SOCRA (Society of Clinical Research Associates) Final Exam Questions and Answers |100% Correct| 2024/2025 Latest Version
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SOCRA
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SOCRA
SOCRA (Society of Clinical Research
Associates) Final Exam Questions and
Answers |100% Correct| 2024/2025
Latest Version
Describe the main responsibility of a clinical investigator in a clinical trial.
The primary responsibility of a clinical investigator is to protect the rights, safety,...
SOCRA (Society of Clinical Research
Associates) Final Exam Questions and
Answers |100% Correct| 2024/2025
Latest Version
Describe the main responsibility of a clinical investigator in a clinical trial.
The primary responsibility of a clinical investigator is to protect the rights, safety, and welfare
of the trial subjects.
What is the purpose of informed consent in clinical research?
The purpose of informed consent is to ensure that subjects voluntarily agree to participate in a
trial after being fully informed of the risks, benefits, and other relevant details.
Who is responsible for ensuring that clinical trials comply with Good Clinical Practice (GCP)
guidelines?
The investigator, sponsor, and regulatory authorities are responsible for ensuring that clinical
trials comply with GCP guidelines.
Explain the role of an Institutional Review Board (IRB) in clinical research.
An IRB is responsible for protecting the rights, safety, and welfare of research participants by
reviewing and approving clinical trial protocols.
When is it necessary to submit an amendment to the clinical trial protocol?
1
, An amendment must be submitted to the IRB and approved before any changes to the
protocol are implemented.
Define the term "adverse event" in the context of clinical trials.
An adverse event is any unintended or undesirable effect experienced by a participant during
a clinical trial, whether or not it is related to the investigational product.
What is the primary goal of a Phase I clinical trial?
The primary goal of a Phase I clinical trial is to evaluate the safety, tolerability, and
pharmacokinetics of an investigational product in a small group of healthy volunteers or patients.
How are subjects assigned to different treatment groups in a randomized clinical trial?
Subjects are assigned to treatment groups using a randomization process to eliminate bias and
ensure that each participant has an equal chance of receiving any treatment.
What is the purpose of a double-blind study design?
The purpose of a double-blind study is to reduce bias by ensuring that neither the investigator
nor the participant knows which treatment the participant is receiving.
Describe the role of a Clinical Research Associate (CRA) in a clinical trial.
A CRA monitors the progress of the trial, ensuring compliance with the protocol, regulatory
requirements, and GCP guidelines, and reports findings to the sponsor.
2
, How should deviations from the approved protocol be handled in a clinical trial?
Significant protocol deviations must be reported to the IRB, sponsor, and regulatory
authorities, depending on the severity and impact on the trial.
What is the significance of an investigational new drug (IND) application?
An IND application is submitted to the FDA to request authorization to begin clinical trials of
a new drug or biologic in humans.
What is the primary purpose of monitoring a clinical trial?
The primary purpose of monitoring a clinical trial is to ensure the integrity of the data and the
safety of the participants.
Explain the role of a Data Safety Monitoring Board (DSMB).
A DSMB is responsible for periodically reviewing the safety and efficacy data during a
clinical trial and recommending whether the trial should continue, be modified, or be terminated.
When should a clinical trial be registered in a public database, such as ClinicalTrials.gov?
A clinical trial should be registered before enrolling the first participant.
What is a source document in the context of clinical trials?
Source documents are original records, such as medical records and lab reports, that provide
evidence to support the data collected during a clinical trial.
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