Veeva Coder Overview

Veeva Coder is a tool for the medical coding of terminology used in clinical trials. Veeva Coder is native to CDMS and transfers casebook data and coding queries in real time, with no reconciliation necessary.

Veeva Coder offers dictionary support for WHODrug, JDrug, MedDRA, and MedDRAJ, to define clinical codes for concomitant medications, adverse events, medical history, and more. The following dictionaries are supported:

  • 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.

Veeva Coder conducts verbatim searches in the supported dictionaries and lists the search results. Veeva Coder also lets you view the details and code associated with a drug or condition in order to assign codes to Code Requests.

You can build or import Synonym Lists, which are lists of previously coded verbatims and their properties, to use within your study. You can also add to the Synonym List while coding. New additions will either be autocoded to Code Requests with matching Verbatims automatically, or will be autocoded after being approved by a Coder Administrator. Coding Suggestions are generated from the records in the Synonym List assigned to the Form.

When a Synonym List has been added to a study and assigned to a Form, Veeva Coder can use that list for autocoding. During autocoding, Veeva Coder looks for matches between pending Code Requests and Verbatims within the Synonym List. If it finds a match, it autocodes the pending Code Request to the same code found in the Synonym List.

Features

Veeva Coder provides several features that improve coding efficiency:

  • 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. Learn more about configuring Forms for Coding.

  • Synonym Lists: Coder allows you to create and add to Synonym Lists, which contain previously coded verbatims and their properties. Synonym Lists are used to Autocode. Learn more about Synonym Lists.

  • Autocoding: An automated feature which assigns a code based on a comparison between the coding properties of pending Code Requests and a Synonym List, or based on exact dictionary matches if no Synonym List match is found. Learn more about autocoding.

  • Suggestions: Coder provides coding Suggestions based on records in the assigned Synonym List. Learn more about coding Suggestions.

  • External Coding Suggestions: Coder allows you to select from curated external Suggestions. Learn more about external Suggestions.

  • Batch Coding: Select multiple Code Requests and assign them the same code with one click. Learn more about Batch Coding.

  • Code + Next: Click Code + Next to quickly assign a code to a Code Request and automatically move to the next pending Code Request. Learn more about assigning codes to code requests.

  • Queries: Clinical coders can use queries 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. Learn more about queries.

  • 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. Learn more about Notes.

  • Status Filter: Filters Code Requests by their Status: Open, Autocoded, Uncoded, Noncurrent, Coded, Pending Approval, Rejected, and Updated. Learn more about filtering Code Requests.

  • Query Filter: Filters Code Requests by Query Status: Query to Site, Site Responded, Re-Queried Site, Closed, and None. Learn more about filtering Code Requests.

  • Sorting: Code Requests are listed in a table. Some columns in the table are sortable. The Coder panel can also be customized and sorted. Learn more about sorting and filtering Code Requests.

  • Verbatim Search: Coder allows you to search for verbatims in the assigned WHODrug or MedDRA dictionaries. Learn more about searching dictionaries.

  • Coding Request 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. Learn more about the Code Request Export job.

  • Progress Metrics: The Summary page displays high level metrics to show progress and help prioritization. Learn more about the metrics displayed on the Summary page.

  • 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 Versioning: Vault Coder allows you to change the version of the dictionary associated with forms. Learn more about dictionary versioning.

  • Batch Upversioning: You can upversion multiple Synonym Lists and their forms at once. Learn more about batch upversioning.

  • Remapping in Versioning: During dictionary versioning, the system can automatically check whether verbatims and Synonyms exist in the new dictionary version, and if the full assigned code does not exist in the new dictionary release, then the system will attempt to remap the code. Learn more about dictionary versioning.

  • Batch Assign Lists: Assign a Synonym List to multiple forms at once. Learn more about Batch Assign Lists.

Getting Started

Learn more about how to get started using Veeva Coder here.