Signature

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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.

An electronic signature applies to the entity to which it is attached (typically a form). The signature covers all clinical data in that entity at the time of the signing, including all clinical data in any subentities. Thus, a signature on a form includes all clinical data at the form, item group, and item levels.

For the purpose of this definition, clinical data includes all attributes and element content except for TransactionType attributes, Signature elements, and AuditRecord elements.

Note: A Signature applies to data at a particular point in time. A Signature cannot be modified. However, new signatures can be applied when clinical data changes.

Note: A Signature applies to the entire contents of the entity, not just the content that is mentioned in the current ODM element. A Signature applies to (static) content, not to a change in content.

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.