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Configure study arm

In PV, the basic information about the study, like its name, timeframe, and such, is automatically pulled from the CTMS application. Nevertheless, there are some manually configurable details. Namely, from the Study Setting tab, you can configure study arms to help you diversify between groups of patients and their treatment plans.

You can configure a new study arm from scratch or by copying the existing arm. This section concentrates on how you can add a new arm from scratch.

Tip

You can switch between different studies directly from the configuration page with no need to return to the Study Setting table. Simply expand the menu from the toolbar and select the study of your interest.

Switching between study configurations
Figure 1. Switching between study configurations

To configure a new study arm from scratch

  1. In the PV application header, select the CONFIGURATION tab.

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

    Accessing study setting
    Figure 2. Accessing study setting

  3. On the Study Setting page that opens, from the Study Name column, select a particular study.

    Important

    The list of studies available here depends on the study access permissions granted to your user group via the ADMIN application.

    Selecting study
    Figure 3. Selecting study

  4. On the page that opens, in the Study Arms block, select New plus_icon_gray.png.

    Selecting New in Study Arm table
    Figure 4. Selecting New in Study Arm table

  5. On the Study Arm table, fill in all the details as explained in the following table.

    Viewing Study Arm table
    Figure 5. Viewing Study Arm table

    Tip

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

    Element

    Details

    Arm Name*

    Enter the name of the study arm.

    Blind Type*

    Select the blinding type (Open Label, Single Blind, Double Blind, or Triple Blind).

    Primary License

    Select the primary license from the list of available ones.

    The primary license can only be selected after you add study arm products.

    If the study arm is blinded (Single Blind, Double Blind, and Triple Blind), and also contains an unblinded product, you can only select a blinded product license as the primary license.

    SAVE

    Select save_icon.png to save changes and create the new study arm.

Once saved, the new study arm is configured. You can now configure a study product for this arm.

In this section:

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.

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.

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.