PHUSE/CDISC Dataset-JSON Pilot Update
The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project hosted a Webinar which took place on 1 February. The Webinar provided a mid-project status report and overview of the process made across the four sub-teams. The joint PHUSE/CIDSC project is building upon the considerable amount of work done over the years to replace XPT as the default file format for clinical and device data submissions to regulatory authorities. Please take a look at the recording below. |
Dataset-JSON Webinar | |
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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 |