Abstract #3233

Conversion of legacy data of nonclinical trials using MRI into CDISC SEND: Toward Standardization of an Animal MR Imaging Data

Do-Wan Lee¹, Young Chul Cho², Mi-hyun Kim^3,4, Yeon Ji Chae⁵, Su Jung Ham³, Yousun Ko¹, Seongwon Na², Youngbin Shin², Nari Kim⁶, Dong‐Cheol Woo^5,7, and Kyung Won Kim²

¹Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of, ²Biomedical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea, Republic of, ³Trialinformatics Inc., Seoul, Korea, Republic of, ⁴Department of Radiation Science & Technology, Jeonbuk National University, Jeonju, Korea, Republic of, ⁵Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of, ⁶Department of Medical Science, Asan Medical Institute of Convergence Science and Technology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of, ⁷Convergence Medicine Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea, Republic of

Synopsis

Keywords: Visualization, VisualizationIn nonclinical animal research for new drug development, the US FDA mandates to manage data in accordance with clinical data interchange standards consortium (CDISC) standard for exchange of nonclinical data (SEND). Older nonclinical trial data, i.e., legacy nonclinical trial data, contain highly useful information but those data were created in various data formats by different researchers. The present study specifically describes how to implement the CDISC SEND data standards for the legacy nonclinical trial data with MRI. Standardization of animal MRI data with CDISC SEND enables us to utilize legacy data for next-generation drug development and new knowledge creation.

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