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Application header

The application header is located at the very top of the eClinical application. It includes a set of functions that are applicable across the whole application you are working with or the eClinical platform.

Application header components
Figure 1. Application header components

For example, you can configure the time zone for your application from the application header, navigate across various tabs of the application, change your password for the eClinical platform, and so on.

The application header components may vary across different eClinical applications. However, usually, the application header of an eClinical application comprises the following components:

  • Application name: displays the name of the eClinical application, for example, EDC, IWRS, Study Designer, and so on.

    Tip

    In some applications, next to the application name, the following options are provided:

    • switch_app_icon.png: this icon provides an option to switch between certain eClinical applications.

    • Study menu just below the application name displays the name of the currently selected study and provides an option to switch between studies by selecting them from the dropdown menu.

  • Main menu: includes the tabs of that particular application.

  • General information: this block displays the following information:

    • Login: displays the username of the logged-in user.

    • Role: displays the role code of the current user, for instance, DM for data manager.

    • Time Zone: displays how all your actions are timestamped within eClinical.

  • Preferences setting_icon.png: select this icon to set the language, date and time format, and time zone preferences for all elements inside the application.

  • Application applications_squares.jpg: select this icon to access the following options:

    • Switch Application switch_application_icon.png: by selecting the option, the eClinical welcome page opens where you can choose another application to which you have access.

      eClinical welcome page
      Figure 2. eClinical welcome page

    • Change Password lock_locked.png: by selecting the option, the Change Password form opens.

    • Logout logout_icon.png: by selecting the option, you are logged out from the eClinical platform and redirected to the login page where the Login form opens.

    • Help help_icon.png: by selecting the option, the eClinical online documentation page opens in a new tab where you can search for the details on the configurations and feature business value.

      Online help documentation on eClinical applications
      Figure 3. Online help documentation on eClinical applications

In this section:

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.