DMR Support

This topic describes DMR Support within Migration Vault, which is automatically enabled for all Migration projects.

Migration Vault provides Data Management Review (DMR) support to assist in workflows and ensure migrated studies retain the same DMR attributes as the Legacy EDC System. This is accomplished by applying DMR attributes to objects in the Attributes CSV File and implementing checks on review data.

Applying Attributes

DMR attributes are applied in the Attributes CSV File at the Casebook, Form, and Item levels when the following conditions are met:

  • The Attributes file is present in the Load
  • Values in the DMR column equal “true”
  • Identifying information is present for each attribute (for example, Casebook, Form, Item)

In CDMS, the action of applying the DMR attribute is recorded in the Audit Trail of the migrated object. Source Data Verification (SDV) and DMR attributes can both be applied to the same object (for example, Form).

Migration Vault does not directly apply DMR attributes at the Event, Event Date, or Item Group levels, nor for Visit Methods or objects created during the Repair process.

Form Submission

Migration Vault will automatically submit a Form to apply its DMR attribute if the Attributes CSV File is present in the Load and the Form’s DMR attribute is set to “true”. This submission occurs regardless of whether the Form has the SDV attribute applied to it or not.

If the Form has the SDV attribute set to “true” but the DMR attribute is NULL, the Form will still be submitted to enable the application of SDV. This ensures that both DMR and SDV attributes are applied during the migration process.

Errors

Errors related to the Attributes CSV File may occur in the following situations:

  • The DMR column is absent
  • The DMR column contains a value other than “true”
  • The DMR column contains both a parent Subject and its child Event with “true” values

Checking Review Data

Migration Vault ensures that your Study Design, including DMR data, is properly configured before migration.

Corresponding review state records are created across all sites for each Item, Event, _and child _Event. To facilitate the record creating process, your target study must include a Review Plan with the plan type set to “DMR.”

Review state records are not created when Reviews are disabled in CDMS.

Duplicates

To prevent duplicate review state records, Migration Vault verifies that studies do not contain a Review Plan Assignment. If a Review Plan Assignment is configured for a Study, an error occurs, and the user must delete the record in order to proceed with the migration.

Learn more about Migrating Data Attributes