Novice Tmf University Certification Quiz

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| By LMKCR

LMKCR

Community Contributor

Quizzes Created: 1 | Total Attempts: 207

Questions: 24 | Attempts: 208 | Updated: Mar 20, 2023

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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
Correct Answer
D. All of the above

Explanation
Slide – 12-14

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2.

The ICH GCP Section 8 list of essential documents includes all expected documentation for the TMF.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Slide – 20

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3.

Reference models do not require any customization prior to use.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Slide – 48

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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
Correct Answer
B. False

Explanation
Slide – 52

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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
Correct Answer
D. All of the above

Explanation
Slide – 16

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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
Correct Answer
A. Regulatory

Explanation
Slide – 35

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7.

Which of the following regulatory agencies may inspect a TMF?
- A.
  
  FDA
- B.
  
  MHRA
- C.
  
  DEA
- D.
  
  A and B
Correct Answer
D. A and B

Explanation
Slide – 49

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8.

Sponsors may take responsibility for investigator documents.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Slide – 63

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9.

A majority of TMF documents come from the site.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Slide – 11

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10.

A protocol amendment is an example of a study milestone.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Slide – 14

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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
Correct Answer
A. Study Team Training

Explanation
Slide – 22, 26, 28

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12.

All Functional Lines are responsible and accountable for the content within the TMF.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Slide – 42

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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
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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14.

A scanned document image may be altered to increase legibility.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Slide – 27

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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.
Correct Answer
B. The document is returned to the submitter to make corrections.

Explanation
Slide – 34

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16.

TMF QC metrics can be used to assess TMF health.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Slide – 44

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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
Correct Answer
A. Day one

Explanation
Slide – 16

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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
Correct Answer
D. A and C

Explanation
Slide – 17 and 19

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19.

Criminal fines and penalties could be the consequence of TMF inspection findings in an FDA inspection.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Slide – 26

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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
Correct Answer
C. Only answer questions specifically related to your role.

Explanation
Slide – 43 and 45

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21.

Creating a TMF inventory is the same performing a TMF QC.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Slide – 14

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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
Correct Answer
D. All of the above

Explanation
Slide – 26

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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.
Correct Answer
D. A and C

Explanation
Slide – 31-33

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24.

The completed QC Tracker should be filed in the TMF as evidence of TMF QC.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Slide – 48

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Current Version
Mar 20, 2023

Quiz Edited by
ProProfs Editorial Team
Jan 06, 2017

Quiz Created by
LMKCR

Novice Tmf University Certification Quiz

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

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

Reference models do not require any customization prior to use.

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.

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

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

Which of the following regulatory agencies may inspect a TMF?

Sponsors may take responsibility for investigator documents.

A majority of TMF documents come from the site.

A protocol amendment is an example of a study milestone.

Common document(s) expected during study startup include:

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

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

A scanned document image may be altered to increase legibility.

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

TMF QC metrics can be used to assess TMF health.

When does inspection readiness start?

Being inspection ready means:

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

During a regulatory inspection, you should:

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

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

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

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