The Novice TMF University Certification Quiz assesses understanding of the Trial Master File (TMF) in clinical research. It covers documentation evaluation, compliance with GCP, and the benefits of electronic over paper TMF. Ideal for beginners seeking to enhance their clinical research skills.
FDA
MHRA
DEA
A and B
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True
False
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Following Good Clinical Practice (GCP)
Relying solely on ICH GCP Essential Document List
Understanding the regulatory environment of the governing authority
A and C
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The conduct of trial
The quality of the data produced
Compliance with Good Clinical Practice (GCP) and applicable regulations
All of the above
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True
False
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True
False
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Nothing. The document is filed as-is.
The document is returned to the submitter to make corrections.
Document Management fixes the error and files the document.
None of the above.
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Day one
When a site is initiated
When the study closes
When you receive notification of an inspection
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True
False
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True
False
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True
False
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True
False
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True
False
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Regulatory
Quality Management
CRO
All of the above
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True
False
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Storyboard
Protocol
ICH GCP Section 8
All of the above
None of the above
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Prospective QC
Retrospective QC
Oversight QC
A and C
All types are equally preferred.
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True
False
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True
False
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Volunteer information.
Never ask the inspector to clarify their questions.
Only answer questions specifically related to your role.
B and C
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True
False
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Content QC
Document (non-content) QC
Both A and B
None of the above
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Study Team Training
Screening and Enrollment Log
Clinical Study Report
A and B
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Quiz Review Timeline (Updated): Mar 20, 2023 +
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