Improved Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications

Critical Path Institute, Tucson AZ

Investigators

Abstract

Project Summary: Improved Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) Counter-Terrorism and Emergency Coordination Staff (CTECS) has stated the need for a data standard to facilitate the electronic submission of applications for products developed under the Animal Rule. Data standards that align with current Clinical Data Interchange Standards Consortium (CDISC) study data tabulation model (SDTM) and Standard for the Exchange of Nonclinical Data Implementation Guide (SENDIG) modeling approaches, and that fill the gaps necessary to accommodate the unique needs of Animal Rule data submissions are needed. In response to the FDA CDER statement of need this project has the following three specific aims 1) Gather inputs from FDA CDER CTECS, including more detailed examples of the unmet need, inadequacies in the existing data standards, data model and rules, and any prior work completed. 2) Create or modify existing SDTM domains and variables (as needed), where the current definitions or uses are inadequate for the specific needs of the animal efficacy and natural history studies for Animal Rule applications, while taking care to adhere to the core principles of the data model and overall best practices in data modeling. 3) Develop and publish an Animal Rule-specific SEND implementation guide complete with examples illustrating the rules, concepts and use cases for any new domains and variables required.