Matthew Jones - Chair DIGIT Committee
The EMA guidance in relation to TMF (Paper and Electronic) is unfortunately still in draft and many of us had provided comments as such that it is ambiguous as to where the validation documentation resides.
In a recent EMA IWG I attended we discussed where validation documentation should be for eSource systems as a whole, and as long as there is adequate linkages back to the validation documentation for the exact version of the eTMF in place they stated that was sufficient. However, if I understand correctly, in your case if you choose to retain the validation documentation on behalf of the sponsor and provide in the event of an inspection,this should also be documented in contractual agreements defining what documentation, the timings of it's provision and even when the contract is complete how those documents can be accessed during an inspection. Business continuity plans in case of disaster/ insolvency etc, also need to be considered.
The inspectors during the meeting discussed with us how its very difficult for them to have direct access to this information, and they consider that if a CRO retains these, that it still comes under the essential documents required for study reconstruction, and therefore, must be treated as such.
I hope this helps a little, and please let us know if you have further questions