Medical Coding Module

The Medical Coding Module is a component of the TrialStat EDC platform, designed to support medical coding workflows in clinical trials. It handles the coding of verbatim terms sourced from both the TrialStat EDC system and external data sources, and is intended for use by coding specialists working across clinical research programs.

The module, referred to as "Coder," integrates with TrialStat's broader EDC environment and supports standard medical dictionaries including MedDRA and WHODrug. It is built to reduce manual coding effort, maintain consistency across studies, and support regulatory alignment through up-to-date terminology standards.

Core Coding Capabilities

• Provides accurate coding of medical terms using advanced algorithms and comprehensive dictionaries, with the aim of minimizing errors and maintaining data integrity.
• Generates coding suggestions based on context and previous coding decisions to reduce the time and effort required from coding specialists.
• Integrates regularly updated versions of MedDRA and WHODrug dictionaries to keep studies aligned with current industry standards and regulatory requirements.

Synonym and Dictionary Management

• Includes a synonym list feature that allows coding specialists to record decisions for frequently encountered terms, enabling automatic coding of similar terms in future instances to improve consistency and efficiency.
• Supports upload of new dictionary versions from sources such as MedDRA and WHODrug.
• Provides a self-service module that allows coding specialists to perform synonym migration, impact analysis, and study up-versioning without requiring programming expertise.

Query and External Data Management

• Consolidates coding queries raised by specialists and makes them accessible directly within the TrialStat EDC system, supporting communication between coding specialists and site personnel and facilitating resolution of discrepancies.
• Supports importation, coding, and extraction of verbatim terms from external sources, allowing consistent coding decisions to be applied across clinical programs, including trials managed outside of the TrialStat EDC.

The Medical Coding Module is part of the TrialStat EDC suite, which also includes eConsent, ePRO/eCOA, Randomization/IWRS, Pharmacovigilance management, and Regulatory Compliance features. TrialStat also offers supporting services such as study design and configuration, project management, end user training, and randomization and supply management.