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Assign eClinical apps to study

A study refers to a research investigation designed to evaluate the safety, efficacy, and other relevant aspects of a medical intervention, such as a drug, device, or treatment. Studies are conducted by a sponsor to gather data and evidence to support regulatory approval and contribute to the scientific understanding of medical interventions and preventions for existing ailments.

When the necessary sponsors are added to the client's company, you can create studies for each sponsor. Once the study is created, you can associate this study with different eClinical applications in the needed lifecycles to enable study design and implementation capabilities. Access to these applications is to be provided based on the client's services purchased from EDETEK.

To assign eClinical apps to a study
  1. In the ADMIN application header, select the HIERARCHIES tab.

  2. In the left pane of the page that opens, from its toolbar, select the needed lifecycle.

    Selecting lifecycle
    Figure 1. Selecting lifecycle

    Important

    If the study is to be maintained in all lifecycles, you need to conduct the association process in all of them.

  3. In the same left pane, select the needed sponsor icon_sponsor_level.png.

    Selecting sponsor
    Figure 2. Selecting sponsor

  4. In the table that appears, next to the needed study, select More more_icon.png > Config setting_icon.png.

    Selecting study config
    Figure 3. Selecting study config

  5. In the panel that expands, select the eClinical applications to assign to the study, and then select apply_button_white_red.png.

    Assigning applications to study
    Figure 4. Assigning applications to study

Once applied, the corresponding applications are assigned to the study. The study design and implementation processes can now be maintained for this study in the eClinical platform.

Important

If you assign the Study Designer (DESIGN) application to the study, the association is preserved through all lifecycles.