Learn how to intake data from unstructured and semi-structured source documents, highlight words and phrases within a document to populate fields in the Document Intake panel, generate an Inbox Item mapped to those source document field values, and promote it to a Case.
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 the Document Intake Panel
The Document Intake panel is available on the Doc Info page of Adverse Event Report documents. The panel includes sections and fields that map to Inbox Item sections and fields. As you review data in the document, you can populate fields with content in the source document manually or using the highlight annotation tool, which adds sticky comment annotations so you can easily trace how field values map to the data in the document. After populating values in the panel, Vault generates an Inbox Item mapped to the values you sourced from the document. Any time you save changes to the values on a document or Inbox Item, Vault updates the corresponding record or document with the new values. If the generated Inbox Item meets all criteria to promote it to a Case, you can do so directly from the panel’s summary view. You can access the associated Inbox Item and Case from the Case section of the Document Information panel.
Note: For E2B files with structured data, we recommend running the Create Inbox Item from Document action to generate Inbox Items instead of utilizing the Document Intake panel.
Note: This feature is available for Early Adopters only. To learn more, contact your Veeva Representative.
Prerequisites
To utilize the Document Intake panel, you must have the following permissions:
- Permission to create Inbox Items
- An Editor or Owner document role for the Adverse Event Report document type
Access the Document Intake Panel
You can access the Document Intake panel by selecting the Document Intake () icon on the Doc Info page of Adverse Event Report classified documents of the following supported file formats:
- Electronic Mail File
- HyperText Markup Language
- JPEG
- Microsoft Word Documents
- Microsoft Powerpoint Presentations
- Portable Document Format
- Portable Network Graphics
- Microsoft Powerpoint Presentations
- Text
When you access the panel on a document not yet associated with an Inbox Item, you can immediately begin populating field values. For documents already associated with an Inbox Item, you will see the summary view.
Populate Inbox Item Fields
Use the Document Intake panel to populate fields to generate a new Inbox Item or update an existing Inbox Item based on data in the document viewer. You can populate values manually or use the highlight annotation tool to populate fields from content in the document. The fields available to populate in the panel required to generate an Inbox Item and promote it to a Case. These fields are maintained by Veeva and cannot be modified by your Admin. To create an Inbox Item without populating all required fields in the panel, you can manually create the record.
To populate Inbox Item fields in the panel:
- Navigate to the Adverse Event Report classified document in your Library. If you’re updating an existing Inbox Item, you can navigate here from the Source Document field in its Case Validity and Source section.
- On the Doc Info page, select the Document Intake () icon.
- If you’re updating fields for an existing Inbox Item, select the edit (
) icon. - Populate fields in the following panel sections as applicable. You can do this manually or by using the highlight annotation tool to map values directly to content in the document.
- Details: Specify report details. To generate an Inbox Item, you must specify New Info Date and Report Type, which you cannot populate using the highlight annotation tool.
- Country: Specify country details. To generate the Inbox Item, you must specify Reporter Country or Event Country.
- Event: Add up to ten (10) events. To promote the generated Inbox Item to a Case, you must add a primary Adverse Event.
- Product: Add up to ten (10) products. To promote the generated Inbox Item to a Case, you must add a primary Product.
- Patient: Specify patient details.To promote the generated Inbox Item to a Case, you must populate at least one (1) of these fields.
- Reporter: Specify reporter details. To promote the generated Inbox Item to a Case, you must populate at least one (1) of these fields.
- When you’re done making changes, select Save.
After saving changes, review your entries on the summary view. If Vault finds no validation errors for the populated fields in the panel, it generates or updates the applicable Inbox Item based on the values you entered in the panel. You can access the Inbox Item from the Case section of the Document Information panel to review and update fields, as needed. If you make any changes to fields on the Inbox Item, Vault syncs them to the panel. You can navigate back to the panel from the Source Document field on the Inbox Item.
Specify Country Details
If country details are known, we recommend populating these fields before adding events and products so that Vault applies the specified countries to those items. When you populate Reporter Country, Vault applies the same value for the Event Country and Product Country fields. To specify a different country for either of these fields, clear the applicable Same as Reporter checkbox and then populate a different value for that field. If you leave the checkbox selected for either field, Vault applies the same value you populate for Reporter Country.
Add Events
Add up to ten (10) events in the panel. You can add additional Medical Events directly to the Inbox Item, but the panel displays only the first ten (10) created events. By default, events you add in the panel are of the Adverse Event type. To view and add different types, select the applicable button:
- Event: Adds an Adverse Event
- History: Adds a Medical History & Concurrent Condition
- Complaint: Adds a Product Quality Complaint
When you add an event, Vault auto-codes terms with exact matches to a MedDRA dictionary term or synonym. If Vault finds a match, you can review details by hovering over the underlined item. Hover over a listed item to access the following options:
- Mark as primary (
): Select this to specify an item as the primary adverse event for the report. - Auto-code (
): If you update a previously entered term, select this to match and code the MedDRA term. Select the icon again to Clear Auto-code (
). - Assign Seriousness Criteria (
): Select this to reveal checkboxes you can select to assign seriousness. Vault displays the selected criteria below the item.
