Convert a scripted Vigibase signal configuration to interactive

Follow the steps in this topic only if you have scripted Vigibase Signal Management and want to convert to interactive Vigibase Signal Management. After the conversion, you must no longer use the scripted Vigibase signal configuration.

The conversion will preserve:

  • Monitored product list with product properties.
  • Keep under review (KUR) events, which are referred to as Targeted Medical Events (TMEs) in interactive Signal Management.
  • Listed (labeled) events.
  • Designated medical events.
  • Custom product and event terms.
  • Reviewer assignments for product and product-event combinations.
  • Custom comment types.
  • Comment history (both public and private) for product-event combinations.
  • Associated topics for product-event combinations.
  • Drug notes.
  • Custom views for the Product-Event Combinations page, including publication status.
  • Configured alert types.
  • Signal configuration properties including name, description, integrated topic workflow configuration and topic product field, default view, and properties for runs including the drug variable, event variables for 2D and 3D runs, stratification and subset variables, and the project for runs.
The conversion will not preserve:
  • Customizations to Drug Overviews column labels, tooltips, or to associated views.
  • Customizations to Product-Event Combinations column labels or tooltips.
  • Information that distinguishes Ongoing from **NEW** alerts.

    Following the first refresh after conversion, all alerts appear as **NEW**. The Oracle Empirica Signal application makes the distinction between Ongoing and **NEW** for subsequent refreshes.

  • KUR Only events.

    Interactive Vigibase Signal Management cannot limit the events monitored for a drug to only those that are in the Keep Under Review list. All events will be monitored.

  • Any changes not yet processed in a refresh of your scripted Vigibase Signal Management. For example, drugs to add, rename, or delete; or changes to listed (labeled), designated medical, or KUR events.

To run a conversion, you will need the signal configuration ID of the existing scripted Vigibase Signal Management and the signal configuration ID of a freshly installed interactive Vigibase Signal Management.

When you are ready to initiate the conversion, verify that all Vigibase Signal Management users are logged out, and then unpublish the scripted Vigibase signal configuration as follows:
  1. Log in to the Oracle Empirica Signal application as a superuser.
  2. In the navigation pane on the left, click Settings (Settings icon).
  3. Click the scripted Vigibase signal configuration's Row Action menu (Row Action menu icon), and then click Publish.
  4. Click Remove on each row under Publication Level.

    The text This Signal Configuration is marked as Private appears.

Perform these steps using the non-privileged user account on the aplications server.
  1. Navigate to the vigibase_ism_prep/SSM_to_ISM_update directory, for example:

    $ cd /u01/stage/projects/vigibase_ism_prep/SSM_to_ISM_update

  2. Execute the following command to give execute permissions to all .sh files:

    $ chmod u+x convert_SSM_to_ISM.sh

  3. Execute the following command to give execute permissions to all .sh files:

    $ ./convert_SSM_to_ISM.sh <signal database account name> <TNS_name> <scripted Vigibase ID> <interactive Vigibase ID>

    For example:

    $ ./convert_SSM_to_ISM.sh WEBVDME ORCL 0 2

    A password prompt for VIGIBASE_SIGNAL_PREP appears.

  4. Enter <password>, where <password> is the VIGIBASE_SIGNAL_PREP account password.

    A password prompt for the Oracle Empirica Signal database user account, such as WEBVDME, appears.

  5. Enter <password>, where <password> is the Oracle Empirica Signal database user account password.

    When the conversion is done, the message, Conversion for signal management objects completed, appears.

    The conversion.log file is created.

The conversion sets the properties for the data configuration for 2D and 3D runs to relevant aliases. For example, if scripted Signal Management used the yyyyQn: Vigibase (S) data configuration for 2D runs, then the conversion sets the 2D data configuration in the interactive signal configuration to Latest Vigibase (S). If scripted Signal Management used yyyyQn: Vigibase (S + C), then the conversion sets the interactive signal configuration to Latest Vigibase (S + C).