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15 Terms
1
What is a trial protocol?
An essential document that provides a full description of the trial and all its procedures, outlining the rules, eligibility, and roles involved.
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2
Why are clinical trial protocols important?
They ensure ethical and scientific quality in trial design and implementation, facilitate proper data collection and patient safety.
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3
Who takes primary responsibility for the conduct of a trial?
The Chief Investigator.
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4
What are essential documents in a clinical trial?
Documents that aid in evaluating trial conduct, participant safety, and data quality.
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5
What should a good protocol include?
Clarity, operational feasibility, compliance with guidelines, and incorporation of expert opinion.
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6
What are the risks of a poorly written protocol?
Delays in timelines, misinterpretation by staff, jeopardized patient safety, and compromised data integrity.
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7
What approvals are needed before starting a clinical trial?
Approval from a regulatory body (e.g. MHRA) and ethical approval from a Research Ethics Committee (REC).
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8
What distinguishes substantial amendments from non-substantial amendments in protocol changes?
Substantial amendments significantly impact scientific value or safety, while non-substantial amendments do not.
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9
How should protocol deviations be managed?
They must be reported to the Sponsor to aid trial management and ensure adherence to the protocol.
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10
What is the importance of publishing clinical trial protocols?
It promotes transparency and allows for appraisal of the trial's design and conduct by various stakeholders.
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11
What are some key sections to include in a clinical trial protocol?
Introduction, trial design, aims and objectives, eligibility criteria, safety section, data management, and participant timeline.
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12
What is the primary document that guides the conduct of a clinical trial?
The trial protocol.
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13
What is ICH GCP?
International Council for Harmonisation Guideline for Good Clinical Practice, an international standard ensuring ethical and scientific quality in trials.
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14
What is patient and public involvement (PPI) in trial protocols?
The involvement of patients and the public in the trial design and conduct process.
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15
What is the purpose of a protocol review committee (PRC)?
To evaluate and provide feedback on the clinical trial protocol before approval.
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