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Subject information management

In EDC, the Subject Information feature comprises the Subject List table with all subjects enrolled in a study and their details—current phase, status, and so on.

Subject information page
Figure 1. Subject information page

This page is mainly used by CRCs (clinical research coordinators) to analyze subject data and perform various actions on it.

For example, directly from the Subject List table you can activate or deactivate a subject, discontinue a subject, export subject data, drill down to the Subject data entry page where you can actually start entering clinical data for a certain subject, and many more.

The details of Subject List are explained in detail in the following table.

Column

Details

Site Code

Represents the code of the site at which the subject is registered.

[Unique ID Label]

Represents a unique ID of the subject whose clinical data is expected to be collected.

This is also an active link that navigates you to the DATA ENTRY > Visit Overview page, where you can view the visits and enter clinical data for a certain subject.

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

There might be additional IDs configured for your study subjects if the protocol requires them. For instance, there can be "Subject ID" and "Screening ID," and then two respective columns are available in the Subject List table.

Current Phase

Represents the current phase of a particular subject within a clinical trial lifecycle (for example, Enrolled, Completed, Screen Failure, and so on). The names of the phases are customizable and are initially set up in the Study Designer application.

Next Phase

Represents the next expected phase of the clinical trial lifecycle for a particular subject. Select the link to move the subject to the next phase.

CRF Version

Represents the version of the case report form that is used in the study to collect data from each participating subject.

Created by

Represents the name of the user who has created a subject in the EDC system.

Created Date

Represents the date and time of the subject creation in the EDC system.

Last Modified By

Represents the user name of a person who has made the latest updates to the subject.

Last Modified Date

Represents the date and time when the latest updates have been made to the subject.

Status

Represents the current status of the subject in the course of a clinical study:

  • Initial: the subject has just been created in the EDC system.

  • Active: the subject is actively used in the trial to collect data.

  • Inactive: the subject is inactivated and cannot be used for data collection until reactivated.
See also
In this section:

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

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.

Study Designer

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

See also eCRF.

Study Designersites