Database Design

SCiAN’s uses the following documents for database design:

• Database Configuration: a specifications document developed to communicate the database structure (forms, visits, schedule of assessments, etc.) and edit checks required by the Sponsor
• Data Validation Plan: a document that defines the validation rules at the eCRF form and variable level.
• Data Management Plan: a document that defines the extent and scope of data management activities by all groups involved in clinical data management
• Protocol