Novice Tmf University Certification Quiz

24 Questions | By LMKCR | Updated: Mar 20, 2022 | Attempts: 175

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Novice Tmf University Certification Quiz - 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