Create an AER

You can create an Adverse Event Report (AER) manually or from a source document.

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You can create an Adverse Event Report and enter all information manually, or create an Adverse Event Report from a source document to automatically populate information.

Create an Adverse Event Report from a Document

With Vault Safety, you can create an AER from any kind of source document, including E2B (R2) or E2B (R3) files.

When you have a source document, we recommend that you upload and create the Adverse Event Report from that document. The information that the system can extract and populate on the Case depends on the file type.

Note AERs are being phased out. No new functionality is being added to AERs. Using the new Inbox (Inbox Item) is currently optional, but we recommend that customers start using Inbox Items in 21R3 (December 2021). All customers should be using Inbox Items for intake by 23R1 (April 2023).

Use an E2B File

When you create an Adverse Event Report from an E2B .xml file, the system maps each E2B data element to populate the associated Vault Safety field. You can also upload an E2B (R2) or E2B (R3) multi-case file to create multiple Cases from a single E2B file.

Note E2B multi-case files have a default maximum upload limit of 100 cases per file. This limit can be increased to 1000 cases per file by Veeva Support or product team member, upon request.

If your vault has an active MedDRA dictionary, the system automatically assigns MedDRA codes when the E2B file contains reported medical terms with no MedDRA code. Because Adverse Event Reports do not contain all Case fields, certain data does not appear until you promote the Adverse Event Report to a Case.

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

Note Before you import an E2B file, the system library must contain the appropriate Organization, Product, and Study records. Otherwise, the system cannot properly map information to these records.

Import an AER from an E2B File

  1. Go to the Library tab.
  2. From the menu bar, select Create Button. The Create Document window appears.
    If you do not see the Create button, you do not have permission to upload documents.
  3. On the Create Document window, select Upload > Continue.
  4. On the Upload Files (Step 1) page, drag and drop the E2B file into the blue area or select Choose to browse for the file on your device.
  5. Select Classify documents now, and then under Choose document type select Case › Source › Adverse Event Report.
  6. Select Next.
  7. On the Upload Files (Step 2) page, select the Organization.
  8. Select Save.
  9. Wait for the system to finish processing a viewable rendition of the document.
    Vault Help provides more information about viewable renditions.
  10. Once the viewable rendition is complete, expand the All Actions (All Actions) menu, and then select Create AER from Document.

    Note The Create AER from Document user action may differ depending on your Vault configuration (for example, “Create Imported Case from E2B” instead of “Create AER from Document.”)

Result

The system imports the document to create AER records. Once created, the document Case field links to created AER records. AER records created with an E2B(R3) multi-case file will send a status notification for each created record

Verify an E2B Import

When the Create AER from Document process is complete, the system logs a notification on the Home tab and sends an email notification with the results of the E2B import. To verify the operation succeeded, review the notification or email for the E2B import action.

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. If this issue occurs, manually map the information to the Adverse Event Report.

Use a Non-E2B Source File

When you create an Adverse Event Report from a source document, such as a .pdf literature source, the system links to the document and populates certain fields on the Adverse Event Report, using the document metadata. See Vault Metadata Auto-Population for more detail. The system also automatically populates the Source field on the AER with a link to the source document.

Create an AER from a Non-E2B Source File

  1. Go to the Library tab.
  2. From the menu bar, select Create Button. The Create Document window appears.
    If you do not see the Create button, you do not have permission to upload documents.
  3. On the Create Document window, select Upload > Continue.
  4. On the Upload Files (Step 1) page, drag and drop your file into the blue area or select Choose to browse for the files on your device.
  5. Select Classify documents now, and then under Choose document type select the document type.
    Typically, the document type is classified under Case › Source, but you can use any document type for which the Create AER from Document action is configured.
  6. Select Next.
  7. On the Upload Files (Step 2) page, specify values for the following fields:
    • Organization: (Required) Select the Organization that will process the Case.
    • Receipt Date: (Optional) Select the receipt date. If you don't specify this field, the system sets the Receipt Date to the current date on the AER by default.
    • Report Type: (Optional) Select the report type. If you don't specify this field, the system sets the Report Type to Spontaneous on the AER by default.
      The system uses the values in these fields to automatically populate the corresponding fields on the resulting AER and Case. If you don’t see the Receipt Date or Report Type fields, contact your administrator to add these fields.
  8. Select Save.
  9. Expand the All Actions (All Actions) menu, and then select Create AER from Document.

Result

The system imports the document to create an AER. Once created, the document Case field links to the AER record.

Vault Metadata Auto-Population

The Case > Source > Adverse Event Report document type contains the Organization, Receipt Date, and Report Type fields to capture and automatically populate this data when you create an Adverse Event Report from a document in the library.

Note An administrator can add these shared fields to any document type. When you create a Case, the system will auto-populate these fields as long as the Organization field is present and populated. You can also create an AER Case from a source document that contains none or one of these fields.

Create an Adverse Event Report Manually

  1. Go to the Inbox tab.
  2. Select Create Button.
    The Create AER page appears.
  3. Use the Create AER form to enter information from the Adverse Event Report.
    Enter Adverse Event Report Information provides more information.
  4. When you are done editing the Adverse Event Report, select Save.

Result

The AER is stored in the Inbox.


Inbox Item Field Reference
AER Field Reference
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