Import an Inbox Item

Vault Safety can import XML files in E2B(R2) or (R3) format and from Intake API to create Inbox Items.

Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.

Note Depending on your Admin's configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization's business processes for guidance.

About Inbox Item E2B Import

When you create an Inbox Item from an E2B XML file, Vault Safety maps each E2B data element to populate the associated Vault Safety field. Because Inbox Items do not contain all Case fields, certain data does not appear until you promote the Inbox Item to a Case.

E2B Case Import Data Mapping describes how Vault Safety maps E2B data to a Case.

The following list outlines how you can import E2B files to create Inbox Items:

Note Automated Case promotion is possible for Inbox Items received through an AS2 Gateway Transmission, Intake API, and for Inbox Items created from an uploaded E2B file (single E2B, multi-E2B, or .zip file containing multiple E2B(R2) or (R3) compliant .xml files) if Enable Auto Promote is on for the system gateway or E2B document, respectively. User intervention, such as Inbox Item data entry and selecting the Promote to Case action, is not required for this process.

Once you create an Inbox Item from an E2B file, the system generates a CSV rendition of this E2B file.


Consider the following prerequisites for importing an Inbox Item from an E2B file:

  • For Vaults originally deployed in 21R1 or earlier, your Admin must Enable E2B Import to Inbox Item.
  • The XML document in E2B format or the ZIP file with multiple XML E2Bs must already be in the Vault Library and the system must be finished generating a viewable rendition of the document.

    Note The XML document or the ZIP file must be uploaded using the Case > Source > Adverse Event Report classification and be in the New state in order to import the Inbox Item.

    Add a Document provides instructions on adding documents to the library.
  • The system library must contain the appropriate Organization, Product, and Study records. Otherwise, the system cannot properly map information to these records.
  • To automatically code MedDRA terms when the E2B file contains reported medical terms with no MedDRA code, your Vault must have an active Central MedDRA dictionary.
    • To use automation to code reported terms that aren’t an exact match to the MedDRA dictionary or your MedDRA Synonym List, your Admin must enable Smart MedDRA Coding.
  • Your Vault must have the Allow Attachments option enabled for the Case > Source > Adverse Event Report document type in the Admin area.

Import an E2B Inbox Item

  1. Go to the document in the Vault Library.

    Note The Create Inbox Item action is only available for the latest document version. The user action does not appear for older versions.

  2. Verify that the following document fields are populated:
    • Organization: (Required) Select the Organization that will process the Inbox Item and Case.
    • Receipt Date: (Optional) Select the receipt date. The system snapshots this field to the Inbox Item New Info Date. If you don't specify this field, the system sets it to the current date, by default.
    • Report Type: (Optional) If not specified in the E2B data, select the report type. If you don't specify this field, the system sets the Report Type to Spontaneous on the Inbox Item by default.

    The system uses the values in these fields to automatically populate the corresponding fields on the resulting Inbox Item and Case. If you don’t see the Receipt Date or Report Type fields, contact your administrator to add these fields.
  3. Ensure the system has finished generating a viewable rendition of the document.
    Vault Help provides more information about viewable renditions.
  4. Once the viewable rendition is complete, expand the All Actions (All Actions) menu, and then select the Create Inbox Item icon (Create Inbox Item Action).

    Note If you don't see the Create Inbox Item user action, contact your administrator to ensure that the action has been made available.


The system imports the document to create an Inbox Item. Once created, the document Inbox Item field links to the Inbox Item.

The system also does the following:

  • Adds a link to the Inbound Transmission.
  • Generates a CSV rendition of the E2B source data.
  • For multi-E2B files, links the single-Case documents in the parent XML file under the Relationship > Supporting Documents section.

Learn how Case intake and Case promotion consider Inbox Items with Combination Products.

Case Access Groups

When an Inbox Item is generated from an E2B file, the system populates the Case Access Group field on the document. The Case Access Group is inherited from the associated Inbox Item and is read-only.

To view the Case Access Group for a document, go to the Document Information pane, expand the Case Information section, and check the Case Access Group field.

Note For the Case Access Group field to appear, your Admin must enable Case Access Group Security.

