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ACRP Certified Professional Exam Sample Questions (Q115-Q120):
NEW QUESTION # 115
A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?
- A. Parallel Group
- B. Group sequential
- C. Crossover
- D. Factorial
Answer: C
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 # 116
The coding system for a double-blind clinical trial is accessible by the:
- A. IRB/IEC
- B. PI
- C. Sponsor
- D. Regulatory authority
Answer: C
Explanation:
The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.
GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.
"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study's integrity." Objectives:
* Maintain the integrity of double-blind trials.
* Allow controlled access to randomization codes.
NEW QUESTION # 117
A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?
- A. Notify the sponsor.
- B. Notify the subject.
- C. Notify the regulatory authority.
- D. Withdraw the subject.
Answer: A
Explanation:
When a protocol deviation is identified, especially one involving inclusion criteria, the sponsor must be notified immediately. The sponsor will assess the deviation and determine whether the subject can continue in the study. Early notification ensures appropriate action and compliance with protocol and regulatory guidelines.
This answer aligns with GCP principles that mandate sponsor notification in case of protocol deviations, especially when they may impact participant safety or data integrity.
"Any deviation from the protocol that affects subject eligibility must be reported to the sponsor immediately for evaluation and guidance." Objectives:
* Maintain adherence to protocol inclusion criteria.
* Report deviations promptly for safety assessment.
NEW QUESTION # 118
Which of the following is a conflict of interest for a PI conducting a study?
- A. A PI who receives payment for the study
- B. A PI that votes on the IRB/IEC approval of the protocol
- C. A PI that presents at an investigator meeting
- D. A PI who is a key opinion leader, writes the protocol
Answer: B
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 # 119
Who ensures information regarding payments to subjects is documented in a written consent form?
- A. PI
- B. Coordinator
- C. Sponsor
- D. IRB/IEC
Answer: D
Explanation:
The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.
The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.
"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants." Objectives:
* Guaranteeing informed consent quality
* Ensuring transparency about participant payments
NEW QUESTION # 120
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