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Export MedWatch 3500A report

The MedWatch 3500A form is also known as the Form FDA 3500A. This form is used for mandatory adverse event reporting by IND reporters, manufacturers, distributors, importers, and user facilities personnel. Along with the follow-up investigations, this report can help to outline serious safety concerns.

With this functionality, you can export a draft MedWatch 3500A report only to check the case assessments and entries easily following the MedWatch 3500A template as we proceed with case processing and review. The exported file has the Draft watermark.

Tip

If you need the final version of the MedWatch 3500A report with no draft watermarks, it can be exported once the submission record is generated.

To export the MedWatch 3500A report

  1. In the PV application header, select the ICSR tab.

  2. From the left pane, select ICSR List.

    Accessing ICSR list
    Figure 1. Accessing ICSR list

  3. On the ICSR List page that appears, next to the needed ICSR case, select More icon_more_actions.png > MedWatch3500A Export linelisting_icon.png.

    Exporting MedWatch3500A from ICSR list
    Figure 2. Exporting MedWatch3500A from ICSR list

    Alternatively, from the ICSR List table, select the needed case number. On the ICSR details page that opens in the new browser tab, from the toolbar, select More icon_more_actions.png > MedWatch3500A Export linelisting_icon.png.

    Exporting MedWatch3500A from ICSR details
    Figure 3. Exporting MedWatch3500A from ICSR details

  4. In the MedWatch3500A dialog that appears, select one of the available FDA submission-method templates based on which report is to be generated. If there are multiple records, use the Search Submission Destination filter to facilitate your search.

    Selecting MedWatch3500A report to export
    Figure 4. Selecting MedWatch3500A report to export

    Important

    Select the Protect Confidentiality of Patient and Reporter checkbox to hide sensitive patient and reporter data in the exported report.

    Select the Blind Study Product checkbox to blind information about the study product in the exported report.

  5. Select confirm_button.png.

Upon confirmation, the MedWatch 3500A report opens in a new browser tab. You can now download it to your computer.

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.