SOCRA (CCRP) Complete Mock Exam
Questions and Answers |100% Correct|
2024/2025 Latest Version!!
What is the primary focus of Good Clinical Practice (GCP) guidelines?
To ensure the safety and well-being of trial participants while obtaining reliable data.
Which document outlines the detaile...
SOCRA (CCRP) Complete Mock Exam
Questions and Answers |100% Correct|
2024/2025 Latest Version!!
What is the primary focus of Good Clinical Practice (GCP) guidelines?
To ensure the safety and well-being of trial participants while obtaining reliable data.
Which document outlines the detailed plan for a clinical trial?
Clinical Trial Protocol
What is the role of the Institutional Review Board (IRB) in clinical research?
To review and approve the ethical aspects of research studies involving human subjects.
What does informed consent require from participants in a clinical trial?
A thorough understanding of the study's purpose, procedures, risks, and benefits before
participation.
What is a serious adverse event (SAE) in clinical research?
Any event that results in death, hospitalization, or significant disability that occurs during a
clinical trial.
Which phase of clinical trials is primarily concerned with evaluating the drug’s efficacy?
Phase II
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, What is the main purpose of the Investigator's Brochure?
To provide information about the investigational product to investigators and ethics committees.
What is the significance of randomization in clinical trials?
It helps eliminate bias in assigning participants to treatment groups.
When must serious adverse events be reported to the IRB?
Immediately or within a specified time frame, typically within 24 to 48 hours.
What is the function of a Data Monitoring Committee (DMC)?
To review data for safety and efficacy during the trial and provide recommendations.
What constitutes a protocol deviation?
Any change to the protocol that occurs without prior IRB approval.
What is the primary responsibility of the sponsor in a clinical trial?
To initiate, manage, and finance the clinical trial.
Which of the following is a key responsibility of a Clinical Research Associate (CRA)?
To monitor trial sites and ensure compliance with the study protocol and regulations.
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