An electronic signature applies to a collection of clinical data. This indicates that some user accepts legal responsibility for that data. See 21 CFR Part 11. The signature identifies the person signing, the location of signing, the signature meaning (via the referenced SignatureDef), the date and time of signing, and (in the case of a digital signature) an encrypted hash of the included data.
The Signature element provides a simple mechanism to state that the user accepts legal responsibility for that data. It should not be confused with an embedded XML-based electronic signature such as XML-Signature, which can be added through an extension ds:Signature element.
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