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Register new subject

A subject is a healthy volunteer or a patient who has enrolled to participate in the clinical trial according to criteria defined in the study protocol. If the system configuration has been set to manage subjects in IWRS, you can only register new subjects in this application. Otherwise, the subject registration and management occur in the EDC application.

To provide the ability to register subjects in IWRS, the following preconditions must be met:

  1. In the ADMIN application, the study administrator enables subject management in IWRS, grants users permission to create subjects in IWRS, and provides them with access to study sites and depots.

  2. In the IWRS application, the study administrator enables users to register subjects to the study.

  3. Sites intended for subject registration cannot be terminated, suspended, or closed in the CTMS application, otherwise, the option to register new subjects is not available.

To register a new subject

  1. In the IWRS application header, select the SUBJECT tab.

  2. On the Subject List page that opens, from the workspace toolbar, select a site where you want to register a new subject.

    Selecting site to view subjects
    Figure 1. Selecting site to view subjects

  3. Then from the same workspace toolbar, select New Subject add_new_icon.png.

  4. In the Register Subject dialog that opens, provide subject details as explained in the following table.

    Registering subject
    Figure 2. Registering subject

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Site Code*

    A read-only field that represents a site code. It is prefilled based on the previously selected site.

    [Unique ID Label]

    Enter a unique identifier for the subject you intend to register.

    The field name depends on the unique ID label configuration of your study. The ID can be autogenerated and uneditable if configured so in ID settings.

    Initial*

    Enter the subject's initials.

    This field is available only if configured so in study settings.

    Registered Date

    Select icon_calendar.png to specify the exact date and time of subject registration.

    This field is available only if the subject phase configuration requires you to enter the date of subject registration.

    SAVE

    Select save_button_red.png to register the subject.

    CANCEL

    Select cancel_button_white_blue.png or x_icon.png to stop registering the subject.

Once saved, the subject is registered. You can now approve randomization for this subject.

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.

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

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