4 Set up Reporting Destinations
Here are the recommendations for creating the reporting destination to send eVAERS to the FDA.
Agency Information tab
Enter Name and address information as applicable.
CBER Technical specification recommends using CBER_VAERS as Agency Identifier.
Local Company Contact tab
Enter Name and address information of the Local Company Contact that is responsible for eVAERS submission.
The following data are required for eVAERS submission other than mandatory fields shown in UI:
- Sender Type
- Department
- Contact Name information
- Title
- First Name
- Last Name
- Address
- City
- State
- Postal Code
- Country
- Phone
- Fax
- Email Address
EDI Tab
- Agency Identifier: CBER_VAERS
- Message Profile: select CBER EVAERS V1.0 MESSAGE TEMPLATE (standard profile).
- ACK Profile: select ICH-ICSR V1.1 ACKNOWLEDGMENT TEMPLATE – FDA
- Transmit ICSR Attachments: Marked
- Attachment Classification: Mark one or more attachment classification that is required to be submitted along with eVAERS
- Allowed attachment file size (in MB): 15
- Allowed report size (in MB): 100
- Outgoing folder: Specify the outgoing folder location such as C:\ESM\CBER\OUT\
- File Name: Include appropriate format such
CBER_###########.xml - Method: E2B EDI gateway