In Vaults using Veeva AI for Safety, the Intake Agent processes certain files to identify Adverse Event Reports (AERs) and extracts the relevant details for drug and biologic cases. The agent processes unstructured and semi-structured AER files (including handwritten files up to 20 pages) using a Large Language Model (LLM) to identify patient, reporter, country, product, and event data. When the agent identifies a potential Individual Case Safety Report (ICSR), Vault generates an Inbox Item with field values populated from the source document, adds annotations to highlight the specific text used for the extracted field values, and flags data anomalies for your review. After the agent completes, use the Document Intake Highlighter panel to validate the extracted data.
Note: The Intake Agent does not extract multiple ICSRs from a single file. The agent extracts only one ICSR, regardless of how many the file contains.
Prerequisites
Your Admin must enable the Intake Agent.
Run the Intake Agent
The Intake Agent runs in the following scenarios after Vault generates a viewable rendition for files of supported formats associated with applicable Transmission Profiles:
- Email to Inbox: Automatically, when Vault receives an emailed document.
- Document Upload: Automatically, when you upload an Adverse Event Report document.
- API Import: Automatically, when API users upload JSON files using the Intake API.
- Document Action: Manually, when you run the Extract ICSR with Intake Agent action.
When the agent runs, the document moves to the Importing state and Vault generates an Inbox Item. When the agent completes, the document moves to the Imported state and Vault populates the Intake Method field on the Inbox Item with Intake Agent. If the agent does not detect ICSR details in the source document, the Inbox Item is blank. If the agent encounters any errors, the document may move to the Error state and Vault does not generate an Inbox Item.
Note: Vault does not automatically promote Inbox Items generated by the Intake Agent. You must review the data before promoting.
Manually Run the Intake Agent
You can manually run the Intake Agent on existing Case > Source > Adverse Event Report classified documents not already associated with an Inbox Item. To run the agent, navigate to the most recent version of the document and select Extract ICSR with Intake Agent from the All Actions menu.
Review Extracted Data
After the Intake Agent runs, navigate to the Document Intake Highlighter panel to review and validate the extracted data on the Case Qualification tab. Vault lists any data anomalies on the Review tab. Use the panel to make any necessary updates to the Inbox Item fields based on the information in the source document. When you complete your review, you can promote the Inbox Item to a Case. The promoted Case may contain additional annotated data from the source document that does not appear in the panel fields.
Note: Always review the source file to verify the accuracy of extracted data.