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Dataset structuring

A dataset is a visual representation of columns and rows in CDASH domains based on the configuration of forms. Each column in the dataset represents a CDASH variable that captures data in corresponding rows as per record ID settings. In Study Designer, a dataset is not the actual data storage as it serves solely to show how data is structured when entered in forms of the EDC system.

Dataset structure
Figure 1. Dataset structure

You can preview the dataset for any CRF version on a separate page that can be accessed from the workspace toolbar of the hierarchy tree. To manage the dataset structure, you can perform the following actions:

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 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.

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

See also eCRF.