Import an Inbox Item

Vault Safety can import XML files in E2B(R2) or (R3) format and from Intake API to create Inbox Items. You can also create Inbox Items for literature reports from imported non-E2B files or document placeholders.

About Inbox Item Import

You can create Inbox Items from E2B XML files or from non-E2B files, such as literature reports in PDF files.

E2B Import Overview

When you create an Inbox Item from an E2B XML file, Vault 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 maps E2B data to a Case. PMDA E2B(R3) Case Import describes how Vault maps E2B data to Japan-specific objects and fields.

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

• Receive an E2B Transmission through an AS2 Gateway or through the Vault API from JSON files.
• Trigger the Create Inbox Item From Document action from an E2B document in the Vault Library. You can upload a single E2B file, a batch XML file (multi-E2B), or a ZIP file containing multiple E2B(R2) or (R3) compliant XML files. You can upload up to 1000 E2Bs in a multi-E2B and ZIP file.
• Send an email with an E2B XML or ZIP file attachment. For more information, see Email to Inbox Item.

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

Duplicate E2B XML File Detection

When importing XML files received from a multi-E2B or ZIP file, Vault may detect duplicate files already successfully imported into your Vault and creates the Inbox Items in the Duplicate lifecycle state. Vault also links each duplicate file to the original version already in your Vault, which you can view in the Duplicated Documents section on the Doc Info page for both files. For Vault to detect duplicate files, the organization’s associated Transmission Profile must have the Enable E2B Document Duplicate Detection field set to Yes.

Prerequisites for E2B Files

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

• 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 Vault must be finished generating a viewable rendition of the document.
  About Auto-Generated Viewable Renditions provides more information about viewable renditions. The XML document or the ZIP file must be uploaded using the Case > Source > Adverse Event Report classification and be in the New state.
  Adding Documents provides instructions on adding documents to the library.
• The Vault Library must contain the appropriate Organization, Product, and Study records. Otherwise, Vault 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 MedDRA dictionary configured.
  • 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.

Non-E2B Import Overview

When you create an Inbox Item from a non-E2B file, Vault creates a blank Inbox Item that you can use for manual intake. You can also generate an Inbox Item from a document placeholder record and capture the citation in the Reference field of the document metadata.

Prerequisites for Non-E2B Import

Consider the following prerequisites for importing an Inbox Item from a non-E2B file, such as a PDF of a literature report:

• The literature report classification must be Case > Source > Literature and the record must be in the Imported state.
  Adding Documents provides instructions on adding documents to the library.
• Your Admin must have configured the Create Inbox Item From Document action.
• Your Vault must have the Allow Attachments option enabled for the Case > Source > Literature document type.

Import an Inbox Item

Complete the following steps to import an E2B or non-E2B file to an Inbox Item. The Create Inbox Item From Document action is available only for the latest document version. For E2B files, before performing step 3, ensure Vault has generated a viewable rendition of the document.

1. Navigate to the document or placeholder in the Vault Library.
2. Verify that the following document fields are populated:
   • Organization: (Required) Select the organization that will process the Inbox Item and Case.
     The Organization Type must be Sponsor.
   • Receipt Date: (Optional) Select the receipt date. Vault snapshots this field to the Inbox Item New Info Date. If you don’t specify this field, Vault sets it to the current date, by default.
   • Report Type: (Optional) If not specified in the E2B data, select the report type. If left blank, Vault sets the Report Type to Spontaneous on the Inbox Item.
     Vault uses the values in these fields to populate the corresponding fields on the resulting Inbox Item and Case.
   • Reference: For documents or placeholders with the Case > Source > Literature classification, enter the citation for a literature article.
3. In the All Actions menu, select Create Inbox Item From Document.

Result

Vault imports the document to create an Inbox Item. Once created, Vault populates links in the Inbox Item and Inbound Transmission fields of the document.

For E2B files, Vault also does the following:

• 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 > Single-Case Document section and the parent XML file under the Relationship > Multi-Case Document section in each single-Case Vault document.
• Applicable duplicate files already imported into your Vault link to the original version, which you can view in the Duplicated Documents section on the Doc Info page for both files.

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

Case Access Groups

When an Inbox Item is generated from an E2B file, Vault 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.

