In our current eTMFs we also file documents that are the 'drafts and tracked changes' before a document becomes final, e.g CRFs, Protocol, PILs, CFs and others.

I understand that it is important to show that there has been a robust process in place during the drafting and review of the documents in question, but I cannot find anything officially that tells us that we must save these in our TMFs. In the past I have worked with ISO auditors and they were adamant that these documents also form part of the history of the trial and serve as important decision-making documents. Other auditors were not of the same opinion.

Does anyone have any advice as to what is considered good working practice in this area? any experience with the MHRA having commented on this during an inspection?

Thanks

Joanna