CCRP (Society of Clinical Research
Associates) SOCRA Exam Correctly
Solved Exam *Q&A* |Verified Study Set|
2024/2025
Describe the primary objective of Good Clinical Practice (GCP).
The primary objective of GCP is to ensure the protection of human subjects' rights, safety,
and well-being,...
CCRP (Society of Clinical Research
Associates) SOCRA Exam Correctly
Solved Exam *Q&A* |Verified Study Set|
2024/2025
Describe the primary objective of Good Clinical Practice (GCP).
The primary objective of GCP is to ensure the protection of human subjects' rights, safety,
and well-being, as well as to ensure the integrity and accuracy of clinical trial data.
Explain what a clinical trial protocol is and its significance in a research study.
A clinical trial protocol is a document that describes the objectives, design, methodology,
statistical considerations, and organization of a trial, ensuring consistency and compliance across
study sites.
What is the role of an Institutional Review Board (IRB) in clinical research?
An IRB reviews and approves clinical research studies to ensure they are ethically conducted
and that participants' rights and safety are protected.
What is the responsibility of a clinical research coordinator (CRC) in a trial?
The CRC manages day-to-day trial operations, such as participant recruitment, informed
consent, data collection, and adherence to the trial protocol.
1
, Define informed consent in clinical research.
Informed consent is a process by which a participant voluntarily confirms their willingness
to participate in a study after being informed of all relevant aspects of the trial, including risks
and benefits.
Who is responsible for reporting serious adverse events (SAEs) in a clinical trial?
The investigator is responsible for reporting SAEs to the sponsor, IRB, and regulatory
authorities in accordance with regulatory timelines.
Describe the purpose of a monitoring visit in clinical research.
A monitoring visit ensures the trial is conducted in compliance with the protocol, GCP, and
applicable regulations, and verifies the accuracy and completeness of collected data.
When is it necessary to amend a clinical trial protocol?
A protocol amendment is required when there are significant changes to the study design,
objectives, methodology, or safety considerations.
What is an investigational new drug (IND) application?
An IND application is submitted to the FDA to obtain authorization to begin clinical trials of
a new drug or biologic in humans.
What should be included in a case report form (CRF)?
2
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