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Convert a scripted AERS signal configuration to interactive (Optional)
Follow the steps in this section only if you have scripted AERS Signal Management and want to convert to interactive AERS Signal Management. After the conversion, you must no longer use the scripted AERS signal configuration.
The conversion will preserve:
- Monitored drug list.
- 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 drug and event terms.
- Reviewer assignments for drugs and drug-event combinations.
- Custom comment types.
- Comment history (both public and private) for drug-event combinations.
- Associated topics for drug-event combinations.
- Drug notes.
- Custom views for the Drug-Event Combinations page including publication status.
- 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 Drug-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 Empirica Signal application makes the distinction between "Ongoing" and "**NEW**" for subsequent refreshes.
- KUR Only events.
Interactive AERS 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 AERS 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 AERS Signal Management and the signal configuration ID of a freshly installed interactive AERS Signal Management.
When you are ready to initiate the conversion, verify that all AERS Signal Management users are logged out, and then unpublish the scripted AERS signal configuration as follows:
- Log in to the Empirica Signal application as a superuser, and click Settings.
- Click Manage Signal Configurations.
The Manage Signal Configurations page appears.
- Click the row menu for a scripted AERS signal configuration, and then click Publish.
- 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 application server.
- Navigate to the aers_ism_prep/SSM_to_ISM_update directory, for example:
$ cd /u01/stage/projects/aers_ism_prep/SSM_to_ISM_update
- Execute the following command to give execute permissions to all .sh files:
$ chmod u+x convert_SSM_to_ISM.sh
- Execute the convert_SSM_to_ISM.sh script to initiate the conversion:
$ ./convert_SSM_to_ISM.sh <signal database account name> <TNS_name> <scripted AERS ID> <interactive AERS ID>
for example:
$ ./convert_SSM_to_ISM.sh WEBVDME ORCL 0 2
A password prompt for AERS_SIGNAL_PREP appears.
- Enter <password>, where <password> is the AERS_SIGNAL_PREP account password.
A password prompt for the Empirica Signal database user account, such as WEBVDME, appears.
- Enter <password>, where <password> is the 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: AERS+SRS (S) data configuration for 2D runs, then the conversion sets the 2D data configuration in the interactive signal configuration to Latest AERS+SRS (S). If scripted Signal Management used yyyyQn: AERS+SRS (S + C), then the conversion sets the interactive signal configuration to Latest AERS+SRS (S + C).
