Novice Tmf University Certification Quiz

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Quizzes Created: 1 | Total Attempts: 218
| Attempts: 218
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  • 1/24 Questions

    Advantages to utilizing an electronic TMF over a paper TMF include: 

    • Centralized in one location
    • Robust metrics and reporting capabilities
    • Provides audit trails
    • All of the above
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About This Quiz

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.

Novice Tmf University Certification Quiz - Quiz

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  • 2. 

    Which of the following regulatory agencies may inspect a TMF?

    • FDA

    • MHRA

    • DEA

    • A and B

    Correct Answer
    A. A and B
    Explanation
    Slide – 49

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  • 3. 

    TMF QC metrics can be used to assess TMF health.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Slide – 44

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  • 4. 

    Being inspection ready means:

    • Following Good Clinical Practice (GCP)

    • Relying solely on ICH GCP Essential Document List

    • Understanding the regulatory environment of the governing authority

    • A and C

    Correct Answer
    A. A and C
    Explanation
    Slide – 17 and 19

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  • 5. 

    The TMF is a collection of documentation that enable the following to be evaluated:

    • The conduct of trial

    • The quality of the data produced

    • Compliance with Good Clinical Practice (GCP) and applicable regulations

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    Slide – 12-14

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  • 6. 

    The governing regulatory agency may inspect the sponsor, CRO, or clinical trial site to ensure compliance with the principles of Good Clinical Practice (GCP) only after a trial has been completed.  

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Slide – 52

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  • 7. 

    All Functional Lines are responsible and accountable for the content within the TMF.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Slide – 42

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  • 8. 

    What happens when Document Management identifies a QC issue with a document?

    • 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.

    Correct Answer
    A. The document is returned to the submitter to make corrections.
    Explanation
    Slide – 34

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  • 9. 

    When does inspection readiness start?

    • Day one

    • When a site is initiated

    • When the study closes

    • When you receive notification of an inspection

    Correct Answer
    A. Day one
    Explanation
    Slide – 16

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  • 10. 

    Reference models do not require any customization prior to use.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Slide – 48

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  • 11. 

    Criminal fines and penalties could be the consequence of TMF inspection findings in an FDA inspection.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Slide – 26

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  • 12. 

    Creating a TMF inventory is the same performing a TMF QC.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Slide – 14

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  • 13. 

    The ICH GCP Section 8 list of essential documents includes all expected documentation for the TMF.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Slide – 20

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  • 14. 

    Sponsors may take responsibility for investigator documents.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Slide – 63

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  • 15. 

    Which of the following zones is/are included in the TMF Reference Model?

    • Regulatory

    • Quality Management

    • CRO

    • All of the above

    Correct Answer
    A. Regulatory
    Explanation
    Slide – 35

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  • 16. 

    A protocol amendment is an example of a study milestone.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Slide – 14

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  • 17. 

    To determine the study-specific requirements for a study, you may utilize:

    • Storyboard

    • Protocol

    • ICH GCP Section 8

    • All of the above

    • None of the above

    Correct Answer
    A. All of the above
    Explanation
    Slide – 26

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  • 18. 

    Which of the following is/are the preferred method(s) of TMF QC?

    • Prospective QC

    • Retrospective QC

    • Oversight QC

    • A and C

    • All types are equally preferred.

    Correct Answer
    A. A and C
    Explanation
    Slide – 31-33

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  • 19. 

    The completed QC Tracker should be filed in the TMF as evidence of TMF QC.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Slide – 48

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  • 20. 

    A majority of TMF documents come from the site.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Slide – 11

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  • 21. 

    During a regulatory inspection, you should:

    • Volunteer information.

    • Never ask the inspector to clarify their questions.

    • Only answer questions specifically related to your role.

    • B and C

    Correct Answer
    A. Only answer questions specifically related to your role.
    Explanation
    Slide – 43 and 45

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  • 22. 

    A scanned document image may be altered to increase legibility.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Slide – 27

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  • 23. 

    Which type(s) of QC assess whether a document is meaningful and relevant to the study?

    • Content QC

    • Document (non-content) QC

    • Both A and B

    • None of the above

    Correct Answer
    A. Content QC
    Explanation
    Content QC assesses whether a document is meaningful and relevant to the study. This type of QC involves reviewing the content of the document to ensure it aligns with the study objectives and provides valuable information. Document (non-content) QC, on the other hand, focuses on assessing the technical aspects of the document, such as formatting, grammar, and adherence to guidelines. Therefore, the correct answer is Content QC.

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  • 24. 

    Common document(s) expected during study startup include:

    • Study Team Training

    • Screening and Enrollment Log

    • Clinical Study Report

    • A and B

    Correct Answer
    A. Study Team Training
    Explanation
    Slide – 22, 26, 28

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Quiz Review Timeline (Updated): Mar 20, 2023 +

Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.

  • Current Version
  • Mar 20, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Jan 06, 2017
    Quiz Created by
    LMKCR
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