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ACRP Certified Professional Exam Sample Questions (Q101-Q106):

NEW QUESTION # 101
When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A. Participant verbally agreed to the PD.
B. PD affected participant recruitment.
C. PD affected participant safety.
D. Sponsor approved the PD.

Answer: C

Explanation:
The primary factor in determining whether a protocol deviation should be reported to the IRB/IEC is whether the deviation impacts participant safety or the integrity of the study data. Any deviation that could pose a risk to participants must be reported promptly to ensure ongoing ethical oversight.
GCP guidelines mandate reporting of any protocol deviations that affect safety or data integrity to the IRB
/IEC.
"Protocol deviations that impact the safety of participants or the integrity of the study must be reported to the IRB/IEC." Objectives:
* Maintain participant safety.
* Ensure regulatory compliance through prompt reporting.

NEW QUESTION # 102
IP is dispensed to all subjects who:

A. Are eligible to receive it in the trial.
B. Consented for the trial.
C. Screened for the trial.
D. Need IP for their medical condition.

Answer: A

Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.

NEW QUESTION # 103
The IB contains which of the following sections?

A. Known pharmacokinetic effects
B. IP preparation instructions
C. Participant dosing schedule
D. Participant eligibility criteria

Answer: A

Explanation:
The Investigator's Brochure (IB) contains comprehensive information about the investigational product (IP), including its pharmacokinetic and pharmacodynamic properties, preclinical and clinical trial data, and any known side effects. The IB provides a scientific basis for the study protocol and helps investigators understand the potential risks and benefits.
GCP guidelines state that the IB must include relevant scientific data, including pharmacokinetic and pharmacodynamic profiles.
"The IB should provide data on the pharmacokinetics and pharmacodynamics of the investigational product to inform clinical practice." Objectives:
* Provide comprehensive data on investigational products.
* Support safe and informed clinical decision-making.

NEW QUESTION # 104
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A. Sponsor.
B. Regulatory authority.
C. Medical monitor.
D. IRB/IEC.

Answer: A

Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.

NEW QUESTION # 105
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A. Risk-based audits of CRO activities as delegated
B. Pre-qualification assessment of CRO
C. Central monitoring of data fields by sponsor
D. Co-monitoring of CRO site visits

Answer: A

Explanation:
Risk-based audits of CRO activities as delegated are considered the most efficient way of overseeing a CRO's management. This approach focuses on evaluating the critical risks that might impact data integrity and participant safety. It allows sponsors to allocate resources to areas with the highest potential for error or deviation, rather than performing exhaustive monitoring of all activities.
The answer is verified as per guidelines on risk-based monitoring strategies, emphasizing targeted and efficient oversight of CRO functions.
"Risk-based monitoring emphasizes focusing on critical study parameters and the risks that have the potential to affect data quality and subject safety." Objectives:
* Efficient management of outsourced clinical trial tasks.
* Ensuring data integrity through targeted audits.

NEW QUESTION # 106
......

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ACRP-CP exam dumps & ACRP-CP torrent vce & ACRP-CP study pdf

ACRP ACRP-CP Sample Exam, ACRP-CP Braindumps Downloads

ACRP Certified Professional Exam Sample Questions (Q101-Q106):

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