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Generate domain delta change report

The Domain Delta Change report is a valuable tool for comparing verbatim term (VT) coding results across different batches or datasets within the same coding domain. This report highlights any changes or inconsistencies in coding assignments, helping you assess the consistency and accuracy of coding over time or across similar datasets.

By generating this report, you can:

  • Identify discrepancies in coding outcomes between batches or datasets.

  • Evaluate the impact of updates to the synonym list or manual coding decisions.

  • Ensure consistency in coding practices across similar data domains.

To generate a domain delta change report

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

    Accessing reporting functionality
    Figure 1. Accessing reporting functionality

  2. On the page that opens, in the left pane, select Domain Delta Change.

    Accessing domain delta change reporting functionality
    Figure 2. Accessing domain delta change reporting functionality

  3. On the Domain Delta Change page, customize the data for comparison as explained in the following table.

    Preparing domain delta change report

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Parameter

    Details

    Main Batch*

    Select the primary batch of verbatim terms (VTs) that serves as the baseline for comparison. This batch contains the coding results you want to evaluate against another dataset.

    Compare With*

    Choose the secondary batch to compare against the main batch. This helps you identify any differences in coding outcomes between the two datasets.

    Domain*

    Specify the coding domain, (for example, AE) relevant to the report. This ensures that only VTs from the selected domain are included in the comparison.

    Dictionary Type*

    Define the type of dictionary (MedDRA or WHODrug) used for coding. This helps to ensure accurate mapping and comparison of terms based on the dictionary standards.

    Report Header*

    Select how the report headers should display information:

    • Show Name: displays only the verbatim term (VT) names in the report header.

    • Show Label: displays only the VT descriptions (labels).

    • Show Name and Label: displays both the VT names and their descriptions.
    Figure 3. Preparing domain delta change report

  4. Select Key Setting to customize the parameters for your report.

    Customizing report parameters
    Figure 4. Customizing report parameters

  5. In the Key Setting dialog that opens, define the context of the data being compared as explained in the following table.

    Defining data to compare
    Figure 5. Defining data to compare

    Element

    Details

    Study Name

    Specify the study to which the report relates.

    Site

    Select the site to be included in the report data.

    Subject

    This field is preselected and inactive, automatically including data for the selected subject only.

    Visit

    Specify a visit to ensure the report focuses on data from that specific visit.

    Form

    Select a form to include data captured in that particular form.

    Line

    This field is preselected and inactive, showing the specific data entry line in the Case Report Form (CRF) where the main variable is located.

    MainVariable

    This field is preselected and inactive, indicating the primary variable that the report analyzes.

    Indication

    Specify the indication to include data relevant to a specific medical condition or symptom.

    Route

    Define the route (administration method) to focus the report on terms associated with that route.

    SAVE

    Select SAVE-button.jpg to create the new report.

    CANCEL

    Select CANCEL-button.jpg to cancel the report generation and dismiss any changes made.

  6. In the upper-right corner, select GENERATE REPORT.

    Generating domain delta change report
    Figure 6. Generating domain delta change report

Once done, the generated report appears in the History table. The newest report is always displayed at the top of the list for easy access. You can download the report in an XLSX format to analyze the results, compare data, and assess changes based on the selected parameters.

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.

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 specific area or category of data within a clinical trial that encompasses a set of related variables that share a common theme. Each domain organizes data to facilitate analysis and reporting, ensuring that information is structured and easily interpretable.

For example, in a clinical trial, domains might include demographics, efficacy, safety, and laboratory results.

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.

study

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.

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

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.

form