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.Įach new SEND release must be assessed and realigned to the SDTM to facilitate data sharing across and within nonclinical and clinical research (e.g., ability to aggregate and analyze data across studies, tissues/systems, and classes of compounds). In addition to models and implementation guides, conformance rules have been developed, which help to ensure that generated data structures conform to the standards. 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. 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.Īdditional SENDIGs have been developed to support other study types.
Therefore, the models are backward compatible. However, the SDTM is cumulative – each new release builds on the previous model. A Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) is developed in reference to a specific SDTM model.
