Skip to main content

Analyze item data report

The Item Data report is a tool for analyzing each data input for precise items (record lines) of the EDC CRFs. It shows all the item IDs and their details, such as the site, subject, and visit for which the item has been updated, the question of the CRF to which it refers, the value recorded for it, the modification time, the user who updated the data, and more.

To analyze the item data report

  1. In the EDC application header, select the REPORTS tab.

  2. On the page that opens, in the left pane, select the Data Summary subtab to expand the list of available reports and select Item Data.

    Accessing item data report
    Figure 1. Accessing item data report

  3. In Item Listing that opens, analyze the details of item completion in EDC as explained in the following table.

    Tip

    Using the table filters feature, you can filter the report as needed, for instance, by Subject ID to view the summary of item data for the subject of your interest.

    Analyzing item data report
    Figure 2. Analyzing item data report

    Column

    Details

    ID

    Represents the system-generated unique identifier of the item.

    Site Code

    Represents the code of the site where the data entry for the item was made.

    [Unique ID Label]

    Represents the unique identifier of the subject in the study.

    The column name depends on the unique ID label configuration of your study in IWRS.

    If there are additional IDs configured for your study, you see as many such columns as there are IDs.

    Visit Name

    Represents the name of the visit at which data entry for the item was made.

    Form Name

    Represents the name of the CRF to which belongs the item.

    Record SN

    Represents the sequential number of the record in a log form to which belongs the item.

    Question

    Represents the text of the question that is the item in the CRF.

    Caption

    Represents the caption text if any is set for the item.

    Value

    Represents the value entered to answer the item's question. This value is recorded in the respective variable.

    Codelist Text

    Represents the text of the code list value chosen to answer the item's question if this is the question with multiple options available for selection.

    Domain

    Represents the domain to which the answered value is stored as variable.

    Variable

    Represents the variable that stores the answered value.

    Variable Label

    Represents the custom text used as a variable's marker.

    Modified Time

    Represents the date, time, and time zone indicator when the data was entered to the item or the item data entry was last modified.

    Modified User

    Represents the name of the user or the system entity (for instance, API sync) who made the latest data entry or modification for the item.

Once the report data is analyzed, you can leave the page or proceed with further suggested actions.

In this section:

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

See also eCRF.

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.

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

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

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."