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Configure study reference by type

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 a study reference by type. The essential details of the study configured here, such as the registration information or else, are then referenced by the system when submitting cases pertinent to the study to authorities.

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 study reference by type

  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 appears, in the Study References block, select New add_new_icon.png.

    Selecting to add new study reference
    Figure 4. Selecting to add new study reference

  5. In the New dialog that appears, provide the data as explained in the following table.

    Configuring study reference by type
    Figure 5. Configuring study reference by type

    Tip

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

    Element

    Details

    Type*

    Select the type of the study reference being added.

    Country*

    Select the country that is assigned to the study reference being added.

    Number*

    Enter the number that is assigned to the study reference being added as per the reporting region.

    For this field, Null flavor null_flavour_icon.png is available. Select null_flavour_icon.png next to the field to activate the null flavor selection (No Information, Masked, Unknown, and so on). You can find the details for the available null flavor options and their codes in Appendix A. Null flavor specification.

    SAVE

    Select save_button_red.png to apply the changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes.

Once saved, the new study reference based on the selected type is configured.

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.