Recode Dictionaries

Recoding does not take place automatically following a dictionary upgrade. To recode your cases with the latest dictionary, you need to create a change request ticket in HSGBU Customer Support Portal.

Note:

  • Recoding applies only to MedDRA and MedDRA J dictionaries.
  • Ensure that you have selected the latest dictionary from the Argus Console, after the Oracle team uploaded it in your environment.
  1. Log in to the HSGBU Customer Support Portal.
  2. On the upper-right side of the screen, click Switch to old portal.

    Note:

    A new Oracle Health Sciences Support Cloud portal is currently rolled out, while the old portal is still available. Until the new portal is completely functional, all the information presented in this guide about the customer support portal is referring to the old portal.
  3. On the upper-side menu, click Change Requests.
  4. Under the menu bar, on the right side of the screen, click Create a new Change Request.
  5. On the Application Install/Change/Re-setup/Uninstall tile, click Create a Request.
    The screen Submit a request to our hosting team appears.
  6. From the Category drop-down list, expand Change - Cloud Environment, then Application, and select Setup.
  7. In the Select Customer drop-down, either type the name of your company in the search field or select it from the list, and then click OK.
  8. From the Customer drop-down list, search for your company's name and select it from the list.
  9. From the Product drop-down list, select Argus Safety.
  10. In the Business Service drop-down list, select the name of the server where you want the dictionary recode to be performed.
  11. From the Action drop-down list, select Other.
  12. From the Oracle Internal radio buttons, select No.
  13. From the Environment drop-down list, select the environment where you want the dictionary recode to be performed, and make sure your selection is consistent with the value you selected in the Business Service drop-down above.
  14. In the Summary field, enter a short description of your request.

    Example: Recode <MEDDRA|MEDDRA J> dictionary in <environment> in <view-only|update> mode.

  15. In the Description field, enter a detailed description of your request, including any MedDRA recoding tool parameters, if applicable.
    You can also instruct Oracle to provide you with a log of the recode process.
  16. In the Additional Contacts field you can enter one or more email addresses to be notified about this change request, separated by a semicolon.
  17. Select the appropriate values from the Severity and Implementation Window drop-down lists.

    Note:

    • All users are expected to close the opened cases before recoding starts, to avoid any errors.
    • Usually, view-only recoding does not require downtime. However, if you don’t want users to open cases while the recoding is in progress, specify that you want the Argus application to be inaccessible during the view-only recoding process and provide the downtime information.
    • Take into account that the process of update-mode recoding requires at least four hours of downtime. For this case, plan the downtime during weekdays for the Validation and Development environments, and during weekend for the Production environment.
    • The downtime duration may vary depending on the data volume in your environment.
  18. In the Date Required By field, select a value from the calendar.
  19. Click Submit.

The cases will be updated based on the uploaded dictionary in the specified environment.

To recode your cases based on a dictionary, you need to create two change request tickets for each available environment, one for the view-only mode and one for the update mode. Therefore, for the Production, Development, and Validation environments you need to create six change request tickets in total:

  1. One change request ticket for the view-only mode recoding, where you ask Oracle to generate a file with the existing cases that will include the new coding. As a result, you will obtain a file with all the cases that will be changed. You can review the changes and make sure that the cases are properly updated.
  2. One change request for update mode recoding, where you ask Oracle to recode the cases based of the new dictionary for the specified environment. As a result, the cases will be updated based on the new dictionary in the environment.