The topics below will help Coding Administrators, and users in similar roles, get started using Vault Coder:
The Vault Coder application allows you to ensure pharmacovigilance in a clinical study by standardizing clinical data and reveals statistically significant occurrences of adverse events and the use of concomitant medication to prevent or mitigate the adverse events.
Vault Coder can store a record of previously coded Code Requests called a Synonym List. Coder uses the Synonym List to autocode. During autocoding, Vault Coder evaluates pending Code Requests and compares their coding properties to Synonyms in the Synonym List. If there is an exact match between the code request’s properties and the patterns stored within the Synonym List, Vault Coder automatically assigns the corresponding code to the Code Request. If there is no match, Vault Coder attempts to autocode from the assigned coding dictionary release (when configured). Autocoding drastically reduces workload for clinical coders.
Once you open a coding Form, Vault Coder opens the Code Request Listing table for that Form, which lists all existing Code Requests associated with that form. From here, you can then narrow down the list of Code Requests, view details about Code Requests, as well as assign codes.
The table below defines each Coding Status for Code Requests. The Label column shows how each status displays in the Coding Status column of the Code Request list.
Vault includes several reports with operational coding data for your review within the Reports tab.
From the Code Request Listing page, you can assign codes to Code Requests, uncode Code Requests, or autoassign Code Requests.
If you coded a Code Request in a non-traditional way and you would like to provide an explanation for your coding choice, you can attach a note to the Code Request using the Notes card.
You can use queries in Vault Coder to communicate directly with sites. This is helpful if you need more information from the site in order to code a Code Request.
You can search your form’s coding dictionary from the Coding panel’s Dictionary Search field. In the search results, Vault lists the preferred name variations for a Drug Name. In the image below, a user searched for “Lidocaine”, which yielded codes with the preferred Drug Name “Lidocaine” at the top of the results.
The Coding panel is where Vault Coder shows coding suggestions for Code Requests and where you can search the coding dictionary for terms to code to.
Vault Coder leverages the Vault Platform to provide dashboard capabilities for operational metrics. Veeva provides a standard dashboard that you can use to view operational data, or to use as a template to copy to configure your own.
The Vault Coder application consists of two main pages: the Summary page and the Listing page.
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.
You can schedule an Autocoding and Suggestions job to run the autocoding and suggestions algorithms daily, weekly, or monthly, or you can run it immediately. This job analyzes all Code Requests that are pending coding and attempts to autocode them and generate suggestions. The Autocoding and Suggestions job is helpful if you are new to using Vault Coder, and you have just begun building a Synonym List, but you want to autocode and provide suggestions for older Code Requests that were created before the matching patterns were available in your Synonym List.
Coder users with EDC Tools permissions can initiate a Code Request Export job to export a CSV file detailing all Code Requests. Users can choose to export that file to an FTP destination, or simply download the file when the job is complete.
Coder Tools > Study Settings includes a Form Configuration section, which lists the Forms collecting coding data within the selected Study. From here, you can assign Synonym Lists and Stop Lists to a Form, enable dictionary-specific fields, and upversion to a new dictionary release.
There are various settings that control available functionality, such as Synonym List review and autocoding scope, within Vault Coder that you can manage from Coder Tools. Vault Coder includes application-level settings, which Vault uses as a “template” and applies to new Studies. You can customize these from Coder Tools > Application Settings.
When you want to prevent a certain Verbatim from being autocoded, you can add that Verbatim to a Stop List. When a Verbatim is on a Stop List, Vault Coder does not include any Code Requests that match that Verbatim in autocoding.
Vault Coder uses Synonym Lists to inform autocoding. When autocoding, Vault compares pending Code Requests to Synonyms in the form’s Synonym List. If Vault finds a match between the pending request’s properties and a Synonym, Vault autocodes the request and assigns the code from the Synonym. You can manage the available Synonym Lists in your vault, including creating new Synonym Lists and upversioning existing Synonym Lists, from Coder Tools > Synonym Lists. From here, you can also review and either approve or reject new Synonyms for a Synonym List as coders request to add them.
Once a new WHODrug or MedDRA dictionary release is available, you can upversion a Form and the form’s assigned Synonym List to reference that new dictionary version. Upversioning a Form itself and the Synonym List that the Form uses are separate actions, but both are required to update the Form.
Vault Coder includes a specialized administration area within Tools > Coder Tools. From Coder Tools, you can perform administration tasks related to coding activities in your vault, such as managing application- and study-level settings, creating synonym lists and stop lists, and form configuration. Performing these tasks in a single location saves you time. Note that tasks in this area apply at the vault and study level, except for form configuration.
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.
Welcome to Vault CDMS Help! The topics below can help you get started using Vault Coder’s robust clinical data capture capabilities.