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View SAE report

SAE report comprises information related to the adverse event (AE) and serious adverse event (SAE) occurrences during a clinical trial. This information is pulled from the SAE forms completed under the DATA ENTRY tab of the EDC application. Having the full SAE report is vital for the FDA approval process.

To view the SAE report

  1. In the EDC application header, select the STUDY INFO tab.

  2. On the page that opens, in the left pane, select the SAE > SAE Report subtab.

    Accessing SAE report
    Figure 1. Accessing SAE report

  3. On the SAE Report page that opens, in the filter block at the top, select the preferred options to generate the report according to your current business needs. You can find the description of the available search options in the following table.

    Selecting SAE report search parameters
    Figure 2. Selecting SAE report search parameters

    Element

    Details

    Site Code

    Select the site code to view the report on all adverse event records for subjects registered at that site.

    Subject ID

    Select the subject ID to view the report on the adverse event records for that subject.

    If before selecting the subject ID you have already specified the site code filter, the dropdown list only includes the subjects registered at that site. If no site code has been selected, the list has all the subjects of your study.

    AE#

    Enter the number of the adverse event form in the EDC system to search for a specific form and its related records.

    AESER

    Select one of the following:

    • Yes: search for the adverse event forms in which the occurrence is stated as SAE.

    • No: search for the adverse event forms in which the occurrence is stated as not serious.

      This becomes helpful for the SAE records that were inactivated when the adverse event was reinstated as not serious. However, the inactive SAE records are still traceable in this report for compliance.

    Report Type

    Select the type of the SAE record:

    • Initial: search for the first records of the SAEs.

    • Follow-up: search for the follow-up records of the SAEs.

    If before selecting the report type you have already selected a site code/subject ID, the report only includes the initial or follow-up data on the SAE(s) of that site/subject. If no site/subject has been selected, the report includes all the initial/follow-up SAE records of your study.

    Status

    Select the status of the SAE record:

    • Initial: search for the records whose completion was initiated under the DATA ENTRY tab but not yet submitted.

    • Completed: search for the records that were completed with data and submitted under the DATA ENTRY tab.

    • Signed: search for the completed records that were already signed by the personnel in charge of AE/SAE validation.

    SAE Active

    Select one of the following:

    • Yes: search for the SAE records that are active in the EDC system.

    • No: search the SAE records that are inactivated in the EDC system.

    AE Active

    Select one of the following:

    • Yes: search for the AE forms that are active in the EDC system.

    • No: search the AE forms that are inactivated in the EDC system.

    Report Date

    Select the start and end date to view the report on adverse events recorded within the specific period.

    If prior to selecting the dates you have already selected a site code/subject ID, the report only includes the SAE data of that site/subject. If no site/subject has been selected, the report includes all the SAE records of your study within the specified period.

    Data Change Date

    Select the start and end date to view the report on adverse events records that have been updated within the specific period.

    If prior to selecting the dates you have already selected a site code/subject ID, the report only includes the SAE data of that site/subject. If no site/subject has been selected, the report includes all the updated SAE records of your study within the specified period.

    Search

    Select Search_button_red_01.png to apply the selected filtering and generate the report.

    Clear

    Select clear_button.png to clear all the selected filtering and start over.

  4. In the resulting report, switch between the tabs to view the details on the AEs, SAEs, and all the related forms data.

    Reviewing SAE reports
    Figure 3. Reviewing SAE reports

You have studied the details of the AE-related forms in EDC.

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.

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.

A national regulatory agency that controls the development of new drugs and standards compliance by clinical trial researchers.

Learn more about FDA on the official website.