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ACRP Certified Professional Exam Sample Questions (Q44-Q49):

NEW QUESTION # 44
The composition of an IDMC/DSMB should include which one of the following?

A. A clinical scientist who is knowledgeable in the appropriate discipline
B. A lead PI for the study
C. A sponsor representative who is knowledgeable about the study's unblinded information
D. A member from the IRB/IEC

Answer: A

Explanation:
An Independent Data Monitoring Committee (IDMC) or Data and Safety Monitoring Board (DSMB) should include clinical scientists who are knowledgeable in the relevant medical and scientific areas. Their role is to objectively assess the ongoing safety data and efficacy of the investigational product, ensuring that participants' safety is not compromised.
GCP guidelines emphasize the need for experienced clinical scientists on IDMC/DSMBs to ensure that safety data is interpreted accurately and professionally.
"IDMC/DSMB should comprise independent experts, including clinical scientists, who have the expertise to evaluate safety and efficacy data objectively." Objectives:
* Ensure impartial evaluation of safety data.
* Maintain scientific integrity in monitoring clinical trials.

NEW QUESTION # 45
A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

A. Continue reporting temperature excursions per the pharmacy manual guidelines.
B. Install an air cooler requiring regular water refills to maintain the room temperature.
C. Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
D. Return all IP and request the CRO/Sponsor to directly ship IP to participants.

Answer: C

Explanation:
Investing in a temperature-controlled IP cabinet is the most effective and sustainable solution for maintaining IP stability. This cabinet can consistently regulate temperature without relying on external A/C systems, thereby minimizing the risk of excursions and ensuring compliance with storage requirements.
GCP guidelines state that IP must be stored under controlled conditions as specified by the protocol and product labeling.
"Temperature-controlled storage units should be used when site environmental conditions are not reliable to maintain IP stability." Objectives:
* Ensure IP stability and compliance.
* Mitigate temperature excursion risks effectively.

NEW QUESTION # 46
A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A. Worksheet.
B. PRO.
C. CRF.
D. Source document.

Answer: C

Explanation:
A Case Report Form (CRF) is a tool used in clinical trials to collect data as specified by the protocol. It is a printed, optical, or electronic document designed to record all protocol-required information for each trial subject. CRFs are crucial for ensuring that the data collected during the trial is accurate, complete, and consistent with the protocol.
This answer follows GCP guidelines, which describe CRFs as essential documents for capturing and transmitting study data to the sponsor.
"A Case Report Form (CRF) is a printed, optical, or electronic document specifically designed to record all protocol-required information to be reported to the sponsor on each trial subject." Objectives:
* Understand the role of CRFs in clinical trials.
* Ensure accurate and complete data collection.

NEW QUESTION # 47
Who determines the age of assent for pediatric studies?

A. IRB/IEC
B. Sponsor
C. Parent
D. PI

Answer: A

Explanation:
The IRB/IEC determines the age at which a child is considered capable of providing assent for participation in a clinical trial. This decision is based on local regulations, cultural considerations, and the child's ability to understand the trial's risks and benefits. The age of assent may vary between jurisdictions and is subject to ethical considerations specific to pediatric research.
GCP guidelines emphasize that the IRB/IEC is responsible for setting the criteria for obtaining assent from minors based on ethical and regulatory frameworks.
"The IRB/IEC is responsible for determining the age and circumstances under which pediatric assent is required, considering the child's comprehension level." Objectives:
* Ensure appropriate ethical practices in pediatric research.
* Align with local regulatory requirements for assent.

NEW QUESTION # 48
The IB contains which of the following sections?

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

Answer: C

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 # 49
......

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Latest ACRP ACRP-CP Test Format - Valid ACRP-CP Exam Duration

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ACRP Certified Professional Exam Sample Questions (Q44-Q49):

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