The purpose and scope
of the SAS Clinical Standards Toolkit can best be described by considering
the product name.
Clinical
The SAS Clinical Standards
Toolkit focuses primarily on supporting clinical research activities.
These activities involve the discovery and development of new pharmaceutical
and biotechnology products and medical devices. These activities occur
from project initiation through product submission and throughout
the full product lifecycle. They do not include non-research patient
records or health-care, pharmacy, hospital, and insurance electronic
records.
Standards
The SAS Clinical Standards
Toolkit initially focuses on standards defined by the Clinical Data
Interchange Standards Consortium (CDISC). CDISC is a global, open,
multidisciplinary, nonprofit organization that has established standards
to support the acquisition, exchange, submission, and archival of
clinical research data and metadata. The CDISC mission is to develop
and support global, platform-independent data standards that enable
information-system interoperability, which, in turn, improves medical
research and related areas of health care. The SAS Clinical Standards
Toolkit is not limited to supporting CDISC standards. The SAS Clinical
Standards Toolkit framework is designed to support the specification
and use of any user-defined standard.
Toolkit
The term toolkit connotes
a collection of tools, products, and solutions. The SAS Clinical Standards
Toolkit provides a set of standards and functionality that will evolve
and grow with future product updates and releases. Customer requirements
and expectations of the SAS Clinical Standards Toolkit will play a
key role in deciding what functionality to provide in future releases.