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Analyze AE/SAE summary details

With the Study Analytics dashboard, you can view different charts to get a quick insight into the current state of the EDC processes and data elements, such as sites, subjects' phases, opened/answered queries, and so on. In the AE/SAE Summary pie chart, you instantly get a summary of the adverse events identified and recorded in the existing subjects in the system.

If you want to view a detailed analysis of the adverse events, then using this functionality, you can get detailed information about every adverse event reported, such as the sponsor identification number, the name of the study, and the site in which the adverse event has been reported, and so on.

To analyze the adverse event summary details

  1. In the EDC application header, select the DASHBOARD tab.

  2. On the page that opens, select the Study Analytics tab.

  3. From the AE/SAE Summary pie chart, select Go Details info_icon.png.

    Selecting option to view AE/SAE summary details
    Figure 1. Selecting option to view AE/SAE summary details

  4. On the page that opens, in the AE/SAE Summary table, analyze the subject details as explained in the following table.

    AE/SAE summary details
    Figure 2. AE/SAE summary details

    Element

    Details

    Study Name

    Represents the study name in which the adverse event is reported.

    Site Code

    Represents the site code in which the adverse event is reported.

    Subject ID

    Represents the identification code of the subject for which the adverse event is reported.

    AESPID

    Represents the sponsor identification number of the reported adverse event.

    AETERM

    Represents the reported term of the adverse event, such as headache, vomiting, and so on.

    AESER

    Represents whether the reported adverse event is serious (Y) or not (N).

Once you have analyzed the adverse event details, from the workspace toolbar, select switch_icon.png to go back to the Study Analytics page.

In this section:

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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.