Novice Tmf University Certification Quiz

1. TMF QC metrics can be used to assess TMF health.

True

False

Slide – 44

Explanation

Slide – 44

2. 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

Slide – 17 and 19

Explanation

Slide – 17 and 19

3. 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

Slide – 16

Explanation

Slide – 16

4. Which of the following regulatory agencies may inspect a TMF?

FDA

MHRA

DEA

A and B

Slide – 49

Explanation

Slide – 49

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

Slide – 12-14

Explanation

Slide – 12-14

6. 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.

Slide – 34

Explanation

Slide – 34

7. 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

Slide – 52

Explanation

Slide – 52

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

True

False

Slide – 42

Explanation

Slide – 42

9. Reference models do not require any customization prior to use.

True

False

Slide – 48

Explanation

Slide – 48

10. When does inspection readiness start?

Day one

When a site is initiated

When the study closes

When you receive notification of an inspection

Slide – 16

Explanation

Slide – 16

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

True

False

Slide – 26

Explanation

Slide – 26

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

True

False

Slide – 14

Explanation

Slide – 14

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

True

False

Slide – 20

Explanation

Slide – 20

14. Sponsors may take responsibility for investigator documents.

True

False

Slide – 63

Explanation

Slide – 63

15. A protocol amendment is an example of a study milestone.

True

False

Slide – 14

Explanation

Slide – 14

16. 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

Slide – 26

Explanation

Slide – 26

17. 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.

Slide – 31-33

Explanation

Slide – 31-33

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

Regulatory

Quality Management

CRO

All of the above

Slide – 35

Explanation

Slide – 35

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

True

False

Slide – 48

Explanation

Slide – 48

20. A majority of TMF documents come from the site.

True

False

Slide – 11

Explanation

Slide – 11

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

Slide – 43 and 45

Explanation

Slide – 43 and 45

22. A scanned document image may be altered to increase legibility.

True

False

Slide – 27

Explanation

Slide – 27

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

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.

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.

24. Common document(s) expected during study startup include:

Study Team Training

Screening and Enrollment Log

Clinical Study Report

A and B

Slide – 22, 26, 28

Explanation

Slide – 22, 26, 28