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TMF_Institut Léonard de Vinci_26Mar2019

A clinical research setting with a focus on Trial Master File (TMF) documents, including images of essential trial documents and a clinical research associate reviewing them, modern office background, bright and engaging colors.

TMF Essentials Quiz

Test your knowledge about the essential trial documents and the role of Clinical Research Associates (CRAs) in the Trial Master File (TMF) process. This quiz is designed for professionals and students in the clinical research field to assess their understanding of regulatory requirements and best practices.

6 thought-provoking questions
Immediate feedback on your answers
Perfect for enhancing your knowledge

6 Questions2 MinutesCreated by AssessingData24

Essential trial documents are stored in

Trial Management Folder (TMF)

Trial Master File (TMF)

Trial Master Folder (TMF)

Investigator Site File (ISF)

I am not sure / I don't know

FDA1572 is

Always required for phase III trials in Europe

Required only for IND trials

I am not sure / I don't know

Role of a CRA in TMF creation

No role at all, this task is not assigned to a CRA

In some cases CRA might review TMF

CRA is responsible for the document collection

CRA is responsible for the quality of the documents he has received from the site

I am not sure / I don't know

Sharing of a unique electronic ID used in e-documents completion is

Violation of GCP

Failure to comply with "ALCOA" requirement

"L" of "ALCOA" is not respected, produced e-document aren't Legible

"O" of "ALCOA" is not respected, produced e-document aren't Original

Violation of CFR Title 21 Part 11

I am not sure / I don't know

Should an IMV follo-up letter be filed in TMF

Yes

I am not sure / I don't know

Copy of personal patient's health insurance certificate should be filed in TMF

Yes

I am not sure / I don't know

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