Manage Automated Case Promotion for E2B Imported Inbox Items

You can enable automated Case promotion when you upload E2B documents, whether it’s a single file, multi-E2B file, or a ZIP file containing multiple E2Bs. On the right panel in the General section, you must specify the following fields:

  • Enable Auto Promote: Yes.
  • Non-Serious Merge Method: Select a merge method for Non-Serious Cases.
  • Serious Merge Method: Select a merge method for Serious Cases.
Enable Automated Case Promotion for E2B Imported Inbox Items

Note If Automated Case Promotion fails, see Automated Case Promotion Error Troubleshooting for a workaround.

Import E2B Inbox Items from a Zip File

You can create Inbox Items from a ZIP file containing multiple E2Bs.
Go to the ZIP file in the Library, expand the All Actions (All Actions) menu, and select Create Inbox Item from Doc.


The system imports each file individually as a document and creates an Inbox Item from each document.

The system also does the following:

  • Adds a link on the documents to the associated Inbox Item and Inbound Transmission from the Inbox Item field and Inbound Transmission field, respectively.
  • Generates a CSV rendition of the E2B source data for each document.
  • Links the single-Case documents in the parent ZIP file under the Relationship > Supporting Documents section.

The system successfully processes the ZIP file if it is valid:

  • Each E2B file cannot exceed 25 MB.
  • The number of E2B files in the ZIP file cannot exceed 1000.
  • Each E2B file must be an XML document.
  • The ZIP file cannot contain multi-E2Bs.
  • The E2B files must be in the root (top-level directory) of the ZIP file or must be in a root folder in the file.

If the ZIP file contains any non-E2B files, only the E2Bs will be imported and the system will log a warning for the non-E2B files.
If the system is unable to process the ZIP file, an error message will appear with the error details and the appropriate next steps. You can manually resolve the issues and upload the file again.

About the CSV Renditions of Imported E2B Files

The system generates a CSV rendition of the E2B file once you create an Inbox Item from this E2B. The rendition can be generated for E2B(R2) and (R3) files (for example, through manual upload, AS2 gateway, or API).

To access the CSV file, go to the E2B document in the Library. Select the Document Files icon (doc-file-icon) on the right panel. The CSV rendition is available in the Attachments section.

The CSV file contains E2B source data in a readable format. The following is an example snippet of a CSV file:

CSV Rendition File Example Snippet

Note the considerations for CSV renditions:

  • Elements that do not exist in the ICH E2B(R2) or (R3) guidelines are not included in the file.
  • Embedded files for E2B(R2) are not supported.
  • If the CSV rendition fails to generate, the E2B file will also fail to import.
  • When viewing the rendition using your web-browser, long blocks of text (for example, case narratives) are truncated to around one-third of the page. The complete text block will be available in the downloaded CSV file.

About Multi-Case Tabular Data Import

With the Safety Inbox Loader, you can import up to 1,000 Cases to Inbox Items using pre-defined mapping.

This feature allows you to extract multiple Cases and child records from a CSV file to create multiple Inbox Items at once using the Create Inbox Item action.


Before you can use this feature, your Admin must:

Prepare a Multi-Case CSV File

Before you can upload the file, the multi-Case CSV must meet certain criteria to pass system validation. Ensure the following have been met:

  • The file contains at least one (1) record (at least one row of Case data).
  • The file contains at least one (1) column that is mapped to a Case ID (either Worldwide UID (WWUID) or External System UID).
  • The file must be sorted by Case ID.
  • The number of rows does not exceed 100,000.
  • The number of Cases does not exceed 1,000.
  • The file size is equal to or less than 100 MB.
  • The file list separator is a comma or semicolon.
  • The file character encoding is UTF-8.

Additionally, the CSV file must conform to the Safety Case field properties. For example, text field values must adhere to the maximum number of characters. See Inbox Item Data Entry Validation for more information on field criteria.

Create Inbox Items from a Multi-Case CSV File

Once the CSV file has been prepared, see Upload a Document to the Library to learn how to upload the file to your Vault. Ensure the document type is set to Case > Source > Adverse Event Report, and the Tabular Data Format field is populated.

After uploading the CSV file, select the Create Inbox Item action. If any of the criteria in the previous section are not met, an error message appears and the document moves to Error state.

If successful, this action creates a Vault Document for each unique Case ID with the Case > Source > Adverse Event Report classification.

