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ACRP Certified Professional Exam Sample Questions (Q68-Q73):
NEW QUESTION # 68
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
- A. Blinding
- B. Privacy controls
- C. Randomization
- D. Placebo-controlled
Answer: C
Explanation:
Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.
GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.
"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups." Objectives:
* Maintain scientific rigor through randomization.
* Minimize selection bias in clinical studies.
NEW QUESTION # 69
What would a sponsor use to implement and maintain quality in a study?
- A. Protocol signature pages
- B. Standard operating procedures
- C. Statistical analysis plan
- D. Clinical trial agreement
Answer: B
Explanation:
Standard Operating Procedures (SOPs) are essential for implementing and maintaining quality in a clinical study. SOPs outline the standardized methods for conducting study-related tasks, ensuring consistency, compliance, and quality across all trial sites. They are critical for training personnel, guiding the conduct of study activities, and maintaining protocol adherence.
GCP guidelines state that sponsors must develop and maintain SOPs to ensure the quality and consistency of clinical trial processes.
"The sponsor should establish SOPs to maintain the quality of clinical trials, covering all aspects of trial conduct, data handling, and safety management." Objectives:
* Ensure consistent and high-quality trial conduct.
* Standardize procedures across trial sites.
NEW QUESTION # 70
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. Occurrence of known side effects of the IP
- B. Use of concomitant medications to treat the symptoms
- C. Time to occurrence of symptoms of the disease
- D. Impact of an approved vaccine against the disease
Answer: C
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 # 71
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. 3.0 mg/dL
- B. 3.6 mg/dL
- C. 1.8 mg/dL
- D. 2.6 mg/dL
Answer: A
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 # 72
Which of the following is a conflict of interest for a PI conducting a study?
- A. A PI that votes on the IRB/IEC approval of the protocol
- B. A PI who receives payment for the study
- C. A PI that presents at an investigator meeting
- D. A PI who is a key opinion leader, writes the protocol
Answer: A
Explanation:
A Principal Investigator (PI) who is involved in voting on the IRB/IEC approval of their own protocol is considered to have a conflict of interest. The IRB/IEC must be independent and impartial when reviewing research proposals. Allowing the PI to vote on their own study compromises the ethical review process. To maintain unbiased decision-making, PIs must recuse themselves from such votes.
GCP guidelines emphasize the importance of avoiding conflicts of interest in the IRB/IEC decision-making process to maintain objectivity and ethical standards.
"A PI should not participate in voting or decision-making processes regarding the approval of their own study to avoid conflicts of interest." Objectives:
* Maintain impartiality in ethical review.
* Prevent conflicts of interest during IRB/IEC processes.
NEW QUESTION # 73
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