To manage the process of identifying and investigating drug safety issues, including organizing the collection and interpretation of information from different sources over time, you can create topics. 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 states such as Initial, Reviewed, or Completed. You can monitor topics from creation to completion on the Topics page and by using reports. You can also download all, or a selected subset, of the information stored with a topic to a PDF file.
When you create and edit topics, information is collected using a structured, predefined layout of fields. While a sample, standard layout is provided with Empirica Signal, it is likely that your organization has customized the layout supplied with the application to meet the specific requirements of your organization, including:
· 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: 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.
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 might structure the participation of several members of a work team on every topic, while a separate notebook topic workflow configuration might allow 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 might allow you to work cooperatively with others on projects using topics and also allow you to 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 Signal Management, a topic workflow configuration can be integrated with a signal management configuration. Topics associated with product-event combinations can be stored and managed 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 the application.
You access topics through the Topics page. You must have the View Topics permission and an administrator must set up the topics feature for your use, including assigning a topic workflow configuration to your login group, and, if needed, assigning work team permissions. For information on setting up the topics feature see Set up the Topic feature.