Reply To: Financial Agreement in eTMF

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#2768
Irene Middendorf
Participant

Hello Ishita, Our company policy has always been not to file financial documentation in the eTMF. We utilize a separate database to store all contracts/budgets and as you mentioned above, document this location in the study specific TMF plans. If required, financially redacted documents are provided to auditors. This would also apply to overarching agreements that may span across multiple studies.