Enter a new case

From the Initial Case Entry form, you can decide to book in a case before entering further case information in the Case Form.

To enter a new case:

  1. On the Home page, hover over the Case Actions menu and click New.
  2. On the Initial Case Entry page, enter the mandatory information (fields with a red flag) and click Continue.
  3. Click Search to confirm this is not a duplicate case.
  4. A list of cases that match the criteria you entered on the form is displayed. Review the search results for a duplicate case.
    If a duplicate case exists, open the case to enter further information related to the existing case. Click the link associated with the case.
  5. If a duplicate case does not appear, click Continue in the Initial Case Entry form to display the BookIn and Attachments and References sections.
    When a duplicate search is performed, the system remembers the results until the user logs out of the system or performs a duplicate search again. When the Bookin screen is opened, the search results from the last search are displayed again.
  6. Enter the relevant information in the following sections:
    • Under Reported Causality, select the reporter's assessment of causality. The causality relationship is the causal relationship between the clinically most important event and the suspect drug that is entered in the Initial Case Entry form.
    • For Seriousness Criteria, check the appropriate checkboxes to indicate the seriousness of the case, as appropriate.
    • Attachments and References
    To insert a file attachment
    1. Click Add on the Attachments and References tab.
    2. Enter the Classification and Description, as applicable. Select File Attachment from the drop-down list and click Add.
    3. On the File Attachment -Web page dialog box, double-click Browse and navigate to the relevant file. Click OK.
      Contact your system administrator to configure this location.
    To insert a URL Reference
    1. Select URL Reference from the drop-down list.
    2. Enter the URL after http://.
    To search for and insert a document
    1. Select Documentum Link and click Add.
    2. The Document Lookup dialog box is displayed.
      You can search for a document from the database by specifying a search criterion in this dialog box.
  7. Click BookIn.
    Once clicked, this button is hidden from the screen. The button is enabled only if the Save operation fails or when the case is booked-in successfully.
  8. If the application has been configured to generate a case number automatically, it is generated now.
    If the case number is not automatically generated, enter it according to your company guidelines.
  9. When the case creation message appears, click Yes.

    Note:

    If you click Yes, the Case Form page appears. You can now enter case data.

    If you click No, the case is saved and closed. You can open the case and enter data at any time.