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Activate/Inactivate 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 with either Active or Inactive status, you can always change this status to reflect the current state of the study within the eClinical platform. This allows for dynamic adjustments based on the accurate representation of the study's actuality at any given point in time.

Important

eClinical studies can be managed and sustained only when active. If a study becomes inactive, it is not available within the system.

To activate or inactivate a study

  1. In the ADMIN application header, select the HIERARCHIES tab.

  2. In the left pane of the page that opens, select the needed sponsor icon_sponsor_level.png.

    Selecting sponsor
    Figure 1. Selecting sponsor

  3. In the table that appears, next to the inactive study, select Activate activate_icon.png to enable it. Or, next to the active study, select Inactivate inactivate_icon.png to deactivate it.

    Selecting to activate/inactivate study
    Figure 2. Selecting to activate/inactivate study

Once selected, the study is activated or inactivated based on the action performed.

In this section:

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.