Do you all file your financial documents (i.e. Financial agreement with investigator(s), payments made to investigator sites(s), financial agreements with vendors) in the TMF?
The TMF Reference Model includes different artifacts for financial documents, but I had received different opinions that it is not good practice to file the financial documents in the TMF and make them visible to an auditor.
Filing in the TMF and making available to an auditor/inspector are not necessarily the same thing. In the TMFs I have been responsible for in the past, we have been able to flag these documents as financially sensitive and not make them available out of the box to an inspector. [And by the way there are probably many other people who should not see them.]
We were also able to change this on the fly if the inspector demanded access (although I never heard of them happening).
Most of my clients agreed that their position was not to provide access unless access was specifically requested. But I would say it’s a good practice to include in the TMF if your technology supports how you want to handle them.
We file the contracts and budgets for our sites as well as the vendor contracts. At the end of the study we file a report from the system we use for managing payments, but nothing during study conduct.