The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Foundational Standard that describes how to represent data for the natural history and efficacy studies conducted in animals submitted to applications under the U.S. Food and Drug Administration (FDA) regulations commonly known as the Animal Rule.
The Animal Rule provides a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.
The foundational data standard is an important tool that will help maximize the investment in Animal Rule studies. The standard will ultimately streamline data reporting to the FDA to enhance learnings from these important animal studies, and will serve to accelerate therapies for humans."
Rick Liwski, C-Path Chief Technology Officer and Data Collaboration Center (DCC) Director
The standard, released in the form of an Implementation Guide and Model for data managers, statisticians, programmers and study managers, is freely available on the CDISC website. "We are quite excited about the release of this important standard that supports a regulatory submission mechanism vital to public health," said David R. Bobbitt, MSc, MBA, CDISC President and CEO. "Congratulations to all who have contributed their time and expertise to the development of this standard."
CDISC Foundational Standards are the basis of a complete suite of data standards, enhancing the quality, efficiency and cost effectiveness of clinical research processes from beginning to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.