The number of study types in scope of SEND has gradually increased for submissions to the U.S. FDA, and “studies related to embryo-fetal development” are the next (DART studies starting on and after March 15, 2023 for NDAs and those starting on and after March 15, 2024 for INDs), and the guideline of SENDIG DART v1.1 had already been finalized by CDISC. In the SENDIG DART v1.1, new 7 domains were added and modifications specific to DART studies were made onto the existing domains. It seems difficult to be compatible with these alterations only with the knowledge of SEIDIG v3.1, and therefore understanding of SENDIG DART v1.1 is essential. Under this circumstance, we have created SEND data in accordance with the SEND DART v1.1 using in-house study data on embryo-fetal development in rabbits to investigate issues that may occur during creation of SEND data for DART studies. As a result, we encountered various issues such as information that cannot be interpreted from the guideline, examinations that are not included in the controlled terminologies, SEND conversion of observation methods specific to the test facility and methodology of data population for animals that aborted. Despite such difficulties, we managed to complete the creation of SEND dataset through discussions with the involved parties including our business associate. In this presentation, we summarized the specific issues occurred during the SEND dataset creation and practical examples of the methodologies we had established through the discussions.
