My experience is not that the MHRA hate file notes but that they are often not used in the way that you describe. I think if they truly describe the circumstances of an event on the trial or explain an anomaly in the Trial Master File, that seems a reasonable reason for creating a file note. Having said that, if a trail of emails provides the chronology of a discussion and they also contain a final decision reached, there would be no need for a file note as this is just duplicating the information recorded in the emails. In those circumstances, I would personally recommend NOT creating an additional document but rather group the related emails together (physically for a paper TMF or by metadata for an eTMF) so that the electronic discussion can be followed more easily.

Where I've seen file notes over-used is as "placeholders" to describe an alternative location for a document. For example, a decision has been made to file Regulatory Approval documents in the same section of the TMF as Ethics Approval. So in every country file of a TMF we see a file note to say "The Regulatory Approval document is located in section 4". It would be preferable to simply identify the filing location in a TMF Plan rather than use multiple file notes. This also happens when studies are outsourced and the sponsor files lots of file notes which just say "Document filed by CRO"..... add this information to your TMF Plan and the need for file notes becomes redundant as an inspector will understand from the TMF Plan which documents are filed by whom and where.

Eldin.