Sections in This Article
About Imported Cases
When you import a Case using E2B Case Migration, the resulting Case is an Imported Case.
An Imported Case is a special type of Case, which is reserved for previously processed and migrated Cases. Most case processing actions are permanently disabled on Imported Cases, including generating E2B transmissions. However, you can create and process a Follow-Up Case from an Imported Case.
The following table summarized which reports you can generate with an Imported Case:
| Report Format | Support for Imported Case? |
|---|---|
| E2B | No |
| CIOMS I | Yes |
| FDA 3500A | Yes |
| Aggregate Reports (DSUR, PADER, PBRER, PSUR) | Yes |
E2B Case Migration
If you have an E2B export of an external case, you can import a Vault Safety Case directly from the E2B file. You can import a Case from both E2B(R2) and (R3) files. However, we strongly recommend that you use an E2B(R3) file when available.
Enable E2B Case Migration
An administrator must configure a User Action on the AER Document Lifecycle to allow the Create Imported Case from E2B action. Define User Actions for Document States provides more information.
Migrate a Case from an E2B File
Once an administrator has enabled E2B Case migration, you can migrate E2B Cases.
Note We recommend that you contact Veeva Managed Services for assistance with migrating Cases from E2B files.
- Go to the Library tab.
- From the menu bar, select
. The Create Document window appears.
If you do not see the Create button, you do not have permission to upload documents. - On the Create Document window, select Upload > Continue.
- On the Upload Files (Step 1) page, drag and drop the E2B file into the blue area or select Choose to browse for the files on your device.
- Select Classify documents now, and then under Choose document type select Case › Source › Adverse Event Report.
- Select Next.
- On the Upload Files (Step 2) page, select the Organization.
- Select Save.
- Expand the All Actions (
) menu, and then select Create Imported Case from E2B.
This option may have a different label, depending on how your administrator configured the User Action.
Result
The system creates an Imported Case from the E2B file and maps the Study and Product to appropriate records in the Vault Safety admin library, if they are available. E2B Case Import Data Mapping provides more information.
(Non-E2B) Vault Loader Migration
As an alternative to migrating cases from E2B, you can use Vault Loader to bulk migrate Imported Cases. Vault Online Help provides instructions on using Vault Loader to migrate records. Contact Veeva Managed Services for assistance with importing Cases using Vault Loader.
