Vault Coder Overview
The Vault 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 a patient’s medical history. (Concomitant medications, or “Conmeds”, are medications that a patient is taking concurrently with a trial drug.) You can also code customized forms using Vault Coder.
Clinical Codes for concomitant medications and adverse events are defined in two dictionaries which are uploaded into the vault:
- WHODrug B3 and C3 Versions – 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+ – Provides unique codes for medical conditions. The codes are used in clinical trials to code adverse effects of taking a trial drug as reported by subjects.
Vault Coder uses the WHODrug and MedDRA dictionaries to allow you to pull up drug names and medical conditions from those dictionaries, view the details and code associated with that drug or condition, and assign the related codes for forms in your study. The Vault Coder application also allows you to build synonym lists associated with terms for your study.
Once a user assigns codes to terms, the Vault Coder application can autocode within the forms in a study. In autocoding, Vault automatically assigns codes based on a comparison between an incoming code request and an established synonym list.
Vault Coder improves coding efficiency with several features:
- Batch Coding: Multiple verbatim terms can be selected and coded for simultaneously.
- Code + Next: Vault Coder provides the Code + Next feature for rapid coding. Click Code + Next to quickly code a Coding Request and automatically move to the next open Coding Request.
- Seamless Integration with EDC: Code Requests are generated at form submission from EDC. Also , when a form change in EDC has affected a core Code Request property and the Code Request has an assigned code, Vault Coder will clear the assigned code and change the Coding Request status to Updated.
- Autocode: An automated feature which assigns a code based on a comparison between a pending Code Request and a synonym list.
- Autocode Job: You can schedule jobs to run autocoding.
- Autoassign: Allows you to automatically assign the same code to code requests with matching verbatim and properties.
- Status Filter: Sorts code requests by status.
- 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.
- Synonym Lists: Vault Coder allows you to create and add to Synonym Lists. Synonym Lists are lists of verbatim terms used to autocode.
- Suggestions: Vault Coder provides coding suggestions based on previously coded items.
- Verbatim Search: Vault Coder supports exact term match.
- Dictionary Search: Search the MedDRA or WHODrug dictionaries.
- Queries: Vault Coder allows you to send and receive messages to a site, regarding a Coding Request, from within the application.
- Basic Coding Report Export: Reports can be generated by study. All metrics for ConMeds and AEs coded in the study are included in the report. Reports can be exported to Excel.
- 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-versions of the MedDRA 20.0+ and WHODrug B3 and C3 dictionaries. Veeva Services performs dictionary up-versioning.
The following topics will help you get started using Vault Coder: