Dataset-JSON as Alternative Transport Format for Regulatory Submissions

The scope for the project covers twin objectives:

1. Demonstrate that Dataset-JSON can transport information with no disruption to business​
   
2. Demonstrate the viability of Dataset-JSON as the primary transport option

1. Pilot Submissions Report

• Consolidate feedback from the pilot submissions and develop report

2. Business Case

• Establish the overall business case for using Dataset-JSON for submissions to justify the investment needed to implement the changes​

3. Technical Implementation

• Develop and document software tools to be used in the pilot to include updates to existing products​

4. Strategy for Future Development

• Define a roadmap for future development and changes to the CDISC Foundational Standards

The XPT file format is outdated and imposes limitations on submission data due to the lack of modern features – for example, XPT files are limited to US ASCII Character encoding, have restricted variable names/sizes, inefficient use of storage space, use a non-extensible tabular structure and lack any integrated metadata. The impact of overcoming these limitations will be seen initially by regulators; however, by far the bigger impact will be seen in the medium to longer term, where, by lifting the restrictions of XPT, and moving to Dataset-JSON, new standards will be able to take advantage of these enhanced capabilities, and drive efficiencies, consistency and re-usability across the clinical research data life cycle.