TMF_Institut Léonard de Vinci_26Mar2019
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
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
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