Dataset-JSON as Alternative Transport Format for Regulatory Submissions
Project Scope | |
The scope for the project covers twin objectives:
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Sub Teams |
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1. Pilot Submissions Report
2. Business Case
3. Technical Implementation
4. Strategy for Future Development
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Project Impact |
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The XPT file format is outdated and imposes limitations on submission data due to the lack of modern features – for example, XPT files are limited to US ASCII Character encoding, have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. |
Project Leads | |
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Sam Hume, CDISC | |
Stuart Malcolm, Veramed | |
Nicola Newton, PHUSE Project Assistant |
CURRENT STATUS Q4 2024 |
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Objectives & Deliverables | Timelines |
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PHUSE Team formation Engaged with collaboration partners (CDSIC, FDA etc.) | Q2 2023 |
Initial technical/ regulatory deliverables CSS workshop – Workstream roundtable | Q3 2023 |
Industry deliverables (PHUSE EU Connect) | Q4 2023 |
Standards deliverables | Q1 2024 |
All project deliverables published CSS workshops – Project findings and recommendations | Q2 2024 |
Dataset-JSON Webinar Please find the recording and presentations from the Webinar that took place on 1 February. | |
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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 |