Many organizations use Medidata Rave™ EDC or other systems to collect clinical data and assemble subject case report forms (CRFs). Using the CRF import feature, users can quickly and easily file all final subject CRFs for a study into Vault. Vault automatically assigns the imported documents to the correct study and site, and sets them to Approved status and major version 1.0.
Note: This feature is only available on Clinical Operations eTMF Vaults.
How to Enable CRF Import
To enable the Import CRF action, navigate to Admin > Settings > Application Settings and select the checkbox for Enable CRF Import. Select a document type (Final CRF or another) to apply to imported CRF files. Once the feature is enabled, it cannot be disabled.
When you enable this feature, Vault automatically adds and activates the following standard configuration elements:
- Final CRF is the document type that Vault applies automatically to imported case report forms. When enabling, you can choose to use this document type, or another type. If using another type, you must assign it to the CRF Import lifecycle.
- CRF Import lifecycle has a simple configuration with a single state (Approved), no workflows, and no expiration. Imported documents must use this lifecycle.
None of these configuration elements require modification to make CRF importing possible.
Required User Permissions
To import CRFs, a user must have at least read-only access to the Studies listing (generally through Admin > Business Admin) and Create Document permission on the selected CRF document type. To import a new version of an existing CRF, a user must have Edit Document permission on Approved state documents in the CRF Import lifecycle. When configuring the feature, you should verify that users who will be importing CRFs have the correct document type- and document-level permissions.
Required Fields & CRF Import
When enabling CRF imports, verify that there are no required fields which apply to the selected document type that do not have default values. Vault cannot populate document fields during CRF imports unless they have default values, so required fields can prevent Vault from successfully creating documents.
Also verify that the selected document type includes the Study and Site fields, which are necessary for CRF imports to succeed.
By default, the CRF Import lifecycle only has a single state: Approved. This state is assigned as the Starting State for the lifecycle. Vault does not automatically assign a Steady State, but you can modify this configuration to make Approved the Steady State.
You can complete all steps in this article with the standard Business Admin, System Admin or Vault Owner profile.
If your Vault uses custom security profiles, your profile must grant the following permissions:
|Security Profile||Settings: General Configuration: Edit||
Ability to enable features in General Settings
|Security Profile||Configuration: Document Fields: Edit||
Ability to edit existing document fields