E2B Document Attachments and Literature References

Based on specified criteria, Vault attaches documents to E2B transmissions.

E2B Document Attachments and Literature References

Vault includes Case and Localized Case documents that meet specified criteria with E2B transmissions. Add a Case Attachment or Literature Document provides information on adding these documents to Cases. For Cases and Localized Cases linked to Literature Articles in your SafetyDocs Vault, Vault populates records for the related literature documents in the Documents section.

Vault handles attachment transmissions differently for E2B(R2) and (R3). The following list provides more information:

  • E2B(R2) Transmissions: For E2B(R2) formats, Vault encodes attachments and literature documents directly in the E2B file if the Literature Documents field value on the Transmission is Include. Vault adds all literature references to a single A.2.2 Literature Reference(s) block on the submission.
  • E2B(R3) Transmissions: For E2B(R3) formats, Vault encodes attachments and literature documents directly in the E2B file if the Literature Documents field value on the Transmission is Include. Vault adds each literature reference to a separate C.4.r.1 Literature Reference(s) block on the submission. E2B(R3) formats also support destination-specific document retransmission based on Transmission Profile configuration.
  • FDA E2B(R2) Transmissions: For FDA E2B(R2) gateway transmissions, Vault sends attachments separately after receiving an acknowledgment (ACK) acceptance from the health authority for the ICSR E2B transmission. Once sent, each attachment receives its own ACK.

You must verify that E2B transmission attachments are supported by the destination gateway and that file sizes do not exceed export limits. The following list provides links with more information on verification with various destination gateways:

Prerequisites

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

Document Attachments

To attach a document (A.1.8.1/C.1.6.1.r.2), the Vault document fields must be completed as follows:

  • The Case field must link to the Case for which the E2B is being generated.
  • The Organization field must link to the same Organization as the Case.
  • The document must be classified with the Case > Source > Attachment document type.
  • The Retransmit field must be set to Yes.
  • To populate the E2B Documents Held by Sender (A.1.8.2/C.1.6.1.r.1) data element, complete the Description and Description(continue) fields. In E2B(R3), attachment descriptions are always exported regardless of the Retransmit field value.
  • For Cases with over-the-counter (OTC) drugs, to attach OTC carton images to FDA E2B(R2) Transmissions being sent through an AS2 Connection, you must also set the Attachment Type field to FDA Carton Attachment.
  • The document must meet the Attachment Inclusion Control criteria.

Literature Attachments

To attach a literature reference document (A.2.2/C.4.r.1-2), the Vault document fields must be completed as follows:

  • The Case field must link to the Case for which the E2B is being generated.
  • The Organization field must link to the same Organization as the Case.
  • The document must be classified with any of the following document types:
    • Case > Source > Literature
    • Literature > Literature Article > Full-Text
    • Literature > Literature Article > Summary
  • To populate the E2B Literature Reference(s) (A.2.2/C.4.r.1) data element, complete the Reference field. References are always exported regardless of the Retransmit field value.
  • To export the document content to the Included Documents (C.4.r.2) data element, you must set the Retransmit field to Yes.
  • The document must meet the Literature Inclusion Control criteria.

Exclude Attachments and Literature Documents

To exclude attachments during Transmission creation, set the Attachments Documents and Literature Documents fields to Exclude as needed. Vault excludes all documents with Retransmit field values of No.

Destination-specific Documents

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 Submission or Distribution record.

Vault may include or exclude documents in initial or follow-up Case scenarios based on your Admin’s configuration of the associated Transmission Profile. This improves compliance when reporting to certain health authorities.

Destination-specific Attachment Types

Vault restricts the attachment of some documents to E2B reports based on the attachment type and the reporting destination. To see a document’s attachment type, view the Attachment Type field in the Document Information pane of the document. Vault-included attachment types are:

  • China Death Certificate
  • FDA Carton Attachment
  • PMDA JPPI

Admins can configure additional Attachment Types to meet business needs.

To include documents with a particular attachment type when reporting to a specific destination, your Admin must configure the applicable Transmission Profile.

Attachment Inclusion Control

When evaluating whether to include document contents in E2B reports, Vault evaluates the required document attachment criteria and the destination-specific attachment type. Additionally, 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 contents of the document have been encoded in the C.1.6.1.r.2 Included Documents data element of a previous Transmission for that Case to that reporting destination.

  • For previously encoded documents, Vault does not generate Destination Specific Document Inclusions records for the Transmission. In this scenarios, Vault populates the C.1.6.1.r.1 Documents Held by Sender data element only.
  • For documents that haven’t been encoded previously, whether because the Transmission is initial or the document is new on the follow-up Case, Vault generates Destination Specific Document Inclusions records for the Transmission. In this scenario, Vault populates both the C.1.6.1.r.1 and C.1.6.1.r.2 data elements.

If the Attachment Inclusion Control setting is No, Vault populates both the C.1.6.1.r.1 and C.1.6.1.r.2 data elements for all documents being retransmitted.

Literature Inclusion Control

When evaluating whether to include literature article contents in E2B reports, in addition to the required literature article attachment criteria and the destination-specific attachment type, 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 Included Documents data element of a previous Transmission for that Case to that reporting destination by checking the literature document.

  • For previously encoded literature articles, Vault does not generate Destination Specific Document Inclusions records for the Transmission. In this scenario, Vault populates the C.4.r.1 Literature Reference(s) data element only.
  • For literature articles that haven’t been encoded previously, whether because the Transmission is initial or the literature article is new on the follow-up Case, Vault generates Destination Specific Document Inclusions records for the Transmission. In this scenario, Vault populates both the C.4.r.1 and C.4.r.2 data elements.

If the Literature Inclusion Control setting is No, Vault populates both the C.4.r.1 and C.4.r.2 data elements for all literature articles being retransmitted.