To view all products without filtering by type, unselect all buttons. You can drag and drop items to rearrange the order and move them into different product sections to change their type.
Note: You cannot delete items in the panel. You must delete them from the generated Inbox Item.
Add Products
Add up to ten (10) products in the panel. You can add additional Products directly to the Inbox Item, but the panel displays only the first ten (10) created Products. By default, products you add in the panel are Case Products with the Suspect type of Drug Role. To view and add different types, select the applicable button:
- Suspect: Adds a Case Product with a Drug Role of Suspect
- Interacting: Adds a Case Product with a Drug Role of Interacting
- DNA: Adds a Case Product with a Drug Role of Drug Not Administered
- Conmed: Adds a Case Product with a Drug Role of Concomitant
- Treatment: Adds a Case Product with a Drug Role of Treatment
- History: Adds a Drug History
Note: You cannot add Case Products with a Drug Role of Similar Device using the panel.
When you add a product, Vault auto-codes terms with exact matches to a MedDRA dictionary term or synonym. If Vault finds a match, you can review details by hovering over the underlined item. Hover over a listed item to access the following options:
- Mark as primary (): Select this to specify an item as the primary product for the report.
- Auto-code: If you update a previously entered term, select this to match and code the MedDRA term. Alternatively, select the binoculars (
) icon to open the Product Browser. Select Clear Selection to remove the code.
To view all products without filtering by type, unselect all buttons. You can drag and drop items to rearrange the order and move them into different product sections to change their type.
Note: You cannot delete items in the panel. You must delete them from the generated Inbox Item.
Highlight Annotation Tool
The highlight annotation tool allows you to select content within a document to populate certain fields in the Document Intake panel. Using this tool is similar to annotating documents. When you highlight content in the document, Vault creates a sticky comment annotation with details about the sourced data and maps it to the selected section in the panel. Use Annotate mode to view all sticky comment annotations, including any added using the highlight annotation tool. Vault uses different highlight colors for each section in the panel so you can visualize the different areas from which you’ve pulled source data, which are maintained by Veeva and cannot be modified by your Admin:
- Details: Light purple (
) annotations - Country: Dark green (
) annotations - Event: Light orange (
) annotations - Product: Dark pink (
) annotations - Patient: Light yellow (
) annotations - Reporter: Light green (
) annotations
Note: After adding comment annotations, we recommend that you do not change the color, edit the text style, or perform any actions.
For text fields, Vault populates the field with the exact text you highlighted. For fields that support certain values based on existing records or controlled vocabulary, Vault populates the field only if you’ve highlighted an exact valid text match to the available values for that field. For example, if you’re trying to populate the Gender field, which supports Female and Male values, and you highlight “Woman” within the document, Vault adds a comment and maps it to the field without populating it, since there is no exact matching value. When this happens, Vault displays the highlighted term below the field in the panel for reference. You can manually add the applicable field value in the panel.
Note: Moving or deleting a sticky comment annotation does not update or remove the mapped field value in the panel. You must manually update the field.
Use the Highlight Annotation Tool
To use the highlight annotation tool:
- Select the highlight () icon next to the field or section you want to populate.
- Highlight the word or phrase in the source document to map to the field.
- If you highlight valid text, Vault adds a comment and populates the selected field or adds the item.
- If you highlight invalid text, Vault adds a comment but does not populate the selected field or add the item.
- Optional: Modify the populated value as appropriate.
If you populated a field with a valid value, Vault unselects the highlighter and you can populate a different field or section. If you populated the Event or Product section, the highlighter remains selected until you do any of the following:
- Unselect the highlighter for that section
- Select the highlighter for a different section or field
- Add ten (10) items to that section
Note: If you exit the panel after populating fields without saving, Vault saves any sticky comment annotations you added but they are not mapped to fields in the panel.
Summary View
The Document Intake panel displays a summary of the Inbox Item values after saving changes and when viewing the panel for a document already associated with an Inbox Item. The summary view shows each section you can populate using the panel, which indicates that the identifiable criteria in each section are complete with a green checkmark (
) icon or incomplete with a grey checkmark (
) icon. The Event and Product section headers include the number of items in each section in parenthesis ([N]) next to the section name.
In the summary view, you can review the details for the generated Inbox Item:
- Review the status of each section:
- If any sections have grey checkmarks (), you must add required details to that section before you can promote the Inbox Item to a Case.
- If all sections have green checkmarks (), you can select the Promote to Case (
) icon to generate a Case. - Hover over a checkmark icon to view the identifiable criteria for that section.
- For any field you mapped using the highlight annotation tool, select the value to jump to the associated sticky comment annotation in the document viewer.
- Select a header to collapse () or expand () that section in the viewer.
- Select the edit () icon to populate fields.
Promote to Case
If you’ve added all details required to promote the Inbox Item to a Case, all sections have green complete checkmarks, and you can select the Promote to Case () icon at the top of the Document Intake panel summary view to promote the Inbox Item. You can access the generated record from the Case section of the Document Information panel to review and update fields, as needed. You can navigate back to the panel from the Source Document field on the new Case.