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Configure product for 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 add study arms and then configure company study products for each arm.

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 product for an arm

  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 Products block, select Add Product hierarchy_icon.png.

    Selecting Add Product
    Figure 4. Selecting Add Product

    Important

    You cannot add the same product to the arm twice.

  5. In the Add Product dialog that appears, fill in the fields as explained in the following table.

    Configuring company study product
    Figure 5. Configuring company study product

    Tip

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

    Element

    Details

    Product*

    Select the product from the dropdown list of products configured in PV. You can use search to locate your product in the list faster.

    License

    Select the license from the dropdown list of licenses configured in PV. You can use search to locate your license in the list faster.

    For a Multi-Regional Clinical Trial (MRCT), usually you do not specify the license since each country/region has its own approved license for the same product.

    Blinded*

    Select whether the product is blinded or not.

    Product Type*

    Select the type of product from the dropdown list of product types available.

    SAVE

    Select save_button_red_white.png to apply the changes.

    CANCEL

    Select cancel_button.png or x_icon.png to discard the changes.

Once saved, a new company study product is configured.

See also
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.

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.