SEND

SEND is the Standard for the Exchange of Nonclinical Data, published by the Clinical Data Interchange Standards Consortium (CDISC) and is the required submission format for study data submitted in an electronic Common Technical Document (eCTD) to the FDA when making Investigational New Drug (IND) and New Drug Application (NDA) submissions. This chapter provides the reader with a working understanding of the submission standard. As well as describing the purpose of the standard and its importance in the review of a regulatory submission, the chapter provides background and introduction, before examining the details regarding how nonclinical study data are represented in SEND. The main text provides information on the required XPT file format for the SEND datasets and also describes the role of the define.xml accompanying file. It describes the types of studies currently in scope of the requirement and gives specific details regarding the representation of Cardiovascular and Respiratory Safety Pharmacology studies as well as Embryo Fetal Development Developmental and Reproductive Toxicology studies.