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 the Oracle Health Sciences Support.

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. Navigate to Oracle Health Sciences Support, at https://hsgbu.custhelp.com/.
2. Click Login, and enter your credentials.
3. Click My Requests.
4. In the upper left side of the screen, click Change Requests.
5. In the upper right side of the screen, click Create a new Change Request.
6. In the Application Install/Change/Re-setup/Uninstall tile, click Create a Request.
7. From the Category drop-down, select Change - Cloud Environment > Application > Setup, and then click OK.
8. 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.
9. In the Select Product drop-down, select Argus Safety, and click OK.
10. In the Business Service drop-down, select the name of the server where you want the dictionary recode to be performed, and click OK.
11. In the Action drop-down, select Other, and click OK.
12. From the Oracle Internal radio buttons, select No.
13. In the Environment drop-down, 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. Select the appropriate values from the Severity and Implementation Window drop-downs.

    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.
17. In the Date Required By field, select a value from the calendar.
18. 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.