Next, for each single-Case document, the system creates an Inbox Item and imports the data to the Inbox Item fields based on the selected Tabular Data Format. Imported data includes standard fields and the following supported objects:

  • Case
  • Reporter Case Contact
  • Case Product
  • Case Product Dosage
  • Case Product Indication
  • Case Adverse Event

The system ignores unsupported objects and fields. Select the button below to download the list of fields that are not supported.

The system also detects any duplicate records (rows) for Case Products, Dosages, Indications, and Adverse Events for a given Case ID and keeps only one (1) copy.

For more information on how the system maps the CSV data to the Inbox Item, see Manage Safety Inbox Loader Multi-Case CSV Data Import.

On the Inbox Item, the system sets the Intake Method to Import and the Intake Format to Tabular Data. You can use these fields to filter the Inbox Items and to create Inbox Views.

Upon import completion, the system attaches an import log to the multi-Case CSV source file and you receive a Vault notification and an email. The system also links the single-Case Vault Documents in the parent multi-Case CSV file under the Relationship > Supporting Documents section.

The Multi-Case CSV Import Log

If your Admin allowed attachments for the Case > Source > Adverse Event Report document type, the system generates a multi-Case import log and attaches it to the CSV file after creating the Inbox Items. You can find this log in the Document Files section of the respective source multi-Case CSV file.

The report includes the status of the import:

  • Success: All Cases were imported successfully.
  • Import Errors: Not all Cases were imported successfully.
  • Failure: No Cases were imported.

The report also includes the following warnings and errors:

Warning/Error Description
Global Warnings “Global” issues affect more than one Case record.
Global Errors These scenarios include:
  • Single-Case document creation failure.
  • Single-Case Vault Document creation failure.
  • Data extraction from the CSV file failure.
Single-Case Warnings These scenarios include:
  • When multiple values are specified for one Case field for the same Case ID.
  • When the date format is not supported.
Single-Case Errors If validation errors occur for a single Case, the import process continues for the other Cases. The system includes an error message in the import log for the Cases that failed to import.

About Inbox Item Intake API Import

For more information about Inbox Items received through the Intake API, see Access Imported Inbox Items from Intake API.

Imported MedDRA

If your Vault has an active MedDRA dictionary, the system auto-codes MedDRA terms when the imported file contains reported medical terms with no MedDRA code.

If your Admin has configured your Vault for Smart MedDRA Coding, MedDRA coding is enhanced through AI and automation. When enabled, the feature supports coding reported terms that are not an exact match to the active MedDRA dictionary or your MedDRA Synonym list. For example, Smart MedDRA Coding offers suggestions for misspelled terms, abbreviations, ambiguous information, multiple reported terms, and more. For more information, see Code MedDRA Terms.

Case MedDRA Version

When a Case is imported to an Inbox Item, the Case MedDRA Version is set by the Vault’s active MedDRA Version.

Import Non-Current MedDRA Terms

The centralized MedDRA dictionary supports auto-coding of non-current terms during E2B or API import. This capability exists for all MedDRA-supported languages except Japanese.

The Recode-Tag tag is displayed when the E2B or API MedDRA Version is not in sync with the Case MedDRA Version or if the coded term is non-current.

Recode Tag Displayed Next to MedDRA Term from Import

When you import an E2B or API file that contains current terms from an older MedDRA Version (for example, 18.0) than the oldest MedDRA Version supported in MedDRA central, the system will attempt to code the term if it exists. The Imported Case will display a Recode-Tag tag next to the coded term.

Note Coding of non-current terms is not supported when the E2B or API file contains a term that only exists in versions of the MedDRA dictionary that are newer than the latest supported MedDRA Version in MedDRA central.

Local Inbox Item Import

Local Case import is available for Inbox Items imported from E2B and Intake API.

When a Case is imported to an Inbox Item, the system looks at the Localization. If the Localization Type is local, the system maps the localized data from the source to the corresponding localized Inbox Item fields.


Your Admin must first enable local Case Import before you can use this feature.

Local Import MedDRA Autocode

Note MedDRA Autocode upon local import is only available for Inbox Items imported from API and not E2B.

Vault Safety can autocode the following fields upon import if the local Case is imported without a MedDRA code and is in a non-English MedDRA language:

  • Products section: Indication
  • Medical Events section: Event (Reported)

The system also snapshots an LLT English term to the English text field.

