Specifying the version of MedDRA used for each time period in the Argus Mart data
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 Argus Mart data includes the following rows:
Sample time stamps on Argus Mart data.
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 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.
- In an Internet browser, navigate to the Empirica Signal login page.
- Log in to the Empirica Signal application as a user with the Manage Configurations user permission.
- Click Settings.
- Click Manage Configurations.
- Click the row menu for one of the Argus Mart data configurations, and select Edit.
The Modify Configuration page appears.
- In the top table, click Edit in the far right column for the data configuration.
The Edit Configuration Details page appears.
- In the Event Hierarchy Version Table field, click Select/Edit Table.
The Event Hierarchy Accounts for Configuration window appears.
- To specify only one MedDRA version for all of the Argus Mart data, type the Empirica Signal database account name for the MedDRA version in the first row of the Hierarchy Account column, for example:
- To specify a different MedDRA version for each time period in the Argus Mart data:
- In the first row of the Date column, type 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.
- In the first row of the Hierarchy Account column, type the MedDRA account name.
- Fill in one row for each time period in the 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, type only the Oracle database account name for the MedDRA version.
- In the first row of the Date column, type the last date of the earliest time period.
- Click Save.
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