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Analyze data quality report for eCOA and eDiary

The data quality report of EDC helps you analyze the statistics of data collection via the eCOA and eDiary mobile applications. This report provides a visual and structured analysis of missing data, open queries, and modifications. These statistics help you assess data inconsistencies, outline issues and trends of data collection, thus finding solutions for potential or existing risks.

Tip

The data you see in the report depends on the site access permission provided to you via the ADMIN app.

To analyze the data quality report for eCOA and eDiary

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

  2. From the left pane of the page that opens, select eCOA and eDiary Report > Data Quality Report.

    Accessing data quality report
    Figure 1. Accessing data quality report

  3. On the Missing Data Points page, from the dropdown menu, select the app for which you want to view the statistics—eCOA or eDiary.

    Selecting app for data quality report
    Figure 2. Selecting app for data quality report

  4. Now select the needed report view—chart or table—and analyze the statistics as follows.

You have analyzed the data quality report. You can also export the report for offline access if needed.

In this section:

An eClinical mobile application designed for the collection of clinical outcome assessments, such as patient-reported outcomes, questionnaires, and other data related to the participant's health, symptoms, or treatment experiences.

An eClinical mobile application used for the collection and management of clinical data of subjects, supporting iOS and Android systems. It is based on the electronic CRF provided by the Study Designer application to support subjects' self-recording of treatment and diagnosis information.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

In eClinical, queries are created to ask a question or get feedback from a designated system user on a particular data item. There are two types of queries in the system:

  • Manual query: these are created by the system users and assigned to responsible users to address the issues and either correct them or confirm the data's accuracy.

  • System query: these are generated automatically by the system and require user interaction to manage and resolve them.

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.

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."