If EMRs are used as source documents, how should source documents be kept at the research site?
Your EMR can be your source record, they do not need to be printed out by investigators and certified because they can be accessed if needed. If you do make certified copies of the medical records, monitors/auditors will want to at least spot check the completeness of these records at the source (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
If a sponsor develops an SOP policy; obtains a wet-ink signature on the SOP from the approvers; scans the signed document into an electronic system, PDFs the document, and stores the document electronically to allow staff accessibility, does the sponsor need to maintain the original wet-ink signed SOP/policy?
Can paper source documents be scanned, stored electronically, and originals can be shredded, or must all paper source documents be stored according to study storage requirements since they are the original source documents?
The summaries presented in our library are for informational purposes only, they are not for implementation in operations.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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