Novice Tmf University Certification Quiz
- 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
Questions: 10 | Attempts: 45394 | Last updated: Oct 9, 2020
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