Local Case Import MedDRA Autocode

Upon Case promotion, the system maps the Inbox Item localized values to the Case and copies these values to the generated Localized Case.

Additional Resources

Upon local import, Inbox Item text fields can be translated to English using Amazon Translate. For more information, see:

Note that if your Admin has selected the enable auto-set Inbox Item Localization by Reporter Country checkbox and the Inbox Item has a primary Reporter-type Case Contact, the Localization field on the Inbox Item is automatically set based on the Reporter Country. For more information, see the Inbox Item Field Reference.

Verify an Imported Inbox Item

Upon E2B or API import, Vault Safety automatically verifies the Inbox Item records and sections. Records and sections with no validation errors are marked as Verified.

If there are validation errors, you can manually update the Inbox Item and verify the records.

To verify the results of the import, view the Vault notification, and then verify the data on the Inbox Item.

Vault Notification

When an Inbox Item has been created from a document, the system provides the results of the import by logging a notification on the Home tab and sending an email.

If there are any issues mapping data from an E2B file, the notification includes a warning message explaining the affected E2B data element and value. For API import issues, the system also includes a warning message. If a mapping issue occurs, manually enter the information on the Inbox Item.

Verify an Inbox Item

To modify sections that the system has already verified, select Edit. Otherwise, complete the following steps to edit or manually verify sections:

  1. Go to the Inbox Item that you want to verify.
  2. After confirming the Inbox Item is a valid Case, select the Promote to Case action.
    If there is any invalid data, a window appears and lists the affected sections.
  3. Navigate to each section to correct the invalid data.
    For the Case Contact, Product, and Event sections, the system displays the number of records with invalid data in the top right of the section.
  4. Review and correct the field validation errors in the respective section or record.
    Use the following actions to correct and verify the data:
    • To edit a field or address suggestions, select Edit.
    • To remove a section, select Delete.
    • To mark a section as verified, select Verify.

      Note If a section contains invalid data, the system prevents you from verifying this section and shows a message identifying the invalid values.

    You can enter additional data and add records while you verify the Inbox Item. Inbox Item Field Reference provides more information.

Import Suggestions

While importing Inbox Items, Vault Safety generates suggestions to assist with processing the Inbox Item.

The system clearly identifies suggestions with a lightbulb icon, along with their confidence level and rationale to make verification easy.

AI Suggestion
Inbox Item Import Suggestion

Vault Safety can generate the following suggestions:

  • Drug Role for Case Products
  • Rank for Case Products
  • Event Country for Medical Events
  • Priority
    See Inbox Item Priority Auto-Calculation below to learn more about how priority is suggested.

Inbox Item Priority Auto-Calculation

Cases should be processed in a timely manner based on their priority. When there is a high volume of Cases, it is crucial to determine Case priority quickly.

The system auto-calculates and suggests the priority for new Inbox Items based on the adverse event seriousness provided in the source data. The following table outlines how the system assigns priority:

Priority Level Seriousness
P1 Results in Death

Life Threatening

P2 Caused/Prolonged Hospitalization


Congenital Anomaly

Birth Defect

Other Medically Important Conditions

P3 Not Serious

Seriousness information was not found

Edit an Inbox Item Priority

The user can verify the suggested priority while verifying the data in the Inbox Item. They can also change the priority.

  1. In the Inbox tab, select the Inbox Item you want to verify, and then expand the Details section.
    Verify Priority
    Inbox Item priority
  2. In the Priority field, select the dropdown menu, and then select the new priority for the Inbox Item.
    Change Inbox Item Priority
    Change the Inbox Item Priority


The Inbox Item is assigned a new priority.

The user can display Inbox Items with a higher priority by filtering for these items. See Filter and Sort Inbox Items for more information.

Import Source Data Pane

When an Inbox Item is imported from an E2B file or integration with an upstream system, the Source Data pane shows the field values mapped from the file:

E2B Import Source Data Pane
Import Source Data Pane

The Source Data pane displays both short text and long text for structured data.

If any imported values map to inactive records, the value is displayed in the Source Data pane but is not populated in the corresponding Inbox Item field.

Manual Inbox Item Intake
Inbox Item Study and Product Matching