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