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. Health authority
B. DSMB/IDMC
C. Sponsor
D. Investigator

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 # 120
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A. 30 calendar days
B. 8 calendar days
C. 15 calendar days
D. 7 calendar days

Answer: C

Explanation:
The sponsor is required to report serious unexpected adverse events (SAEs) to the regulatory authorities within 15 calendar days from the date of awareness. This reporting period is mandated to ensure that any new safety information that may affect the risk/benefit profile of the investigational product (IP) is promptly communicated, thereby protecting participant safety.
GCP guidelines specify that serious, unexpected, and related AEs must be reported to regulatory authorities within 15 days of being known to the sponsor.
"Serious unexpected adverse reactions that may affect the safety profile of the IP must be reported within 15 calendar days to the regulatory authorities." Objectives:
* Ensure timely reporting of safety information.
* Protect the safety of trial participants.

NEW QUESTION # 121
......

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