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SoCRA Re-Certification Exam 2025/2024 Questions and Answers |100% Correct| Latest Version £7.46
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SoCRA Re-Certification Exam 2025/2024 Questions and Answers |100% Correct| Latest Version

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SoCRA Re-Certification Exam 2025/2024 Questions and Answers |100% Correct| Latest Version What is the primary focus of Good Clinical Practice (GCP) guidelines? To ensure the ethical and scientific quality of clinical trials. What is an essential component of the informed consent process? ...

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  • October 15, 2024
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SoCRA Re-Certification Exam 2025/2024
Questions and Answers |100% Correct|
Latest Version
What is the primary focus of Good Clinical Practice (GCP) guidelines?

To ensure the ethical and scientific quality of clinical trials.



What is an essential component of the informed consent process?

Providing potential participants with a clear explanation of study risks and benefits.



How is a "serious adverse event" (SAE) defined?

An event that results in death, life-threatening conditions, hospitalization, or disability.



What does "protocol deviation" mean in clinical research?

A departure from the approved study protocol that can impact study outcomes.



What is the role of the Institutional Review Board (IRB) in clinical trials?

To review and approve research proposals to ensure the protection of human subjects.



What does "randomization" in a clinical trial aim to achieve?

To eliminate selection bias by randomly assigning participants to different treatment groups.



What is the primary purpose of a Data Safety Monitoring Board (DSMB)?
1

, To monitor participant safety and treatment efficacy during a clinical trial.



What type of study design allows for the comparison of outcomes between treatment and control

groups?

A randomized controlled trial.



What does the acronym "CRA" stand for in clinical research?

Clinical Research Associate.



What is a common reason for an IRB to disapprove a study protocol?

Concerns regarding participant safety or ethical considerations.



What is the significance of maintaining accurate case report forms (CRFs)?

They serve as the primary source of data for regulatory submissions and statistical analysis.



How often should adverse events be reported to the IRB?

Typically, within a specific timeframe, such as within 24 hours for serious events.



What does the term "inclusion criteria" refer to in clinical trials?

The specific characteristics that participants must meet to be eligible for the study.



What is the main purpose of Phase I clinical trials?


2

, To assess the safety and dosage of a new drug in a small group of participants.



What is "informed assent" in pediatric research?

A process where minors are provided with age-appropriate information to understand the

study.



What is the definition of a "placebo"?

An inactive substance given to a control group in a clinical trial for comparison with the

treatment group.



What does "blinding" help to reduce in clinical trials?

The potential for bias in participant responses and researcher assessments.



What is the role of the study sponsor in clinical research?

To oversee the conduct of the study and ensure compliance with regulations.



What is the purpose of conducting a feasibility study before a clinical trial?

To assess the practicality and potential success of the trial at selected sites.



How are "exclusion criteria" determined for a clinical trial?

To identify characteristics that disqualify potential participants to ensure safety and validity.




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