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

Import E2B Inbox Items from a Zip File

You can create Inbox Items from a ZIP file containing multiple E2Bs. To do this, go to the ZIP file in the Library, expand the All Actions menu, and select Create Inbox Item from Doc.

Result

Vault imports each file individually as a document and creates an Inbox Item from each document. For any duplicate files previously imported into your Vault, the generated Inbox Items are in Duplicate lifecycle states for any applicable files.

Vault 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 > Single-Case Document section and the parent ZIP file under the Relationship > Multi-Case Document section in each single-Case Vault document.
• Applicable duplicate files already imported into your Vault link to the original version, which you can view in the Duplicated Documents section on the Doc Info page for both files.

Vault 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 Vault will log a warning for the non-E2B files. If Vault is unable to process the ZIP file, an error message appears 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

Vault 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).

You can access the CSV file in two (2) ways:

• If the Sender-Based Inbound Validation feature is enabled, go to the respective Inbox Item’s Inbound Validation Result section.
• If the Sender-Based Inbound Validation feature is not enabled, go to the E2B document in the Library. Select the Document Files 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:

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, there are two (2) import options using pre-defined mapping:

• Import a multi-Case CSV file to Inbox Item.
• Import a multi-CSV ZIP file to Inbox Item. You can also include tabular data files with a TXT extension within the ZIP as it follows the same convention as CSV.

Each multi-Case file can include up to 1,000 Cases.

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

Prerequisites

Before you can use this feature, your Admin must:

• Enable Safety Inbox Loader Multi-Case Tabular Data Import
• Manage Safety Inbox Loader Multi-Case Tabular Data Import

Prepare a Multi-Case File

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

• No files are empty.
• Each CSV contains at least one (1) record (at least one row of Case data).
• Each CSV contains at least one (1) column that is mapped to a Case ID (either Worldwide UID (WWUID) or External System UID).
• Each CSV must be sorted by Case ID.
• The number of rows per CSV does not exceed 100,000.
• The number of Cases per multi-Case file does not exceed 1,000.
• Each file contains unique column headers (except for the Case ID and Record ID columns).
• The ZIP file does not contain more than 50 CSV files.
• The CSV file size is equal to or less than 100 MB.
• The ZIP file size is equal to or less than 50 MB.
• The file list separator is a comma, semicolon, or a pipe character ( | ).
• The file character encoding is UTF-8, EUC-KR, or ISO-8859-1 (VAERS only).
• The date is in one of the following formats:
  • yyyy-MM-dd'T'HH:mm:ss.SSSXXX
  • (VAERS) MM/dd/yyyy'T'HH:mm:ss.SSSXXX
  • (KAERS) yyyyMMdd'T'HH:mm:ss.SSSXXX

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.

Prepare a Multi-Case File for VAERS

In addition to the criteria in the previous section, a CSV file for VAERS symptoms must follow a given format:

The VAERS format allows up to five (5) symptoms per row. Subsequent symptoms should continue in a new row with the same VAERS ID.

The column names must also follow the SYMPTOM# and SYMPTOMVERSION# naming convention. For example, “SYMPTOM1” and “SYMPTOMVERSION1”. Vault maps the VAERS data to Inbox Item records based on the naming convention. For example, SYMPTOM1 and SYMPTOM2 data are mapped to two (2) different records.

Create Inbox Items from a Multi-Case File

Once the CSV or ZIP file has been prepared, see Adding Documents to learn how to upload the file to your Vault. Ensure the document type is Case > Source > Adverse Event Report, and the Tabular Data Format field is populated.

After uploading the 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 the Error state. If uploading a ZIP file, Vault unzips the file into individual CSV documents and performs validation on each.

Multi-Case File Import Validation

After running the Create Inbox Item action, Vault validates the following:

• The files’ encoding matches the Tabular Data Format’s Encoding field value, if specified. If the encoding differs or is blank, Vault defaults to UTF-8.
• If the Case Contact type is not specified, Vault imports the Case Contact data to the Reporter object type.
• If the Country on the selected Tabular Data Format is specified, Vault maps to the Event Country and Reporter Country fields on the Inbox Item. Otherwise, these fields are populated with the source file data based on the mapping.

