Vault Coder Overview

Vault Coder lets you code clinical terms for data on concomitant medications, adverse events, and medical history including prior surgeries. You can also create and code customized forms using Coder.

The dictionaries used within Vault Coder define clinical codes for concomitant medications, adverse events, and more:

  • WHODrug B3 and C3 versions (English), JDrug (Japanese): Provide codes for drugs, which are unique for each drug. These codes are used in statistical analysis to track interactions between drugs that a subject already uses and the trial drug, as well as drugs that the subject uses to control adverse events.
  • MedDRA 20.0+ (English), MedDRA/J (Japanese): Provide unique codes for medical conditions. The codes are used in clinical trials to code adverse events from taking a trial drug, as reported by subjects.

Coder conducts verbatim searches in the WHODrug and MedDRA dictionaries, lists search results, offers coding suggestions for individual Code Requests based on matching coding properties it finds in an assigned dictionary, lets you view the details and code associated with a drug or condition, and allows you to assign codes to Code Requests.

The application also allows you to build or import lists of previously coded verbatims and their properties to use within your study. The list is referred to as a Synonym List within the application. Once a synonym list has been added to the study, Coder will begin Autocoding. During autocoding, Coder will look for matches between pending Code Requests and items within the Synonym List. If it finds a match, it will Autocode the pending Code Request to the same code found in the Synonym List. You can also add to the Synonym List while coding. New additions will either be autocoded automatically or begin autocoding after being approved by a Coder Administrator.

Features

Vault Coder provides several features that improve coding efficiency:

  • Batch Coding: You can select multiple Code Requests and assign them the same code with one click.
  • Code + Next: Coder provides the Code + Next feature for rapid coding. Click Code + Next to quickly code a Code Request and automatically move to the next pending Code Request.
  • Synonym Lists: Coder allows you to create and add to Synonym Lists. Synonym Lists contain previously coded verbatims and their properties and are used to Autocode.
  • Batch Assign Lists: You can assign an upversioned Synonym List to multiple forms at once.
  • Autocoding: An automated feature which assigns a code based on a comparison between the coding properties of pending Code Requests and a Synonym List.
  • Queries: Clinical coders can use the Queries feature in Coder to communicate directly with sites. This is helpful if you need more information from the site in order to code a Code Request.
  • Notes: When a clinical coder codes a Code Request in a non-traditional way, they can post a Note in order to explain their reasoning.
  • Status Filter: Filters Code Requests by their Status: Open, Autocoded, Uncoded, Noncurrent, Coded and Updated.
  • Query Filter: Filters Code Requests by Query Status: Query to Site, Site Responded, Re-Queried Site.
  • Sorting: Code Requests are listed in a table. The table is easily sorted by clicking on any column header. The dictionary results panel can also be customized and sorted.
  • Suggestions: Coder provides coding Suggestions based on coding properties for dictionary records.
  • Third-Party Coding Suggestions: Coder allows you to select from curated third-party suggestions.
  • Verbatim Search: Coder allows you to search for verbatims in the WHODrug or MedDRA dictionaries.
  • Seamless Integration with EDC: Code Requests are generated at form submission from EDC. When a form change in EDC has affected a core Code Request property, Coder will clear any assigned codes for impacted Code Requests, and change their status to Updated
  • Basic Coding Report Export: Reports can be generated by study. All metrics for WHODrug and MedDRA forms in the study are included in the report. Reports can be exported to CSV format.
  • Progress Metrics: The summary page displays high level metrics to show progress and help prioritization.
  • Dictionaries Supported: In the current release, Vault Coder supports English-language and Japanese-language dictionaries, including MedDRA 20.0+ (English), MedDRA/J (Japanese), WHODrug B3 and C3 versions (English), and JDrug (Japanese).
  • Dictionary Upversioning: Coder allows you to upversion the dictionaries used in the application to more recent releases.
  • Batch Upversioning: You can upversion multiple Synonym Lists and their forms at once.

Getting Started

Check out the help topics listed here to learn about how to use Vault Coder and get started.