eTMF
Electronic Trial Master File
True or False: The FDA uses your company's EDL during every inspection
What is False
The Purpose of an EDL
What is to regularly review checklist of required documents to identify anything missing prior to inspection
Define eTMF
What is: Electronic repository used to store trial documents
What is Expected Document List (EDL)?
What is a tool that helps study teams track which documents are expected to be filed and whether they have been filed
Double Jeopardy!
True or False: Finding missing documents before an inspection is better than discovering them during an inspection
What is true?