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Dear all,
at study start, we usually create a TMF Index from our documents, as well as documents from our vendors.
Does anybody has a recommendation how to make sure, that our vendors have listed every single document/record from their side in the TMF Index? Is it somehow possible to ensure that we do not miss a document/record?
As we do not know exactly their internal processes and documents, it seems to be impossible.
Thank you very much in advance for your suggestions! -
Hi Sarah
It sounds like you are describing something that is usually included in the TMF Plan. This document describes the responsibilities of each party, including TMF documents that each third party is responsible for (amongst others). If you use an eTMF that includes idenrtof expected documents or placeholders, these would usually include documents provided by the vendor too. This should be discussed with the vendor prior to study start.
Kind regards
Eldin.
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