Dataset-JSON as Alternative Transport Format for Regulatory Submissions

Project Scope 

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The XPT file format is outdated and imposes limitations on submission data due to the lack of modern features – for example, XPT files are limited to US ASCII Character encoding, have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.

Sam Hume, CDISC

shume@cdisc.org 

Stuart Malcolm, Veramed

stuart.malcolm@veramed.co.uk

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global

• Business Case Published.

• Project now closed.

White Paper

Business Case

Pilot Participation Testing and Reporting Instructions

Summary of The Pilot Findings To Date and Recommended Solutions

SBIA Webinar: Dataset-JSON Pilot Report and Next Steps

Introduction, presented by Stuart Malcom, Veramed

Pilot Submissions Status Update, presented by Sam Hume, CDISC

Technical Implementation Topics, presented by Jesse Anderson, FDA

Business Case, presented by Marguerite Kolb, Johnson & Johnson

Strategy for Future Development, presented by Nicole Thorne, BMS