Federal Register Notice: CDER and CBER are announcing a pilot project to evaluate the Clinical Data Interchange Standard Consortium (CDISC) Submission Data Standards (SDS) Extensible Markup Language (XML) transport format for submitting regulatory study data. The current study data transport format supported by FDA is the SAS Transport version 5 file format, which is not an extensible modern technology. SDS XML is an extension of the CDISC Operational Data Model, which is a vendor neutral, platform-independent format for the exchange and archive of study data. FDA is inviting sponsors to participate in this pilot project to evaluate the SDS XML transport format. Electric or written requests for participation should be submitted by 1/27/14. To view this notice, click here.