Specify hierarchy versions for timestamped data

If a data configuration supports timestamped data, you must specify a hierarchy version for each time period in the source data. A time period is a range of dates during which only one hierarchy version was used to code the source data.

For example, suppose that the source 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

NA

Additionally suppose that different versions of MedDRA were used to code the source 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 on January 1, 2005.

In Oracle Empirica Signal, you must specify the version of MedDRA used to code the source data for each time period as described below.

  1. In the left navigation pane, click the Settings icon (Settings icon).
  2. In the Configure System section, click Manage Configurations.
  3. Click the Row Action menu (Row Action menu icon) for the configuration, and select Edit.
  4. In the top table, click Edit in the far right column for the data configuration.
  5. On the Edit Configuration Details page, in the Event Hierarchy Version Table field, click Select/Edit Table.
  6. To specify only one hierarchy version for all of the source data, type the Oracle database account name for the hierarchy version in the first row of the Hierarchy Account column, for example:
    Single hierarchy account for the configuration
  7. To specify different hierarchy versions:
    1. In the first row of the Date column, type the last date of the earliest time period in the source data.

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

      Note:

      Each date includes a time stamp of 12:00:00 a.m. For example, if you specify that MedDRA Version 6.1 was used until (<=) 06/01/2004 and MedDRA 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, type the Oracle database account name for the hierarchy version.
    3. Fill in one row for each time period in the source data, for example: Multiple hierarchy account for the configuration

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

      For the last time period, type only the Oracle database account name for the hierarchy version.

  8. Click Save.