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ACRP Certified Professional Exam Sample Questions (Q106-Q111):

NEW QUESTION # 106
Source data/documentation should be:

A. Attributable, legible, correct, original, accurate, and complete.
B. Attributable, legible, contemporaneous, original, accurate, and clear.
C. Attributable, legible, correct, original, accurate, and clear.
D. Attributable, legible, contemporaneous, original, accurate, and complete.

Answer: D

Explanation:
Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high- quality, reliable, and verifiable clinical trial records.
GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.
"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards." Objectives:
* Maintain data integrity and reliability.
* Adhere to best practices in clinical documentation.

NEW QUESTION # 107
The inclusion and exclusion criteria are in place so all subjects are:

A. Healthy and willing to complete the clinical trial.
B. Patients with the disease under study and will not have any adverse events.
C. Ethically vulnerable and patients with the disease under study.
D. Medically appropriate and protected from ethical vulnerability.

Answer: D

Explanation:
Inclusion and exclusion criteria are designed to ensure that participants are medically appropriate for the study and are not ethically vulnerable. This reduces risks to subjects and ensures that the collected data accurately reflects the target population.
The answer follows GCP principles that emphasize participant safety and data validity through well-defined inclusion/exclusion criteria.
"Inclusion and exclusion criteria are crucial for ensuring the safety of participants and the scientific validity of study results." Objectives:
* Ensuring participant safety.
* Maintaining ethical standards in clinical research.

NEW QUESTION # 108
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 likely are patients at high risk of cancer going to develop cancer during the study?
B. How effective is the drug at treating patients that have been previously diagnosed with cancer?
C. How willing are current patients to participate in a trial with potentially serious side effects?
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 # 109
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A. Investigators participating in the trial.
B. Independent qualified individuals.
C. Regulatory authority expert advisors.
D. Executive board members.

Answer: B

Explanation:
Interim analysis should be reviewed by independent qualified individuals, such as members of a Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC). This ensures that the analysis is unbiased and that decisions regarding continuation, modification, or termination of the trial are made objectively.
GCP guidelines emphasize that interim data should be reviewed by an independent committee to prevent bias and ensure participant safety.
"Interim analyses should be conducted by independent experts to maintain objectivity and safeguard trial integrity." Objectives:
* Maintain impartiality during interim analysis.
* Ensure unbiased decision-making regarding trial continuation.

NEW QUESTION # 110
A study protocol must contain which of the following elements?

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

Answer: D

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 # 111
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