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Configure unique ID parameters

In clinical trials, unique identifiers (IDs) are used to distinguish trial participants. Unique IDs are intended for the protection of personal information and confidentiality. Using IDs can facilitate data integrity, blinding, randomization, monitoring, analysis, and other purposes in the course of a clinical trial.

A unique ID is configured in EDC and is automatically assigned to each subject registered in the system. In IWRS, you can specify the elements of the unique ID, whether the ID can be edited, and so on. Depending on the sponsor's requirements, there can be multiple IDs as the subject passes through different study phases. Additional subject identifiers are configured in EDC but they do not affect subject registration and management in IWRS.

To configure unique ID parameters

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. On the page that opens, in the left pane, select the Study Information subtab.

    Accessing study configurations
    Figure 1. Accessing study configurations

  3. From the Study Information contents panel, select the ID Configuration tab.

  4. In the form that opens, configure unique ID parameters as explained in the following table.

    Configuring unique ID parameters
    Figure 2. Configuring unique ID parameters

    Element

    Details

    Unique ID Configuration

    Auto Unique ID

    Configure as follows:

    • Turn on this toggle to automatically assign a unique ID when registering a new subject in the system.

    • Turn off this toggle if you want the system users to enter unique ID manually when registering subjects in the system.

    Edit Unique ID

    Configure as follows:

    • Turn on this toggle to allow system users to edit the unique ID when registering new subjects (applicable to autogenerated unique ID) or editing subject details.

    • Turn off this toggle to prohibit the unique ID editing when registering new subjects (applicable to autogenerated unique ID) or editing subject details.

    Unique ID Elements*

    Select add_new_icon_01.png to choose the elements that are to compose a unique ID for a subject. You can drag nodes to change their order. Available options are as follows: Site Code, Number Range (asc), Letter Range (asc), and Dash.

    For example, if you have selected Site Code - 01-99 where Site code = 001, then your unique ID is generated in the range of 001-01 - 001-99.

    This setting is only available if Auto Unique ID toggle is turned on.

    Unique ID Label*

    Enter the name of the unique ID displayed and recorded in the IWRS and EDC systems—in subject lists, reports, dispensation records, and so on. ID customization suits the business needs of different clients that may use "Subject ID," "Patient ID," or else in their studies to identify subjects.

    SAVE

    Select save_button_red.png to save the implemented changes.

Once saved, the unique ID configuration is applied.

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.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.