SOCRA Introduction Exam Questions
and Answers |100% Correct| 2024/2025
Latest Version!!
What is the primary purpose of the SOCRA certification?
To validate the knowledge and skills of clinical research professionals.
Which of the following is a key principle of Good Clinical Practice (GCP)?...
SOCRA Introduction Exam Questions
and Answers |100% Correct| 2024/2025
Latest Version!!
What is the primary purpose of the SOCRA certification?
To validate the knowledge and skills of clinical research professionals.
Which of the following is a key principle of Good Clinical Practice (GCP)?
Ensuring the rights, safety, and well-being of trial participants are prioritized.
What is the significance of the informed consent process in clinical trials?
To ensure participants are fully aware of the study's risks and benefits before agreeing to
participate.
Which document outlines the ethical and scientific rationale for a clinical trial?
The Clinical Trial Protocol.
What role does the Institutional Review Board (IRB) play in clinical research?
To protect the rights and welfare of human research subjects by reviewing and approving
research proposals.
What is the purpose of randomization in clinical trials?
To eliminate bias in the assignment of participants to treatment groups.
1
,What is an adverse event in the context of clinical research?
Any undesirable experience associated with the use of a medical product in a patient.
What are inclusion criteria in a clinical trial?
The specific characteristics that participants must have to be eligible for the study.
How often must investigators report study progress to the IRB?
Typically annually, but this may vary based on the study and IRB requirements.
What is the primary responsibility of the sponsor in a clinical trial?
To oversee the planning, implementation, and management of the clinical trial.
What does the term "blinding" refer to in clinical trials?
A method used to prevent bias by keeping participants or investigators unaware of treatment
assignments.
What is the significance of the Investigator's Brochure?
It provides detailed information about the investigational product for investigators and ethics
committees.
What is the role of a Clinical Research Associate (CRA)?
To monitor clinical trial sites and ensure compliance with the protocol and regulations.
2
, What does a case report form (CRF) contain?
Data collected from each participant during the clinical trial.
What is a serious adverse event (SAE)?
An event that results in death, hospitalization, or significant disability during a clinical trial.
What is the purpose of a Data Safety Monitoring Board (DSMB)?
To review data for safety and efficacy and recommend whether to continue or modify the trial.
What constitutes a protocol deviation?
Any change to the protocol that occurs without prior IRB approval.
What is the main goal of Phase I clinical trials?
To assess the safety, tolerability, and pharmacokinetics of a drug in a small group of participants.
What does pharmacovigilance involve?
Monitoring the safety of a drug after it has been approved for use in the general population.
What is required for informed consent to be valid?
3
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