Body:
| (UserRef, LocationRef, SignatureRef, DateTimeStamp,CryptoBindingManifest? Deprecated) |
Attributes:
| ID | ID | (optional) | If a Signature element is contained within a Signatures element, the ID attribute is required. |
Contained in:
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.
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Note: The practice of initialing and dating changes on paper forms is a way of maintaining an audit trail. It should not be confused with 21 CFR Part 11 electronic signatures (Signature elements).
Note: Contrast with AuditRecord, and ds:Signature.Note: the CryptobindingManifest element has been deprecated.
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