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Assign data sheet to arm product

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.

Once the product is associated with the arm, you can also assign a data sheet to it to outline the licenses approved by specific country agencies and different data sheet revisions for the product.

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 assign a data sheet to an arm product

  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 the tab representing the drug of your interest.

    Selecting to assign data sheet
    Figure 4. Selecting to assign data sheet

  5. In the Assign Datasheet dialog that appears, complete the details as explained in the following table.

    Assigning data sheet to product
    Figure 5. Assigning data sheet to product

    Tip

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

    Element

    Details

    Trade Name*

    Select the drug trade name according to the respective data sheet.

    Datasheet

    Represents the data sheet name that belongs to the selected product. The value is populated automatically from the configured product family and cannot be manually changed here.

    Revision*

    Select the data sheet revision version that you want to be effective for the arm product.

    New Record

    Select this button to add one more row of fields and provide the additional data sheet and revision. You can add as many data sheets as needed.

    SAVE

    Select save_button_red_white.png to apply the changes.

    CANCEL

    Select cancel_button.png to discard the changes without saving.

Once saved, the data sheet is assigned to the product, and the respective indicator associated_datasheet_icon.png appears next to the product name.

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.