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e-Signature

# Application
Last updated: 04/14/2026

Business definition of e-Signature — electronic signing of CRF, event, and subject records.

What it is

The Signature app provides electronic signing of study data at the CRF, event, and subject level. It supports regulatory-compliant signing workflows with credential confirmation, signed status tracking, and audit trail.

Who uses it

RoleTypical use
InvestigatorSign subject records and completed CRFs
CRC / Site staffSign data entry where protocol requires
Study AdministratorConfigure signing requirements and scope
MonitorReview signed status during monitoring

Key capabilities

  • Sign at subject level or individual form level
  • View-by-Subject and View-by-Form worklists
  • Credential re-entry at time of signing
  • Signed status tracking across the study
ApplicationE-SignatureSignature21 CFR Part 11
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