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ACRP Certified Professional Exam Sample Questions (Q58-Q63):

NEW QUESTION # 58
A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A. After the original planned data collection is completed
B. When the need for the additional data is discovered
C. After the protocol amendment is approved by the IRB/IEC
D. As soon as the protocol amendment is submitted to the IRB/IEC

Answer: C

Explanation:
The research team must wait until the protocol amendment is reviewed and approved by the IRB/IEC before collecting any additional data. This ensures that any changes to the data collection process have undergone ethical review and comply with regulatory requirements. Collecting data without IRB/IEC approval would be a violation of Good Clinical Practice (GCP).
GCP guidelines clearly state that any changes to the protocol, including additional data collection, must be approved by the IRB/IEC before implementation.
"Any amendment that affects participant data collection must receive IRB/IEC approval before the change is implemented." Objectives:
* Maintain compliance with ethical standards.
* Protect participants' rights and data integrity.

NEW QUESTION # 59
Source data/documentation should be:

A. Attributable, legible, correct, original, accurate, and complete.
B. Attributable, legible, contemporaneous, original, accurate, and complete.
C. Attributable, legible, contemporaneous, original, accurate, and clear.
D. Attributable, legible, correct, original, accurate, and clear.

Answer: B

Explanation:
Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high- quality, reliable, and verifiable clinical trial records.
GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.
"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards." Objectives:
* Maintain data integrity and reliability.
* Adhere to best practices in clinical documentation.

NEW QUESTION # 60
All of the following are examples of what monitors review EXCEPT:

A. The signed ICF retained in the participant's study file.
B. Regulatory binder which includes copies of current certifications for all laboratories.
C. Documentation in the participant's medical record of study drug administration.
D. Potential patient medical records for eligibility prior to the informed consent process.

Answer: D

Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration.
However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations." Objectives:
* Understand the scope of monitoring responsibilities.
* Protect patient confidentiality during the monitoring process.

NEW QUESTION # 61
A root cause analysis should be:

A. Specific to a clinical trial.
B. Written by the investigator.
C. Focused on issues of non-compliance.
D. Validated before use in a CAPA.

Answer: C

Explanation:
Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non- compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non- compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively." Objectives:
* Address non-compliance systematically.
* Develop effective CAPA plans.

NEW QUESTION # 62
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A. Placebo-controlled
B. Randomization
C. Blinding
D. Privacy controls

Answer: B

Explanation:
Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.
GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.
"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups." Objectives:
* Maintain scientific rigor through randomization.
* Minimize selection bias in clinical studies.

NEW QUESTION # 63
......

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Reliable ACRP-CP Exam Syllabus | ACRP-CP Examcollection Dumps Torrent

ACRP ACRP-CP Exam Dumps with Guaranteed Success Result [2025]

ACRP Certified Professional Exam Sample Questions (Q58-Q63):

Quiz 2025 ACRP ACRP-CP: ACRP Certified Professional Exam – High-quality Reliable Exam Syllabus

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