Specify the MedDRA version for each time period in an Oracle Argus Mart data configuration

You must specify the MedDRA version used for each time period in the data. A time period is a range of dates during which only one MedDRA version was used to code the data.

For example, suppose that the Oracle Argus Mart data includes the following rows:

Case ID	Start	Stop
100	01-01-2004	06-01-2004
200	06-01-2004	01-01-2005
300	01-01-2005	-

Additionally, suppose that different versions of MedDRA were used to code the Oracle Argus Mart data:

• MedDRA version 6.1 was used until June 1, 2004.
• MedDRA version 7.0 was used between June 1, 2004 and January 1, 2005.
• MedDRA version 7.1 was used starting January 1, 2005.

You would specify the version of MedDRA used for each time period as described in this procedure.

1. In a Web browser, navigate to the Oracle Empirica Signal login page.
2. In the Oracle Empirica Signal application, in the navigation pane on the left, click the Settings icon ( ).
3. From the Configure System section, click Manage Configurations.
4. Click the Oracle Argus Mart data configuration's Row Action menu (), and then click Edit.

   The Modify Configuration page appears.

5. On the top table, click Edit in the far right column for the data configuration.
6. On the Edit Configuration Details page, from the Event Hierarchy Version Table field, click Select/Edit Table.

   The Event Hierarchy Accounts for Configuration window appears.

7. To specify only one MedDRA version for all of the Oracle Argus Mart data, enter the Oracle Empirica Signal database account name for the MedDRA version in the first row of the Hierarchy Account column, for example:
   
8. To specify a different MedDRA version for each time period in the Oracle Argus Mart data:
   1. In the first row of the Date column, enter the last date of the earliest time period.

      The date must be in mm / dd / yyyy format.

      Note:

      Each date includes a time stamp of 12:00:00 a.m. unless you specify a time stamp. For example, if you specify that MedDRA version 6.1 was used until (<=) 06/01/2004 and MedDRA version 7.0 was used thereafter, then MedDRA 7.0 is applied to source data coded at 12:00:01 a.m. on June 1, 2004.
   2. In the first row of the Hierarchy Account column, enter the MedDRA account name.
   3. Fill in one row for each time period in the Oracle Argus Mart data, for example:
      

      If you need additional rows, you can select Add additional empty rows upon saving, and click Save.

      For the last time period, enter only the Oracle database account name for the MedDRA version.

9. Click Save.