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Term coding

Term coding is the process of standardizing verbatim terms (VTs) from clinical trial data by mapping them to entries in standardized dictionaries, such as MedDRA and WHODrug. This ensures consistency and accuracy in the representation of medical and drug-related terms across clinical studies, enabling reliable analysis and regulatory reporting.

In practice, term coding involves matching VTs to predefined terms in these dictionaries using automated algorithms or manual input when exact matches are unavailable. This process reduces ambiguity, enhances data quality, and facilitates the integration of clinical data for regulatory submissions and safety monitoring.

The CODING tab in the Medical Coding module is the workspace where this process is executed. Here, you can interact with VTs, apply automated coding, manually assign terms, and utilize synonym lists for recurring mappings. While the CONFIGURATION and BATCH tabs serve as setup and preparation tools—defining data processing rules, creating batches, and configuring dictionaries—the CODING tab is where the actual coding process takes place. Here, you can interact with each VT, either through automated coding options or manual assignment when needed.

In this section, you will learn how to:

  • Review VTs prepared for coding: review the list of VTs that have been prepared and are ready to be coded.

  • Code VTs manually: assign a standardized dictionary term to the selected verbatim term based on MedDRA or WHODrug dictionaries.

  • Code VTs automatically: run the automatic coding process to assign terms using dictionary matches, synonyms, or other predefined configurations.

  • Clear the assigned term: remove the assigned code for a term to allow for re-coding if necessary.

  • Query for a source term: open a query for a source term if further clarification or correction is needed, particularly for terms that cannot be coded due to ambiguity or multiple interpretations (this option is available for VTs synchronized from the EDC system to the CODING application).

  • Query for coding: open a query for the already coded term if the assigned term is inappropriate. This allows the Coder to review the message and update the assigned term accordingly.

  • Delete the VT from the list: manually remove a specific VT from the list.

  • Autodelete: enable automatic deletion of terms that do not meet certain criteria.

  • Review deleted VTs: review the list of VTs that have been deleted from the VT list.

  • Restore deleted VTs: recover previously deleted VTs, adding them back to the VT list for coding or further processing.

In this section:

In Pharmacovigilance, a common term used by the AE/SAE case reporter to describe the patient's condition, symptoms, and other details. In ICSR, the verbatim terms are coded (translated) into standardized preferred terms to meet the regulatory requirements.

An internationally used set of terms relating to medical conditions, medicines, and medical devices created to assist regulators with sharing information.

A coding service that is used for the unified coding of drugs throughout the pharmaceutical industry. In order to achieve this, the service provides the WHODrug dictionary which is an international classification of medicines created by the WHO Program for International Drug Monitoring. The dictionary is managed by the Uppsala Monitoring Centre and contains drug code numbers, along with related information such as trade names, active ingredients, and additional information, such as marketing authorization, pharmaceutical forms, and strengths of the drugs.

For example, the WHODrug drug code for the substance Ibuprofen is 001092 01 001.

A collection of verbatim terms (VTs) grouped together for the purpose of medical coding. Each batch is created to streamline the coding process, allowing multiple VTs to be processed simultaneously.

In the clinical research industry, a software that is used to collect and store subject data in the clinical trial process in a permanent electronic form.

verbatim terms (VTs)