Novice Tmf University Certification Quiz

24 Questions | Total Attempts: 100

SettingsSettingsSettings
Please wait...
Novice Tmf University Certification Quiz


Questions and Answers
  • 1. 
    The TMF is a collection of documentation that enable the following to be evaluated:
    • A. 

      The conduct of trial

    • B. 

      The quality of the data produced

    • C. 

      Compliance with Good Clinical Practice (GCP) and applicable regulations

    • D. 

      All of the above

  • 2. 
    The ICH GCP Section 8 list of essential documents includes all expected documentation for the TMF.
    • A. 

      True

    • B. 

      False

  • 3. 
    Reference models do not require any customization prior to use.
    • A. 

      True

    • B. 

      False

  • 4. 
    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.  
    • A. 

      True

    • B. 

      False

  • 5. 
    Advantages to utilizing an electronic TMF over a paper TMF include: 
    • A. 

      Centralized in one location

    • B. 

      Robust metrics and reporting capabilities

    • C. 

      Provides audit trails

    • D. 

      All of the above

  • 6. 
    Which of the following zones is/are included in the TMF Reference Model?
    • A. 

      Regulatory

    • B. 

      Quality Management

    • C. 

      CRO

    • D. 

      All of the above

  • 7. 
    Which of the following regulatory agencies may inspect a TMF?
    • A. 

      FDA

    • B. 

      MHRA

    • C. 

      DEA

    • D. 

      A and B

  • 8. 
    Sponsors may take responsibility for investigator documents.
    • A. 

      True

    • B. 

      False

  • 9. 
    A majority of TMF documents come from the site.
    • A. 

      True

    • B. 

      False

  • 10. 
    A protocol amendment is an example of a study milestone.
    • A. 

      True

    • B. 

      False

  • 11. 
    Common document(s) expected during study startup include:
    • A. 

      Study Team Training

    • B. 

      Screening and Enrollment Log

    • C. 

      Clinical Study Report

    • D. 

      A and B

  • 12. 
    All Functional Lines are responsible and accountable for the content within the TMF.
    • A. 

      True

    • B. 

      False

  • 13. 
    Which type(s) of QC assess whether a document is meaningful and relevant to the study?
    • A. 

      Content QC

    • B. 

      Document (non-content) QC

    • C. 

      Both A and B

    • D. 

      None of the above

  • 14. 
    A scanned document image may be altered to increase legibility.
    • A. 

      True

    • B. 

      False

  • 15. 
    What happens when Document Management identifies a QC issue with a document?
    • A. 

      Nothing. The document is filed as-is.

    • B. 

      The document is returned to the submitter to make corrections.

    • C. 

      Document Management fixes the error and files the document.

    • D. 

      None of the above.

  • 16. 
    TMF QC metrics can be used to assess TMF health.
    • A. 

      True

    • B. 

      False

  • 17. 
    When does inspection readiness start?
    • A. 

      Day one

    • B. 

      When a site is initiated

    • C. 

      When the study closes

    • D. 

      When you receive notification of an inspection

  • 18. 
    Being inspection ready means:
    • A. 

      Following Good Clinical Practice (GCP)

    • B. 

      Relying solely on ICH GCP Essential Document List

    • C. 

      Understanding the regulatory environment of the governing authority

    • D. 

      A and C

  • 19. 
    Criminal fines and penalties could be the consequence of TMF inspection findings in an FDA inspection.
    • A. 

      True

    • B. 

      False

  • 20. 
    During a regulatory inspection, you should:
    • A. 

      Volunteer information.

    • B. 

      Never ask the inspector to clarify their questions.

    • C. 

      Only answer questions specifically related to your role.

    • D. 

      B and C

  • 21. 
    Creating a TMF inventory is the same performing a TMF QC.
    • A. 

      True

    • B. 

      False

  • 22. 
    To determine the study-specific requirements for a study, you may utilize:
    • A. 

      Storyboard

    • B. 

      Protocol

    • C. 

      ICH GCP Section 8

    • D. 

      All of the above

    • E. 

      None of the above

  • 23. 
    Which of the following is/are the preferred method(s) of TMF QC?
    • A. 

      Prospective QC

    • B. 

      Retrospective QC

    • C. 

      Oversight QC

    • D. 

      A and C

    • E. 

      All types are equally preferred.

  • 24. 
    The completed QC Tracker should be filed in the TMF as evidence of TMF QC.
    • A. 

      True

    • B. 

      False