Overview

  • Coding against MedDRA and WHO Drug (all formats)
  • Auto-coding, intelligent manual coding, review and approval
  • Coding consistency at the trial, project or organization level
  • User-loadable synonym lists
  • Integrated with TrialMaster®
    • APIs to integrate with any external EDC or safety system
  • Modern, productive user interface

Workflow

AutoEncoder is easy to use as outlined in the steps below.

Receive Verbatim Terms: A background service detects new and changed verbatim terms in the source system and automatically feeds these into the AutoEncoder. Normally this will happen within a couple of minutes.

Auto-Code: Each verbatim term is assessed against the entries in the associated dictionary version, supplemented by records of prior history matches and any pre-loaded synonym lists. The assessment can include associated “reference items”, such as the country code for a medication. If a match is found for any of the sources, a “proposed match” is assigned to the verbatim term.

Manual Code: A coding user can either accept a proposed match, or can perform a manual search. This manual search includes linguistic pattern matching. The text search can be combined with a search on any of the other dictionary columns.

Review and Approve: The coding process may be followed by independent review and approval steps. A configuration option or elevated privileges for the coder may be used to bypass this step.

Transmit Coding Results: The coding results are automatically transmitted back to the source system, where they are stored as derived items. If the coding user subsequently decides to un-code a term, the coding results are blanked out in the source system and the term is sent back to the initial auto-code step. This means that the source system and the AutoEncoder are always synchronized with each other.

User Interface

The AutoEncoder has a responsive and intuitive user interface. Every column is sortable and filterable; Similarly the user can filter on any column, including the site, patient, verbatim term and match status. The source form is shown as a hyperlink, allowing the user to click on it and, subject to authorization, view the entire source form.

Dictionary and Synonym Maintenance

The OmniComm AutoEncoder supports MedDRA and all variants of WHO Drug, including the Enhanced and Herbal versions, and formats B2, B3 and C3. The dictionaries are loaded from the standard source files supplied by the respective dictionary vendors. New versions may be loaded as they are released.

In addition, an administrator can load any number of “synonym lists” against each dictionary. For example, a synonym list can include common misspellings of standard terms. A trial can be configured to use any number of these synonym lists, in a specified order. For example, the first synonym list could be specific to the therapeutic area for the trial, while the second could be an organization-wide synonym list.

Technical Architecture

The OmniComm AutoEncoder is a cloud-based application, where users only need a web browser to gain access. The supported browsers are IE11, Edge, Chrome, Firefox and Safari. The system is multi-organization and multi-user, so a central installation can support any number of customers all sharing the same infrastructure and the same medical dictionaries. However, trial definitions and data, coding history and synonym lists are all managed within an organization, thereby providing robust security.