Sections in This Article
- About Inbox Item E2B Import
- About Inbox Item Intake API Import
- Local Inbox Item Import
- Verify an Imported Inbox Item
- Import Suggestions
- E2B Import Source Data Pane
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:
- Receive an E2B Transmission through an AS2 Gateway or Intake API
- Trigger the Create Inbox Item from Document action from an E2B document in the vault library
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, an admin must Enable E2B Import to Inbox Item.
.xmldocument in E2B format or the
.zipfile with multiple
.xmlE2Bs must already be in the Vault Library and the system must be finished generating a viewable rendition of the document.
.xmldocument or the
.zipfile must be uploaded using the Case > Source > Adverse Event Report classification and be in the New state in order to import the Inbox Item.
- 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.
- 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
- 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.
- 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.
- Ensure the system has finished generating a viewable rendition of the document.
Vault Help provides more information about viewable renditions.
- Once the viewable rendition is complete, expand the All Actions () menu, and then select the Create Inbox Item icon ().
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 and the system adds a link to the Inbound Transmission. The system also generates a CSV rendition of the E2B source data.
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.
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 () 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 documents link to the associated Inbox Item and Inbound Transmission from the Inbox Item field and Inbound Transmission field, respectively. The system also generates a CSV rendition of the E2B source data for each document.
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
.zipfile cannot exceed 300.
- Each E2B file must be an
.zipfile cannot contain multi-E2Bs.
- The E2B files must be in the root (top-level directory) of the
.zipfile or must be in a root folder in the file.
.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 () 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 Inbox Item Intake API Import
For more information about Inbox Items received through the Intake API, see Access Imported Inbox Items from Intake API.
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.
Upon Case promotion, the system maps the Inbox Item localized values to the Case and copies these values to the generated Localized Case.
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
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
To verify the results of the import, view the Vault notification, and then verify the data on the Inbox Item.
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 message. If a mapping issue occurs, manually enter the information on the Inbox Item.
Verify an Inbox Item
- Go to the Inbox Item that you want to verify.
- Expand each section on the page to view the extracted data.
- Compare the extracted and suggested field values with the information in the Source Data panel to ensure the information is correct and valid.
- Use the following actions to correct and verify the data:
- To edit a field or address suggestions or conflicts, click into the field.
- To remove a section, select Delete.
- To mark a section as verified, select Verify.
Note If the item contains invalid data, the system prevents you from verifying this section and shows a message identifying the invalid values. You are not required to verify each section before Case promotion, however, if the Inbox Item contains invalid data, an error will appear when you promote to Case.
- Continue onto the next section for verification and repeat these steps until each section on the Inbox Item is verified.
You can enter additional data and add records manually while you verify the Inbox Item. Inbox Item Field Reference provides more information.
When you verify each section on an Inbox Item, you ensure that the data is valid. Select the Edit button to modify sections that you've already verified.
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.
Vault Safety can generate the following suggestions:
- Drug Role for Case Products
- Rank for Case Products
- Event Country for Medical Events
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:
|P1||Results in Death
Other Medically Important Conditions
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.
- In the Inbox tab, select the Inbox Item you want to verify, and then expand the Details section.
- In the Priority field, select the dropdown menu, and then select the new priority for the Inbox Item.
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.
E2B Import Source Data Pane
When an Inbox Item is imported from an E2B file, the Source Data pane shows the field values mapped from the E2B file:
The Source Data pane displays both short text and long text for structured data.