Proposal for Efficient Collaboration Process for Creating a SEND Data Package between Sponsors-CROs

<p>The FDA has mandated the submission of standardized electronic data (SEND data package) in compliance with CDISC SEND for nonclinical study data such as single and repeated dose toxicity studies for new drug development applications in the US.</p><p>The CJUG (CDISC Japan User Group) SEND team has reported that variations are found in the specifications and quality of SEND data among SEND creators.</p><p>This variation badly affects not only secondary use of the SEND, but also causes inefficiency in the process of creating and ensuring the quality of the SEND data. For example, pharmaceutical industries often meet the difficulties in checking the qualities of the SEND datasets created by the SEND creating facilities according to their own internal specifications, which are often different between the creating facilities; on the other hands, SEND creating facilities also meet the difficulties in creating the SEND data according to the different types of internal specification between sponsor industries.</p><p>The CJUG SEND team has focused on building efficient process for ensuring the qualities of SEND data via pre-defined specifications before the creation and the unified quality check after that. Based on these concepts, we created the template of SEND data specification using define.xml format and the SAS-based check tool (CJUG SEND Check Tool).</p><p>This presentation will propose an efficient process for creating SEND data packages via pre-defined SEND data specification and CJUG SEND Check Tool, which could enable Sponsors-CROs to collaborate efficiently.</p>