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Domain configuration

In the Medical Coding module, the Domain subtab provides you with an opportunity to manage and configure various domains used in the coding process. Each domain represents a specific category of medical data, for example, Adverse Events (AE domain) or Concomitant Medications (CM domain), and contains the variables and configurations needed for accurate and consistent coding.

By configuring the domains, you ensure that data captured during the study is properly categorized and coded, facilitating clear and accurate analysis.

Domain configuration page
Figure 1. Domain configuration page

For example, the AE domain might include variables, such as AETERM (the term used to describe the adverse event) and be associated with the MedDRA dictionary. Configuring this domain ensures that all adverse event terms are coded consistently according to the MedDRA standards, enhancing the accuracy and reliability of your study data.

On this page, coders have access to the following options:

  • Sync system domain sync_icon.png: synchronize the coding variable configurations of the SD application. This option is needed only for studies integrated with eClinical EDC. This ensures that the domain and variable definitions in the system match the most recent updates from SD, maintaining consistency and accuracy across domain configurations.

  • View domain details: review the details of each domain, including its name, alias, variables, last modified time, last modified by, and status.

  • Create a new domain add__new__icon__png.png: initiate the creation of a new domain. This involves defining the domain name and alias.

  • Configure an existing domain: adjust the settings of a domain to fine-tune how it functions within the coding process.

  • Edit an existing domain pencil_icon_gray.png: modify the alias name of a domain to better reflect its purpose or make it more understandable for users.

  • Activate activate_icon.png/Inactivate inactivate_icon.png: control the usage of specific domains in the coding process by activating or deactivating them as needed.

  • Delete trash__can__icon__png.png: remove outdated or unnecessary domains from the system.

In this section:

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 individual piece of data collected within a domain. It represents a specific attribute or characteristic that can vary among subjects in a study. Each variable is defined by its format (such as categorical, continuous, and so on) and plays a crucial role in data analysis, allowing researchers to assess relationships and outcomes in the study.

For instance, within the "Demographics" domain, variables might include "Age," "Gender," and "Ethnicity."

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

An eClinical application that provides functionality to design and configure a study (clinical trial), namely to configure CRFs, set subject phases, visits, and others.

The application supports the design of the CDSIC ODM-compliant electronic CRFs to support EDC and eDiary data collection and management.

Get to know all the possibilities of the app with the comprehensive SD User Guide.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.