The presentation is intended for those who need to prepare CDISC electronic submission to agency. The paper will discuss why we need to understand CDISC electronic submission. It will explain the significant regulatory changes lately such as FDASIA and PDUFA V. It will also discuss how to prepare CDISC electronic submission such as eCTD and FDA CDER Data Standard Strategy and finally what to prepare for CDISC electronic submission such as CSR, Protocol, SAP, SDTM annotated eCRF, SDTM datasets, ADaM datasets, ADaM datasets SAS Programs and Define.xml and their formats.