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Subject management

A subject is a healthy volunteer or a patient enrolled to participate in the clinical trial according to criteria defined in the study protocol. The management of subjects can occur in two different eClinical applications: EDC or IWRS depending on the system configuration.

Important

To be able to register and handle subject interaction from IWRS, the Managing Subjects value must be set to In IWRS in the ADMIN application.

Once you configure to manage subjects in IWRS for your study, a variety of features becomes available. You can view detailed information on each subject, handle randomization, and track the dispensation of treatment drugs for each subject.

To quickly filter or navigate to the subject you want to view or manage, you can use the site code filter given in the workspace toolbar. By default, the first site code filter in the list is selected displaying the subjects registered at the respective site. You can switch between the sites or hide the sites you do not want to see on the list.

Site code filter elements
Figure 1. Site code filter elements

Detailed information on the subjects and the possible options can be found in the following table.

Subject list
Figure 2. Subject list

Column

Details

Site Code

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

[Unique ID Label]

Represents a unique identifier assigned to a subject. Selecting the unique ID value navigates you to the respective subject's details, such as:

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

Randomization Approved

Represents an option to approve or withdraw the subject randomization. This column is available only if the Randomization Approval Required option has been enabled.

Randomization ID

Represents the randomization number assigned to the subject. However, if the study does not use randomization or the subject is not randomized, then the randomization ID is not assigned.

Initial

Indicates whether the status of the subject is initial.

Arm Name

Represents the arm to which the subject is allocated. This is a blinded property so you can see information here only with proper blinding permissions.

Cohort Name

Represents the name of the cohort to which the subject belongs.

The column is only available if it is enabled from the Study Information setting.

[Subject-specific factor]

Represent the columns named following the configured factors of the subject-specific treatment factor range, that are set to be displayed in reports. There can be as many such columns as configured factors.

The names of such factors can be customized upon configuration. However, if the same factor is used as a randomization factor for a subject (period factor), its original name is displayed in the table instead of a custom alias.

For instance, if the subject's age and sex are configured as subject-specific factors in IWRS, two columns named "Age" and "Sex" are available in the table.

Status

Represents the current status of a subject.

Disposition Date

Represents the date and time according to the timezone of the site where the subject has been randomized.

Unblind Request Status

Represents the status of the unblinding request if one has been submitted for a specific subject.

Unblinded

Indicates whether the subject is blinded or unblinded.

Current Phase

Represents the current study phase of the subject that is populated from the EDC application or from IWRS when the subject phase is updated. If the subject is discontinued, then this column displays the subject phase as Discontinued.
See also
In this section:

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.

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, a process of providing a subject with medication at a visit to a site during their treatment in the course of a clinical trial.

A group of subjects formed as a result of randomization for blinding purposes that has its own schedule of visits and treatment plan according to a study protocol.

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.

sitesEDCEDC