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Thanks Eldin. The types of databases I am referring to are Risk-Based Monitoring platform, Clinical Data Sharing Platform.
We have received documents from vendors password protected because their SOP requires it. We instruct our teams to remove any passwords before filing them.
We provide the clarification in the Filing Guidance within our Index to ensure users know which level to file certain documents. For example, Central IRB documents are filed at Country Level, Local IRB documents are filed at Site Level.
We try to avoid this as much as possible for the exact reason that Todd mentions above. We have had several meeting types that discuss multiple studies and we have recommended to those teams to break out into separate documents. If separate documents per study is not feasible, we would file the document in each of the study TMFs, but we do not de-identify.
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.
We decided that it was best practice to include a signature on our NTFs and we will look for that when we QC them. We have updated any NTF templates to include a signature line as well.
We file only the submission and acknowledgement correspondence in the eTMF. The SUSARs remain in the system they are generated in.
We do use DocuSign and you are correct Benjamin it must be the validated version. Currently we use it for distinct document types e.g. vendor contracts, but not everything. We have been promoting the use of the e-signature workflow within our eTMF, but that is only helpful if all the signatories have access to the eTMF.
Jackie