Navigating Vault Coder

The Vault Coder application consists of two main pages: the Summary page and the Listing page.

  • The Summary page lists all the forms that are assigned to you for coding.
  • The Listing page lists the Code Requests for an individual coding Form. You perform coding in the Listing page.

Accessing Coder

To open Vault Coder, click the Coder tab in the top navigation bar. Depending on your permissions, Vault may open to this tab by default after you log in.

Vault Coder tab

About the Summary Page

Coder opens automatically to the Summary page. The Summary page lists the Forms requiring coding in a table that includes the following information for each record:

  • The Organization and Study for each Form
  • The form’s Status
  • The Dictionary and Synonym List assigned to a Form
  • Other high-level metrics, including:
    • Pending Coding
    • Open Queries
    • Pending Approval
    • Coded
    • Autocoded

Summary page listing AE, Medical History, and ConMed forms

Coding Forms:

Coding is performed on the following types of forms::

  • ConMed: Form for concomitant medications (medications that a patient is taking concurrently with the trial drug, while participating in the clinical study). Vault Coder uses the WHODrug dictionary with this type of form.
  • Adverse Event: Form for the adverse events that subjects experience while taking the trial drug. Vault Coder uses the MedDRA dictionary with this type of form.
  • Medical History: General patient Medical History form.s
  • Custom Forms (Other): Any other type of Form configured for coding.

Open a Form for Coding

To open a Form for coding:

  1. Click to open the Coder tab in the top navigation bar. Vault Coder tab

  2. In the Summary page, click a Form to open it. Select Form

  3. Vault Coder opens the Listing page. This page contains all the verbatims that require coding for the selected form.

Columns in the Form List

The Summary page’s Form list includes the following columns:

Column Description
Organization The name of the study’s Sponsor
Study This is the name of the Study that the Form belongs to
Form The type of form (WHODrug, MedDRA, Medical History, or other form)
Coding Form Status The form’s Status
Dictionary The WHODrug, JDrug, or MedDRA dictionary release assigned to the Form
Synonym List The Synonym List assigned to the Form
Pending Coding Number of Code Requests in the Open, Uncoded, Noncurrent, and Updated statuses
Open Queries Number of Code Requests that have an open Query
Pending Approval Number of Code Requests that have been assigned a code but have not yet been approved by a coder manager or administrator. Vault Coder only fills this column for Forms in Studies using the Coder Approval Workflow feature. Studies not using this feature have “N/A” in this column.
Coded Number of Code Requests in the Coded status.
Autocoded Number of Code Requests in the Autocoded status.

About the Listing Page

The Listing page is divided into three areas: the Code Requests listing, the Coding panel, and the Code Request Properties panel.

Code Request Listing page components

Code Request Listing

Each row in the Code Request listing represents a Code Request. By default, Code Requests are sorted in alphabetical order. From the Code Request Listing, you can search for Code Requests and select them for coding. You can also view details for each Code Request, including the following:

  • C*oding status
  • Assigned code
  • Query status
  • Note status

Learn more about viewing Code Requests.

WHODrug Code Request Listing Columns

For WHODrug Forms, the Code Request Listing displays the following columns by default:

Code Request Listing for a WHODrug form
Code Request Listing for a WHODrug form
Column Description
Verbatim The exact term entered in a form used to describe a concomitant medication.
Indication If configured: A valid reason to use a medication.
Route If configured: The path by which a drug is taken into the body. Routes can include oral, injection, IV, sublingual, and topical.
Coding Status Status of the Code Request: Open, Uncoded, Noncurrent, Updated, Coded, or Autocoded.
Assigned Code The WHODrug code (after verbatim is coded).
Queries Query information for an individual Code Request, including the status of any queries and the query age in days.
Notes Whether there is a Note for a Code Request.

MedDRA Code Request Listing Columns

For MedDRA Forms, each Code Request in the Code Request Listing displays the following columns by default:

Code Request Listing for a MedDRA form
Code Request Listing for a MedDRA form
Column Description
Verbatim The exact term entered in a form used to describe an adverse event
Seriousness If configured: Indicates if the adverse event is serious or not
Coding Status Status of the Code Request: Open, Uncoded, Noncurrent, Updated, Coded, or Autocoded
Assigned Code The MedDRA code (after verbatim is coded)
Queries Query information for an individual Code Request, including the status icon of any queries and the age of the query in days
Notes Whether there is a Note for a Code Request

For instructions on using the table see Viewing Code Requests

Coding Panel

The Coding panel is located in the bottom portion of the Code Request Listing page. It contains the Suggestions and the Dictionary subtabs.

Suggestions Subtab

Once you select a Code Request in the Code Request Listing, Vault compares the properties of the selected Code Request to records in the assigned dictionary. If Vault Coder finds relevant codes, it offers them as coding Suggestions in the Coding panel’s Suggestions subtab.

Suggestions subtab for a WHODrug form
Suggestions subtab for a WHODrug form
Suggestions subtab for a MedDRA form
Suggestions subtab for a MedDRA form

Dictionary Subtab

After you select a Code Request in the Code Request Listing, Coder performs a search for the Verbatim of the selected Code Request in the appropriate dictionary and displays a list of the entries found, including codes for each entry, in the Dictionary subtab. The Dictionary subtab displays matching records from the appropriate dictionary release (WHODrug or MedDRA).

Dictionary subtab for a WHODrug form
Dictionary subtab for a WHODrug form
Dictionary subtab for a MedDRA form
Dictionary subtab for a MedDRA form

For further instructions on using the Coding Panel see Using the Coding Panel

Code Request Properties Panel

The Code Request Properties displays full details for the assigned code in the Assigned Code area. The panel also has three cards for Properties, Queries and Notes.

Code Request Properties panel for a WHODrug form with the Properties card selected
Code Request Properties panel for a WHODrug form with the Properties card selected
Code Request Properties panel for a MedDRA form with the Properties card selected
Code Request Properties panel for a MedDRA form with the Properties card selected