Encouragement for involvement of toxicologists in improving the quality of SEND data and how to use the CJUG SEND check list

Abstract

The FDA has mandated submission of standardized electronic data in compliance with CDISC SEND. However, SEND-specific personnel mainly create SEND data and involvement of toxicologists is often limited because the creation requires specialized knowledge and skill such as SENDIG and use of xpt files. CJUG SEND team has created a new check list summarizing points to be considered when creating SEND data. In this presentation, importance of involvement of toxicologists in creating SEND data and in solving issues in the creation process with efficient use of the check list will be introduced.