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ACRP Certified Professional Exam Sample Questions (Q27-Q32):
NEW QUESTION # 27
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. Withdraw the subject.
- C. Notify the regulatory authority.
- D. Notify 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 # 28
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?
- A. Interview participants who have dropped out.
- B. Meet with the site staff to understand their workflows and to review retention strategies.
- C. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
- D. Require participants to provide documented reason for withdrawal.
Answer: B
Explanation:
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.
NEW QUESTION # 29
Which of the following elements of the Informed Consent are NOT required?
- A. A description of any reasonably foreseeable risks or discomforts
- B. A description of potential benefits
- C. Subject legal rights can be waived
- D. Statement that study involves research
Answer: C
Explanation:
Informed consent must not include any language that implies a waiver of the participant's legal rights or releases the investigator, sponsor, or institution from liability for negligence. Such language violates ethical standards and the principles of voluntary participation.
According to GCP guidelines and ethical principles, the informed consent document must not include any clause that waives a participant's legal rights.
"An informed consent form must not include language that waives the participant's legal rights or releases the sponsor or investigator from liability." Objectives:
* Protect participant rights in clinical trials.
* Ensure that consent is given voluntarily and ethically.
NEW QUESTION # 30
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?
- A. Conduct routine investigators' meetings
- B. Draft a CAPA plan
- C. Establish a DSMB/IDMC
- D. Develop a monitoring plan
Answer: C
Explanation:
A Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) is established to review ongoing trial data at regular intervals. The DSMB evaluates safety, progress, and efficacy endpoints and makes recommendations to continue, modify, or terminate the study based on interim data. This independent oversight helps ensure participant safety and data integrity throughout the trial.
GCP guidelines recommend forming a DSMB for studies that involve high risks or long durations, ensuring continuous safety monitoring.
"The DSMB is responsible for the periodic review of accumulating data and providing recommendations regarding trial continuation, modification, or termination." Objectives:
* Ensure ongoing safety evaluation.
* Facilitate objective decisions on trial continuation.
NEW QUESTION # 31
Which document confirms the PI's agreement to permit auditing at the study site?
- A. IB
- B. Protocol
- C. ICF
- D. Delegation Log
Answer: C
Explanation:
The Informed Consent Form (ICF) typically includes a statement indicating that the participant's records may be reviewed by monitors, auditors, and regulatory authorities. This ensures transparency and compliance with regulatory requirements, allowing for audits and inspections when necessary.
This answer follows GCP guidelines which specify that the ICF should include consent for audits and inspections to protect subject confidentiality while ensuring data integrity.
"The ICF must include a statement allowing access to trial data for monitoring, auditing, and regulatory inspection purposes." Objectives:
* Ensure informed consent for data access.
* Facilitate compliance with auditing requirements.
NEW QUESTION # 32
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