About Clinical Component Management

SAS Clinical Data Integration clinical components are the top-level containers for all of the content and metadata created during the course of an entire study. SAS Clinical Data Integration enables you to manage the following two types of clinical components:
  • a study, such as study-level metadata and content
  • a submission, such as aggregated metadata and content, or a collection of studies
In SAS Clinical Data Integration, a trial manager can centrally define and manage study definitions, set up default content, and monitor the progress of the domain mapping process.
Before you create a clinical component, you can define the defaults for the clinical component. You can use default folders to maintain consistent metadata organization in a clinical component when it is created. You can use default libraries to maintain consistent use of SAS librefs. This consistency is necessary when you have standard programs and macros that are dependent on consistent SAS librefs.
For each clinical component, you can define one or more default data standards. When defining a data standard, remember that you are affecting the available data standard selections in all SAS Clinical Data Integration wizards within that clinical component. Only the data standards that you define as the defaults are displayed. These default settings ensure that you are always using the correct version of a data standard for a study or submission. After you use the New Clinical Component wizard to create a clinical component, default content is created automatically in the new clinical component.
Because all activities and relationships are stored in metadata, SAS Clinical Data Integration can produce a summary of the statuses of all activities for a selected study or submission. If you have multiple programmers working on the same submission or study, you can easily see what domains have been created, what domains are used in a mapping process, and whether a validation transformation is using a certain domain. If you are using change management, you can view who is working on the submission or study. For more information about change management, see SAS Data Integration Studio: User’s Guide.
Typical user tasks include the following:
  • working with default folders and libraries
  • creating and defining a clinical component
  • monitoring the statuses of domains
  • refreshing a standard domain