Documentation covering validation of REDCap Audit Trail functionality, including signature retention

Policies on System Validation & System Lifecycle and Change Management

System validation - conducting and documenting individual feature tests that verify the system's core functionality is operating as expected

Documentation covering installation of system and verification process to show correct functioning of installation

Documentation covering outputs from system validation process

Documents covering Records Management and Retention

Documentation covering long-term record management

Documentation covering validation of record locking

Documentation covering project-specific record locking procedures

Project-level access management (including study role definitions and termination procedures) and any procedures related to adding or removing users

E-consent framework has been implemented with appropriate workflows documented

E-signatures and Record Locking functionality has been implemented with appropriate workflows documented

Documentation/records covering the education, training and experience of individuals using REDCap at external study sites.

Documentation that study staff have been trained on study processes (e.g. completion of Study Site Training Log)