Preparing the Extract Package

This topic describes what sponsors should include in their migration extracts and how we ingest data for migration.

To initiate the migration process, sponsors must provide Veeva with an extract package containing all required clinical data for a Study. This package typically includes:

• A CSV file for each Form Definition in the Study Schedule.
• A CSV file for all Events, or one file for each Event Type.
• A system CSV file containing all Queries.
• System CSV files for all Casebook statuses.

File Requirements

To use the Migrator, your data must meet the following requirements:

• Source data must be in UTF-8 encoded CSV format. Other file types are ignored.
• Each file must be smaller than 4GB. Files larger than that will result in an error.
• Data must contain the full object hierarchy, which is Site > Subject > Event Group > Event > Form > Item Group > Item. Objects with a partial hierarchy will not be migrated.

Processing the Extract

Veeva, or a third-party partner, uses the extract package to create input files for the EDC Migrator. One of these is a CSV file for all Queries and Query Messages, which is optional and only required if the sponsor chooses to migrate queries. The other is a CSV file for all Casebook statuses, such as Locked, Frozen, Signed, SDV, or DMR.

The Migrator ingests, parses, and migrates Events, Forms, and Items using the Event and Form CSV files. It processes queries using the Queries CSV file and applies statuses to the migrated objects using the Attributes CSV file.