# E2B Document Attachments and Literature References Vault includes _Case_ and _Localized Case_ documents that meet specified criteria, including export limits, 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][1] 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][2] 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: * International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) * European Medicines Agency (EMA) * Food and Drug Administration Vaccine Adverse Event Reporting System (FDA VAERS) * Medicines and Healthcare Products Regulatory Agency (MHRA) ## Supported File Types for Document Attachments & Literature References Vault supports the following file types for document attachments and literature references: |Format Name|Extensions|Notes| |-----------|----------|-----| |Bitmap|*.bmp|FDA VAERS only.| |DICOM Medical Imaging File|*.dcm|| |HyperText Markup Language (HTML)|*.html|FDA VAERS does not accept HTML files.| |JPEG|*.jpeg|| |Microsoft Excel Document|*.xls, *.xlsx|| |Microsoft Word Document|*.doc, *.docx|FDA VAERS accepts *.doc but not *.docx.| |Portable Document Format (PDF)|*.pdf|| |Rich Text Format|*.rtf|| |Plain Text File|*.txt|| |Tagged Image File Format|*.tif, *.tiff|| ## Prerequisites To use all of the features described on this page, your Admin must enable: * Literature E2B Retransmission: Supports retransmitting literature attachments populated on Cases linked to Literature Articles. * Excluding Attachments and Literature Documents: Enables choosing whether E2B(R3) files will include or exclude attachments and literature documents. * Destination-Specific Case Document Management Improvements: Controls attachment and document inclusion on E2B(R3) formats based on the [reporting destination][2]. ## 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_][3] 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_][4] criteria. ### 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 Literature Reference(s) 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 the C.4.r.1 Literature Reference(s) data element. ## 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 ICSR _Transmission_. 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][6] and the [destination-specific attachment type][5]. 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][1] and the [destination-specific attachment type][5], 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. [1]: #lit-attachments [2]: #destination-docs [3]: #attach-incl-control [4]: #lit-incl-control [5]: #destination-types [6]: #document-attachments