Under a vendor’s eTMF system, the CRO determines who are authorized users, so who is “responsible for the content of the electronic records” that are entered by site personnel?
The sponsor/CRO. The sponsor is ultimately responsible; however, if the CRO is determining the authorizations, she/he is responsible as well. The investigator is responsible for the collection of the original source data and signing off of each case report form that accurately reflects the original source data (from 2016). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
When a sponsor collects and maintains essential documents for a clinical TMF, are signed paper documents and electronic scans of signed documents equally acceptable?
The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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