Many organizations use outside systems to collect clinical data, and then assemble subject case report forms (CRFs) and datasets. Using the CRF and dataset import feature, users can quickly and easily file all final subject CRFs and datasets 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 RIM Submissions and RIM Submissions Publishing Vaults.
Granting Permissions
To import CRFs and datasets, a user must have at least read-only access to the Clinical Studies listing (generally through Admin > Business Admin) and Create Document permission on the document types, subtypes, and classifications selected for CRFs and datasets.
To import a new version of an existing CRF or dataset, a user must have Edit Document permission on Approved state documents in the Batch Import lifecycle.
How to Enable Batch Import
To enable the Import CRFs action:
- Navigate to Admin > Settings > Application Settings.
- Select the checkbox for Allow batch import of CRFs.
- Select a document type, subtype, or classification to apply to imported CRFs.
To enable the Import Datasets action:
- Navigate to Admin > Settings > Application Settings.
- Select the checkbox for Allow batch import of datasets.
- Select a document type, subtype, or classification to apply to imported datasets.
Once you enable Batch Import settings, you cannot disable them.
Batch Import Configuration
For CRF and dataset import to work correctly, you must complete the following configurations:
- Assign the Batch Import lifecycle to the CRF and dataset document types. Vault automatically creates and activates this lifecycle after enablement. The lifecycle has a simple configuration with a single state (Approved), no workflows, and no expiration. Imported documents must use this lifecycle.
- Ensure that the required fields (Clinical Study, Site) are on the CRF and dataset document types.
About Required Fields & Batch Import
When enabling CRF and dataset imports, verify that there are no required fields which apply to the selected CRF and dataset document types that do not have default values. Vault cannot populate document fields during imports unless they have default values, so required fields can prevent Vault from successfully creating documents.
About Approved State
By default, the Batch 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.