E2B Document Attachments and Literature References

When generating E2B transmissions, Vault includes Case and Localized Case documents, including attachments and literature references, that meet specified criteria. Vault includes documents with E2B(R2) and E2B(R3) files when:

  • Retransmit is set to Yes on the Document.
    • Vault excludes all Documents with Retransmit set to No.
  • The corresponding Attachment Documents or Literature Documents field is set to Include on the Transmission.
    • To exclude documents, set these fields to Exclude.
    • For E2B(R2) Transmission Document Types, Vault supports the Include and Exclude options on the Literature Documents field for FDA E2B(R2) files only.

If configured by your Admin, instead of using these criteria, Vault includes documents with E2B(R3) files based on the reporting destination.

Prerequisites

To use all of the features described on this page, your Admin must enable:

Include Attachments and Literature References With E2B Files

To include attachments or literature references with E2B files, classify documents as:

  • For attachments:
    • Case > Source > Attachment
  • For literature references:
    • Case > Source > Literature
    • Literature > Literature Article > Full-Text
    • Literature > Literature Article > Summary

Then, complete the Document fields on the Doc Info Pane as follows:

  • Case: Link to the Case for which you are generating the E2B file.
  • Organization: Match the Organization on the Case.
  • Retransmit: Enter Yes to export the attachment or literature reference content to the C.1.6.1.r.2 or C.4.r.2 data element of E2B(R3) files.
  • Description and Description(continue): You can enter attachment descriptions, which Vault exports as follows:
    • For E2B(R2) files, Vault exports descriptions to the A.1.8.2 data element for documents with Retransmit set to Yes.
    • For E2B(R3) files, Vault exports descriptions to the C.1.6.1.r.1 data element, regardless of the Retransmit value.
  • Reference: You can enter literature reference information, which Vault exports as follows:
    • For E2B(R2) files, Vault exports reference information to the A.2.2 data element, regardless of the Retransmit value.
    • For E2B(R3) files, Vault exports reference information to the C.4.r.1 data element, regardless of the Retransmit value.
  • Attachment Type: For Cases with over-the-counter (OTC) drugs, to attach OTC carton images to FDA E2B(R2) files being sent through an AS2 Connection, select FDA Carton Attachment.

In Vaults configured to attach documents to E2B(R3) files based on the reporting destination, documents must meet the Attachment Inclusion Control or Literature Inclusion Control criteria. With this configuration, Vault does not consider the Retransmit value.

Cases Linked to Literature Articles in SafetyDocs

For Cases linked to Literature Articles in SafetyDocs Vaults, when generating any E2B(R3) format other than PMDA E2B(R3), Vault populates the C.4.r.1 data element regardless of whether the document is attached to the Case. However, when generating PMDA E2B(R3) reports, Vault does not automatically attach Literature Articles, so you must attach all documents you want to include in that data element.

Destination-Specific Document Inclusion

For E2B(R3) generation, Vault offers granular control over attachment and literature reference inclusion based on reporting destination. Your Admin can configure Attachment Types that are specific to a single destination. For example, they can include Death Investigation Reports (DIRs) on Transmissions to the National Medical Products Administration (NMPA) for China domestic Cases and exclude them from Transmissions to all other destinations for that Case. In addition, for follow-up Transmissions to a destination, Vault sends document descriptions but excludes document contents, improving compliance.

If your Admin has configured the Inclusion Control settings described below on the Transmission Profile, when you run the Evaluate Reporting Obligations action on a Case or the Generate Local Reporting Details action on a Japan Localized Case, Vault generates a list of all of the documents included in the report for the destination. You can review the list in the Destination Specific Document Inclusions section of the applicable ICSR Transmission.

Attachment Inclusion

When determining whether to include an attachment, Vault evaluates the document setup and compares the Attachment Type on the Document to the Destination Specific Attachment Type on the Transmission Profile. Documents are candidates for attachment when:

  • The Attachment Types are an exact match.
  • The Attachment Type on the Document is blank. You can view a document’s attachment type in the Doc Info Pane of the document.

For documents that are candidates for inclusion, Vault references the Attachment Inclusion Control setting on the Transmission Profile for each destination. If the Attachment Inclusion Control setting is Yes, for each attached document, Vault checks if the document contents have been encoded in the C.1.6.1.r.2 data element of a previous Transmission for that Case to that reporting destination:

  • For documents that were sent as part of a previous Transmission, Vault does not reattach the document and includes only the attachment description.
  • For documents that are present for the first time at the time of submission, whether for an initial or follow-up Transmission, Vault both attaches the document and includes the description.

If the Attachment Inclusion Control setting is No or blank, Vault populates both the attachment contents and description for each document with Retransmit set to Yes and Attachment Documents set to Include on the Transmission.

Literature Reference Inclusion

When determining whether to include literature references, Vault evaluates the document setup. For literature articles that are candidates for inclusion, Vault references the Literature Inclusion Control setting on the Transmission Profile for each destination. If the Literature Inclusion Control setting is Yes, for each literature article, Vault checks if the contents of the literature article have been encoded in the C.4.r.2 data element of a previous Transmission for that Case to that reporting destination:

  • For literature articles that were sent as part of a previous Transmission, Vault does not reattach the document and includes only the reference information.
  • For literature articles that are present for the first time at the time of submission, whether for an initial or follow-up Transmission, Vault includes both the literature article contents and reference information.

If the Literature Inclusion Control setting is No or blank, Vault populates both literature article contents and reference information for all literature articles with Retransmit set to Yes and Literature Documents set to Include on the Transmission.

Document Mapping and Transmission

During E2B generation, Vault maps included documents as follows:

  • E2B(R3):
    • Attachments to the C.1.6 section
    • Literature references to the C.4.r section
  • E2B(R2):
    • Attachments to the A.1.8.1-2 section
    • Literature references to the A.2.2 section

Vault handles document transmissions for E2B(R3) and (R2) formats based on gateway rules:

  • E2B(R3): Encodes attachments and literature documents directly into the E2B file. Vault adds each literature reference to a separate C.4.r.1 block. E2B(R3) formats support destination-specific document retransmission.
  • FDA E2B(R2): Sends attachments separately after receiving an acknowledgment (ACK) acceptance from the health authority. Each attachment receives its own ACK. This feature works with FDA gateways, but not with configurable (custom) synchronous gateways.
  • All other E2B(R2): Encodes attachments and literature documents directly into the E2B file. Vault combines all literature references in a single A.2.2 block.

Gateway Supported Formats

You must verify that E2B transmission attachments are supported by the destination gateway and that file sizes do not exceed export limits. For more information on destination gateways, see:

Supported File Types

Vault supports the following file types for attachments and literature references:

  • Bitmap (BMP)
  • DICOM Medical Imaging File (DCM)
  • HyperText Markup Language (HTML, HTM)
    • Not accepted for FDA VAERS E2B(R3)
  • JPEG, JPG
  • Microsoft Excel Document (XLS, XLSX)
  • Microsoft Word Document (DOC, DOCX)
    • FDA VAERS E2B(R3) accepts DOC, but not DOCX
  • Portable Document Format (PDF)
  • Rich Text Format (RTF)
  • Text File Format (TXT)
  • Tagged Image File Format (TIF, TIFF)