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Start coding process

The Start Coding feature is essential for initiating the medical coding workflow after the verbatim terms (VTs) have been uploaded. This feature processes the uploaded VTs, linking them to standardized terms using predefined medical dictionaries like MedDRA and WHODrug.

By starting the coding process, you can efficiently transform raw clinical data into structured and uniform information, ensuring consistent reporting and analysis across various domains. The process helps streamline the interpretation of VTs by mapping them to relevant dictionary terms, which are then used for downstream data processing and regulatory submissions.

For example, after uploading a file containing VTs in the Adverse Events (AE) domain, such as “headache,” “nausea,” and “dizziness,” you can use the Start Coding feature to begin coding these terms. The system will match each verbatim term to standardized dictionary terms, like “Headache” or “Nausea” from the MedDRA dictionary. This ensures that all adverse events are classified consistently.

Important

The feature is available only for the domains in the Await Start status. For more details, refer to Review domains prepared for coding.

To start a coding process

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

    Accessing batch configurations
    Figure 1. Accessing batch configurations

  2. In the Batch List table that appears, go to the coding batch that contains the domain where the VTs have been previously uploaded and need to be coded. Then select upload_button_blue.png next to it.

    Accessing coding batch domains
    Figure 2. Accessing coding batch domains

  3. In the Domain List table, go to the domain containing the VTs that need to be coded. Then select Start Coding Start-coding-icon.jpg next to it.

    Initiating coding start
    Figure 3. Initiating coding start

  4. In the dialog that opens, select ok_button_white_red.png to confirm and initiate the coding process.

    Confirming coding start
    Figure 4. Confirming coding start

Once the coding process is initiated, the system begins processing the uploaded verbatim terms for the selected domain. The VTs are automatically matched against the appropriate medical dictionaries (MedDRA and WHODrug) to generate standardized coded terms.

See also
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.