Overview of topic management

To manage the process of identifying and investigating product safety issues, including organizing the collection and interpretation of information from different sources over time, you can create topics.

What are topics and actions?

A topic in Oracle Empirica Signal is a means to organize and track tables, graphs, and documents related to particular subject matter. You can collect and record issues identified through various means, such as automated signal detection, literature reviews, and regulatory requests as well as your data mining, reporting, and product-event analyses. A topic can help you and the other members of your work team track an issue throughout the process of researching and resolving it. You update the progress of the topic through different stages of work using statuses such as Initial, Reviewed, or Completed. You can monitor topics from creation to completion on the Topics tab and by using reports. You can also download all, or a selected subset, of the information stored with a topic at any time to a PDF file.

For each topic you create, you can choose a template for entering the information (if configured and made visible to a work team) and select the work teams whose members can view or act on the topic.

Within a topic you can create an action. An action is an activity that has been identified as contributing to the understanding or resolution of a topic. Examples of activities that you may track with actions include:

• Research results
• Project meetings or milestones
• Follow-up work

Like topics, actions are given workflow states to track their progress from creation to completion. An action can be assigned to the same user that is currently assigned to the topic or to a different user.

On the Topic Management page you have access to topics and actions that you created and those made visible to a work team of which you are a member.

Use topic workflow configurations to customize Oracle Empirica Topics

The title bar on the Topic Management page contains a topic workflow configuration drop-down list that shows the configurations you have access to and allows you to switch topic workflow configurations. If you have access to only one workflow configuration, Oracle Empirica Signal displays the current configuration without a drop-down list. To use Oracle Empirica Topics, you must have access to a topic workflow configuration. The topic workflow configuration defines the behavior and content of Oracle Empirica Topics.

When you create and edit topics, information is collected using a topic workflow configuration. Although a standard template is provided with Oracle Empirica Topics, it is likely that your organization has customized the topic workflow configuration to meet the specific requirements of your organization. This means that the fields shown on the pages and dialog boxes described in this guide might not exactly match the details in this guide. These customizations include:

• The fields that store information.
• The values that you can supply for each field.
• The workflow states that you can assign.
• The types of attachments you can add: Oracle Empirica Signal objects including run result tables and graphs, reports, and query results, website URLs, text notes, or files.
• The rules for sending automated email notifications triggered when a topic or action is added or modified, a change is made to its workflow state, an action due date is nearing, or the topic is assigned to a different user.

In addition, the fields that are available to store information when topics or actions are in different states, or for different types of attachments, can be set to hidden, visible, editable, or required for each defined field.

All of these attributes are stored in a topic workflow configuration that is managed by an administrator at your organization.

You can design topic workflow configurations to meet the needs of different groups in your organization. For example, a collaborative topic workflow configuration can structure the participation of several members of a work team on every topic, while a separate notebook topic workflow configuration allows individuals working in another part of your organization to track their own issues over time without the participation of other users.

Alternatively, a single topic workflow configuration allows you to work cooperatively with others on projects using topics and also track your own issues by setting up topics that you leave assigned just to yourself. If your organization defines more than one topic workflow configuration, the topics that you enter are based on just one of them. As a result, members of different groups in your organization might work with topics in different ways, supplying different types of information or assigning different workflow states.

If your organization uses the Signal Review feature, you can integrate a topic workflow configuration with a signal management configuration. You can then store and manage topics associated with product-event combinations in the integrated topic workflow configuration. The integrated topic workflow configuration can differ from the one used on the Topic Management page.

Note:

When describing topic-related activities, help topics reference the topic workflow configuration supplied with Oracle Empirica Topics.