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Export SAE form

PV uses the data of a specific subject collected and captured in CRFs via EDC. For PV to get the data extracted from EDC, the principal investigator (PI) of a site or a designee has to create a task via the EDC > Safety Gateway functionality.

SAE report comprises information related to the SAE occurrences during a clinical trial. When a new task is created, you can export an autogenerated form in PDF format from the system. You can directly generate the report without completing an SAE form.

Important

The SAE report can be exported at any time, regardless of the current task transmission status.

To export an SAE form

  1. In the EDC application header, select the SAFETY GATEWAY tab.

  2. On the page that opens, in the left pane, select the Task Management subtab.

    Accessing task management
    Figure 1. Accessing task management

  3. On the Task List page that appears, locate the task for which you want to export the SAE form. Then access the task details in one of the following three ways:

    • For an initial or a follow-up task, select the Case ID hyperlink to open the task details page.

    • For an initial case, select View info_icon.png to open the task details page.

    • For a follow-up task, select View Differences differences_icon.png to open the task details page.

    Accessing task details
    Figure 2. Accessing task details

  4. On the page that appears, select export_sae_form_icon.png.

    Exporting SAE form
    Figure 3. Exporting SAE form

Once exported, the SAE report is downloaded to your computer and can be viewed in PDF format.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.