A Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) is developed in reference to a specific SDTM model. However, the SDTM is cumulative – each new release builds on the previous model. Therefore, the models are backward compatible. The SENDIG is designed to support data typically found in single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies, as well as respiratory and cardiovascular testing conducted during safety pharmacology studies.
Additional SENDIGs have been developed to support other study types. For example, SENDIG-DART v1.1 supports submission of data from nonclinical Developmental and Reproductive Toxicology (DART) studies and SENDIG-AR v1.0 supports the submission of data from studies conducted under the Animal Rule. In addition to models and implementation guides, conformance rules have been developed, which help to ensure that generated data structures conform to the standards. These rules aim to identify all conformance rules and case logic from the SENDIG, classifying and codifying them in a form that supports quality processes and tool development.
Public Review - SEND
SEND: The Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) is based on the SDTM and guides users on the organization, structure, and format of standard nonclinical study tabulation datasets for exchange between organizations or to be submitted to a regulatory authority. The following videos introduce you to the SENDIG and the SDTM, which used together serve as a map that orients you on how your data fits into the standard.