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 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.