Vault Coder Overview
The Coder application lets you code clinical forms for data on concomitant medications and the adverse events that a patient experiences from taking a trial drug, as well as a patient’s medical history. You can also create and code customized forms using Coder.
Clinical codes for concomitant medications and adverse events are defined in two dictionaries which are used within the Coder application:
- WHODrug B3 and C3 Versions – Provides 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+ – Provides 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 can be set to run Autocoding jobs. During an autocoding job, 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. Autocoding can be set to require approval for each Autocoded item.
The Coder application improves coding efficiency with several features:
- 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.
- 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.
- Autoassign: Allows you select a coded Code Request and assign the same code to any pending Code Requests with matching properties.
- 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.
- 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 the English language versions of the MedDRA 20.0+ and WHODrug B3 and C3 dictionaries.
- Dictionary Upversioning: Coder allows you to upversion the dictionaries used in the application to more recent releases.
Check out the help topics listed here to learn about how to use Vault Coder and get started.