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ACRP Certified Professional Exam Sample Questions (Q83-Q88):
NEW QUESTION # 83
The PI may assign responsibility for IP accountability to the pharmacist provided they are:
- A. Approved by the IRB/IEC.
- B. Licensed to practice medicine.
- C. An employee of the institution.
- D. Under the supervision of the PI.
Answer: D
Explanation:
The Principal Investigator (PI) can delegate the responsibility for investigational product (IP) accountability to a pharmacist as long as the pharmacist operates under the PI's supervision. This ensures that the pharmacist's actions remain compliant with the protocol and regulatory requirements.
According to GCP guidelines, the PI retains overall responsibility for IP management, even when tasks are delegated to other qualified staff members.
"The investigator may delegate IP management responsibilities to a pharmacist, provided the pharmacist works under the PI's direct supervision." Objectives:
* Maintain accountability for investigational products.
* Ensure proper delegation of IP responsibilities.
NEW QUESTION # 84
SAEs must be reported immediately by the site to the:
- A. Regulatory agency.
- B. DSMB/IDMC.
- C. IRB/IEC.
- D. Sponsor.
Answer: D
Explanation:
Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.
GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.
"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements." Objectives:
* Ensure rapid reporting of serious adverse events.
* Maintain safety monitoring during the trial.
NEW QUESTION # 85
A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:
- A. Phase I
- B. Phase II
- C. Phase IV
- D. Phase III
Answer: B
Explanation:
A Phase II clinical trial is typically conducted to evaluate the efficacy of a drug, determine the optimal dosing regimen, and further assess its safety profile. Since the objective is to establish the effective dose and regimen for hypothyroidism treatment, this clearly falls under Phase II.
GCP guidelines categorize Phase II trials as those aimed at determining efficacy and optimal dosing of investigational products.
"Phase II trials focus on determining the therapeutic efficacy, optimal dosage, and further evaluating the safety of the investigational product." Objectives:
* Identify effective dosing regimens.
* Evaluate therapeutic efficacy for targeted conditions.
NEW QUESTION # 86
Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?
- A. Call the participant to return for an unscheduled visit.
- B. Notify the PI.
- C. Report a protocol deviation to the IRB/IEC.
- D. Notify the sponsor.
Answer: B
Explanation:
The CRC's first responsibility is to immediately inform the Principal Investigator (PI), who is responsible for the participant's medical care. The PI will assess the situation, determine the potential risk, and initiate appropriate clinical actions to ensure the participant's safety. This may include medical evaluation or adjusting the dosing regimen.
According to GCP guidelines, any issue that may affect participant safety should be promptly communicated to the PI to ensure appropriate medical management.
"The investigator must be informed immediately of any events that could compromise participant safety, allowing for prompt clinical decision-making." Objectives:
* Ensure rapid response to dosing errors.
* Maintain participant safety as a priority.
NEW QUESTION # 87
In a quality management system, in which category do risk reduction activities belong?
- A. Risk Communication
- B. Risk Evaluation
- C. Risk Review
- D. Risk Control
Answer: D
Explanation:
Risk reduction activities fall underRisk Controlwithin a Quality Management System (QMS). Risk control involves implementing measures to reduce identified risks to an acceptable level, including corrective actions, preventive measures, and continuous monitoring. It aims to mitigate potential negative impacts on trial integrity and participant safety.
GCP guidelines highlight that risk control encompasses actions taken to minimize the likelihood and impact of identified risks.
"Risk control is the process of implementing measures to mitigate risks identified during the risk assessment phase." Objectives:
* Implement effective risk management strategies.
* Ensure proactive risk mitigation in clinical trials.
NEW QUESTION # 88
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