The following system validation applies to ZIP file import:

• The selected Tabular Data Format must contain a source file mapping to the Case (case_version__v) object. Otherwise, Vault does not import the Vault document and moves it to the Error state.
• If a CSV file is specified as a source file for the selected Tabular Data Format, it must exist in the ZIP file being imported. Otherwise, Vault does not import the Vault document and moves it to the Error state.
• If CSV files are specified as source files for the selected Tabular Data Format, Vault only validates these files during ZIP import and will ignore all other files present. If unspecified CSV files are present in the ZIP being imported, Vault logs this as a Global Warning in the Import Log.

For more information on configuring Tabular Data Formats and Tabular Source Files, see Manage Safety Inbox Loader Multi-Case Tabular Data Import.

Vault 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.

Multi-Case File Import Mapping

If validation is successful, this action creates a Vault document for each unique Case ID with the Case > Source > Adverse Event Report classification. When importing a ZIP file, if multiple column headers across different CSV files have the same record ID and are mapped to the same object and field, Vault groups this data in the same record (if not duplicates). Similarly, Vault groups parent and child record data together if the parent ID column header is mapped to the parent object and field as well as to the child object.

Next, for each single-Case document, Vault 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
• Case Adverse Event
• Case Assessment
• Case Assessment Result
• Case Drug History
  This object is also supported for Cases of Parent Information object type.
• Case Drug History Substance
  This object is not supported for Cases of Parent Information object type.
• Case Medical History
  This object is also supported for Cases of Parent Information object type.
• Case Product
• Case Product Dosage
• Case Product Indication
• Case Product Substance
• Case Test Results
• Reporter Case Contact

Vault ignores unsupported objects and fields. Download the list of fields that are not supported.

For more information on how to configure field import mapping from the tabular data to the Inbox Item, see Manage Safety Inbox Loader Multi-Case Tabular Data Import.

On the Inbox Item, Vault 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, Vault attaches an import log to each multi-Case CSV source file and you receive a Vault notification and an email. Vault also links the single-Case Vault documents in the parent multi-Case files under the Relationship > Single-Case Document section and the parent multi-Case file under the Relationship > Multi-Case Document section in each single-Case Vault document.

The Multi-Case Import Log

If your Admin allowed attachments for the Case > Source > Adverse Event Report document type, Vault 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 imported successfully
• Import Errors: Not all Cases imported successfully
• Failure: No Cases 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. Vault includes an error message in the import log for the Cases that failed to import.

Intake API Import

Inbox Items received from the Intake API appear in the Inbox automatically. Vault populates the Inbox Item fields if the information is available from the structured data. Vault records the details of the incoming API transmission in an Inbound Transmission record.

Imported MedDRA

If your Vault has an active MedDRA dictionary, Vault 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

Your Vault’s MedDRA dictionary supports auto-coding non-current terms during E2B or API import. This capability exists for all MedDRA-supported languages except Japanese.

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

When you import an E2B or API file that contains current terms from a MedDRA Version (for example, 18.0) older than the oldest MedDRA Version supported in your Vault’s MedDRA dictionary, Vault attempts to code the term if it exists using the active Vault MedDRA Version, and then your Vault’s latest available MedDRA Version. The imported Case displays a tag next to the coded term.

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, Vault looks at the Localization. If the Localization Type is local, Vault maps the localized data from the source file to the corresponding localized Inbox Item fields.

Prerequisites

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

Local Import MedDRA Autocode

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)

Vault also snapshots an LLT English term to the English text field.

Upon Case promotion, Vault 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:

• Perform Local Language to English Intake
• Enable the Auto-Translation Framework for Localized Intake and Case Submissions

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, Vault sends an email. If the import results in warnings or errors, Vault provides a notification on the Home tab. For example, if there are 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, Vault 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 Vault 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, Vault 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.

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

The Source Data pane displays both short text and long text for structured data. If any imported values map to inactive records, the values are displayed in the Source Data pane but are not populated in the corresponding Inbox Item field.

Import Suggestions

While importing Inbox Items, Vault Safety generates suggestions to assist with processing the Inbox Item. Vault clearly identifies suggestions with a lightbulb icon, along with a confidence calculation and rationale to make verification easy.

Vault Safety generates the following suggestions:

• Drug Role for Case Products
• Rank for Case Products
• Event Country for Medical Events
• Priority

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. Vault auto-calculates and suggests the priority for new Inbox Items based on the adverse event seriousness provided in the source data. For more information about how Vault calculates priority, see Inbox Item Overview.

