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: If the Base directory path for gateway folders common profile switch is specified, then the Base directory path can be \\10.100.80.100\Gatewaysharedfolder\. The Out folder needs to be specified with the sub-folder path, such as eVAERS\OUT. Interchange services create folders in the <Base folder path>\<Abbreviated Enterprise name >\<Sub folder path> format. If the folder name created by the Interchange services is not required to insert the Abbreviated name of the Enterprise between the base directory path and the sub folder path, then the Interchange service to exclude Enterprise abbreviated name for the folder creation parameter in the EDI tab of Reporting Destination code list must be set. If the Base directory path for gateway folders common profile switch is not specified, then the Out folder needs to be specified with an absolute path such as \\10.100.80.100\Gatewaysharedfolder\eVAERS\OUT. Thus, the Interchange services create folders using the folder structure provided in the Sub folder path.
• File Name: Include appropriate format such CBER_###########.xml
• Method: E2B EDI gateway

Report tab

Check the Apply EMA Special Rules checkbox to apply EMA special instruction rules for cases that have at least one Reporter’s Country that belongs to the European Union.