Reply To: Document Receive Date

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Eldin Rammell

I hear this question asked quite often and there are different perspectives. One is to think about what the process was before we started to use eTMF systems. It was very rare to capture the date that a document was received…. perhaps on a TMF Transmittal form but probably not for all documents. So why should we change our process just because we now have new technology?

On the other hand, if you have an SOP that states you file documents within a specific time period, it seems logical that you should have some means of demonstrating compliance. This could be achieved by capturing the receive date.

So there is no specific regulatory requirement or expectation for a receive date. You just need to consider how you will be able to demonstrate that your TMF is contemporaneous. If you can do this without capturing the receive date, that should be acceptable.