抄録
With the requirement for electronic data standards scheduled to begin December 18, 2016, the pharma community is on the edge of a major change in the way data need to be collected and reported, as well as the way regulatory authorities will be able to analyze data. To go along with these changes are benefits from data warehouses and sophisticated data analysis tools that can offer immediate access to data in ways not currently feasible. As we approach the start of FDA's mandate for SEND, the quality of SEND implementation for submissions becomes critical. In this presentation, best practices for SEND implementation based on extensive FDA SEND submission experience will be shared. SEND Readiness in terms of the ability to use electronic raw data to automatically create SEND datasets will be reviewed, along with suggestions for protocol designs that best conform to the SEND model. RecommendatioNoncompliance to the standard can result in Refusal to File by FDA ns will be presented for SEND dataset review, both for accuracy and fitness of data for analysis. Updates from CDISC and PhUSE, including SENDIG 3.1 timelines and challenges, Define standard, and Study Data Reviewer's Guide (SDRG) content and format will be highlighted.
