Perform a regulatory submission review of a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, enter the search criteria for a case and click Search.
3. From the search results list, click a Case ID link.
4. From the Case Form, select the Analysis tab.
5. To view differences in narratives for the case, in the Case Analysis section, click Show Difference.

   Note:

   The Show Difference button is enabled only if at least one previously locked version exists for the case.
6. To create a MedWatch 3500A Drug Report, select the MedWatch Info subtab.
   1. Enter the following details in block B:
      • If the product caused an adverse event in a patient, in Block B, select Adverse Event.
      • If a product defect or malfunction lead to the death or serious injury of a patient, select Product Problem.
      • If a malfunction or problem of the product caused the death or serious injury of a patient, select both Adverse Event and Product Problem.
   2. In block C, enter medication data in Suspect Medications.
   3. Enter the following information in block F:
      • If you selected Product Problem in block B, enter the National Drug Code in Suspect Medications (NDC#).
      • Select the option corresponding to the origin of the report – User Facility or Distributor.
      • If you don't want the MedWatch 3500A Drug Report to include information from block F, select Suppress Block F Printing.
      • Enter the report number in full as shown in the upper-right corner of the screen in UF/Dist report number.
      • Enter the details of the user facility or distributor reporting site in User facility or distributor name/address.
      • Enter the details of the contact person for medical device reporting (MDR) in Contact person.
      • Enter the date when the user facility's medical personnel or the distributor became aware that the device may have caused or contributed to the reported adverse event in Date aware of event.
      • To delete an existing FDA Patient or Device code, select the row and click Delete.
        • The Select button from Patient Problem is disabled.
        • The Add button allows you to add device problem codes and Patient Problem code fields are disabled for data entry.
        • This section only displays existing records.
        • The application allows deletion of existing codes, if required.
      • If a report was sent to the FDA, check the Report sent to FDA check box and enter the date.
      • If a report was sent to the manufacturer, select the Report sent to mfr? check box and enter the date.
   4. Enter the following information in block G:
      • Match all report sources in Reporter Type by checking the corresponding Report Source check boxes.

        Note:

        If the country of incidence isn't the US, the value Foreign appears by default.

        If the primary reported on the General tab is a health care professional, the value Health Professional appears by default.

      • Alternately, select Other and enter the necessary text.
      • Enter the PLA number in STN# Pre-1938/OTC Product.

        - If the product pre-dates 1938, select Pre-1938.

        - If the product is an over-the-counter product, select OTC product.

7. To review information about the history and the current condition of the patient and generate the BfArM 643 form, select the BfArM Info subtab.

   Note:

   If available, Oracle Argus Safety uses the relevant information from the Current Medical Status Form on the Patient tab to fill in the fields on the BfArM Info tab.
   1. Enter a causality or modify the existing value from the Causality drop-down list.
   2. Select or modify the existing values that apply to the patient from the drop-down lists in the Check One in Each Category section.
8. To assess imputability for the suspect product, select the AFSSAPS Info subtab.
   1. Check one or more check boxes in AFSSaPS Information.

      Tip:

      Check the Autres check box to enable the corresponding field.

   2. Enter a description in Future Actions.