Study Specific TMF Index

[Colleen Maude]

For those using an eTMF system: Do you require a study specific customization of your expected document list be done in your eTMF? If yes, what are the key steps?
If yes, is customization at all levels, study, country and site?
Do you extract and save the customization with the study TMF Plan?

If you do not create a study specific TMF index, why not?

[Richard Golden]

i assume you are talking about Expected Document Lists in Veeva Vault? We have a few templates but it’s impossible to create specific template for every single study. So it’s important to manipulate the EDL by designating what is required or not required. This manipulation takes place at all three levels. (Of course, we may upload documents into the library that are not reflected in the EDL, but those are few and far between)

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