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Code VTs manually

Coding VTs manually is a crucial step in the coding process, especially when automatic coding has been executed, but some verbatim terms (VTs) remain unmatched, ensuring all terms are properly addressed.

With manual coding, you can:

  • Assign MedDRA and WHODrug dictionary terms or synonyms directly to unmatched entries.

  • Maintain consistency and accuracy by addressing nuances that automated processes might miss.

To code VTs manually

  1. In the Medical Coding application header, select the CODING tab.

    Accessing coding functionality
    Figure 1. Accessing coding functionality

  2. On the VT List page that opens, find the VT that must be coded and, in the Verbatim Term column, select the hyperlink representing that VT.

    Selecting VT to code
    Figure 2. Selecting VT to code

    Tip

    For your convenience, filter the table to display only terms awaiting manual coding by selecting the number next to Await Manual Code in the workspace toolbar.

  3. On the Result page that opens, code the WHODrug or MedDRA term as follows.

Once you have completed the manual coding for the verbatim term, the newly assigned term appears in the Assigned Term field, and the status changes from Awaiting Manual Code to Completed, indicating that the term has been successfully coded.

The Coding Time and Coded By fields are also be populated, providing a record of when the coding was performed and by which user. This ensures that all terms are properly documented and that the coding process is tracked.

Once the coding is done, the VT is fully processed and you can now proceed with any remaining tasks or coding activities.

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.

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.

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.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

A participant who is enrolled in a clinical trial and assigned to the site.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.