What Is the SAS Clinical Standards Toolkit?

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.

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. In time, the SAS Clinical Standards Toolkit will support other evolving industry-standard data models. The SAS Clinical Standards Toolkit framework is designed to support the specification and use of any user-defined standard.

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 the deciding what functionality to provide in future releases.