Edit an Inbox Item Priority

You can verify the suggested priority while verifying the data in the Inbox Item. You can also change the priority when needed.

1. Go to the Inbox tab and select the Inbox Item you want to verify.
2. Expand the Details section.
   
3. In the Priority field, select the new priority for the Inbox Item.
   

Inbox Item Significance

Vault can prioritize Follow-up Cases for processing by assigning a Significance value to Inbox Items. This value is based on whether updates were made to the Case seriousness, expectedness, or relatedness.

Prerequisites

Consider the following prerequisites:

• Before you can use this feature, your Admin must enable Automated Classification of Inbox Item Significance.
• To automate promoting Inbox Items after Significance classification, your Admin must enable Automated Case Promotion.
• To recalculate Significance, your Admin must configure the Recalculate Auto-Significance action.

How Vault Assigns Inbox Item Significance

For Inbox Items imported from the Safety-EDC Vault Connection, Vault sets a value in the Significance field. These values are based on Case seriousness, expectedness, and relatedness. The Significance field is blank when an Inbox Item is not successfully imported through the connection.

After importing an Inbox Item through the connection, Vault looks for a matching Case ID. If there is no matching Case ID, Vault classifies the Significance as Initial Case. If there is a matching Case ID, Vault classifies the significance.

Vault considers a Follow-up Inbox Item to be Urgent Significant Follow-Up or Significant Follow-Up when it introduces changes that affect Case seriousness, expectedness, or relatedness. These changes include adding new object or field information to the matching Case or when field values do not match. For more information on comparing Inbox Item object records and field values to a matching Case, see Inbox Item Follow-Up.

The tables below list the object and field changes that result in a significant outcome. For this criteria to apply, these fields must be added to the Inbox Item to Case Compare layout. To customize fields, see Configure the Inbox Item Follow-Up Case Compare Layout.

Urgent Significant Follow-Up

Object	Field	When is this Significance value assigned?
Case Cause of Death	Cause of Death (LLT)	Inbox Item field is populated
	Cause of Death (Reported)
Case	Date of Death	Inbox Item has a Date of Death
Case Adverse Event	Seriousness	Seriousness of the Inbox Item is Results in death or Life threatening
	Outcome	Outcome is Fatal on the Adverse Event of the Inbox Item
	Event (Reported)	Event (Reported) is Death on the Adverse Event of the Inbox Item

Significant Follow-Up

Object	Field	When is this Significance value assigned?
Case	Case Tags	Case Tag is SUSAR
	Age	Mismatching field values
	Sex
	Narrative Length
Case Adverse Event	Seriousness	New record or mismatching field values
	Outcome
	Event (Reported)
	Event (PT)
	Onset
Case Product	Product (Reported)	New record or mismatching field values
Case Assessment Result	Assessment Result	Mismatching field values

If the Inbox Item does not match any of the above criteria, Vault classifies it as Non-Significant Follow-Up.

Recalculate Auto-Significance

For Inbox Items imported from the Safety-EDC Vault Connection, if you make changes that may impact the Case seriousness, expectedness, or relatedness, you can run an action to manually recalculate Significance:

1. Gp to the Inbox tab, select the Actions menu next to the applicable Inbox Item.
2. Select Recalculate Auto-Significance.

How Vault Marks Inbox Items for Follow-Up

If enabled in your Vault, Vault uses the Automated Case Promotion logic for marking Inbox Items for follow-up. If Automated Case Promotion is not enabled in your Vault, Vault moves the Inbox Item to the Marked as Follow-up state and links it to the Case if the matching initial Case is not in a prohibited state for the Mark as Follow-Up option.

When marking an Inbox Item for follow-up, Vault also checks for any previously marked Inbox Items that are related to the same initial Case. The most recently created Inbox Item is moved to the Marked as Follow-up state, whereas previously created Inbox Items related to the same matched Case are moved to the Marked as Follow-up (Not Current) state. This behavior helps Intake users prioritize the most up-to-date Inbox Item for promotion to a Follow-up Case.

Vault identifies which Inbox Item is most recent using the New Info Date.

When you manually promote an Inbox Item to a Follow-up Case (either using the Create Follow-Up action or the Automated Case Promotion manual merge method), all other Inbox Items related to the same initial Case are moved to the Superseded state.