SAS Clinical
Data Integration studies and submissions are the top-level containers
for all of the content and metadata created during the course of an
entire study. A study contains study-level metadata and content. A
submission contains 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
study or submission, you can define the defaults for the study or
submission. You can use default folders to maintain consistent metadata
organization in a study and submission 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 study and submission,
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 study or submission. 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 create a study or submission, default
content is created automatically.
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.