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.
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.
About the Summary Page
Coder opens automatically to the Summary page. The Summary page lists the Forms requiring coding, including the Sponsor and Study for each Form, the form’s Status, the Dictionary and Synonym List assigned to a Form, and other high-level metrics.
- 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: Any type of Form configured for coding.
Open a Form for Coding
To open a Form for coding:
Vault Coder opens the Listing page. This page contains all the terms that require coding for the selected form.
Columns in the Form List
The Summary page’s Form list includes the following columns:
|Sponsor||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 a custom form)|
|Coding Form Status||The form’s Status (either Active or Inactive)|
|Dictionary||The WHODrug or MedDRA dictionary release assigned to the Study|
|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
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 its coding status, assigned code, coding suggestions, query status, and note status. You can learn more about viewing Code Requests in this area here.
WHODrug Code Request Listing Columns
For WHODrug Forms, the Code Request Listing displays the following columns:
|Verbatim||The exact term entered in a form used to describe a concomitant medication.|
|Indication||A valid reason to use a medication.|
|Route||The path by which a drug is taken into the body. Routes can include oral, injection, IV, sublingual, and topical.|
|Status||The Code Request’s Status: Open, Uncoded, Noncurrent, Updated, Coded, or Autocoded.|
|Assigned Code||This area contains the WHODrug code, once the term has been coded.|
|Suggestions||Displays coding suggestions generated by Coder.|
|Queries||Indicates if there is a Query for an individual Code Request, gives the status of the query, and shows the age of the query in days.|
|Notes||Indicates if there is a Note for a Code Request.|
|Age (D)||Age of the Code Request in days.|
MedDRA Code Request Listing Columns
For MedDRA Forms, each Code Request in the Code Request Listing displays the following columns:
|Verbatim||The exact term entered in a form used to describe an adverse event|
|Seriousness||Indicates if the adverse event is serious or not|
|Status||The Code Request’s status (Open, Uncoded, Noncurrent, Updated, Coded, or Autocoded)|
|Assigned Code||After the term is coded, this column displays the code.|
|Suggestions||Displays coding suggestions generated from the form’s assigned Synonym List|
|Queries||Indicates if there is a Query for the Code Request. If there is a query, the query status icon indicates the query status and shows the number of days the query has been in that status.|
|Notes||Indicates if there is a Note for a Code Request|
|Age (D)||Age of the Code Request in days|
For instructions on using the table see Viewing Code Requests
The Coding panel is located in the bottom portion of the Code Request Listing page. It contains the Suggestions and the Dictionary subtabs.
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.
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).
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.