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Agenda

Guiding Goal: Group deliverables and health care sector data harmonization.

Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, attributes, controlled terms, and other specified metadata were used.

We then hammer it home by flagging all attributes that could potentially unblind the identity of a governing entity and create entry, label and information overlays in English and Chinese for language resolution at the application layer.

Meeting Notes

Recording


Participants (Name / Location / Time zone / Affiliation):


Leadership positions:

(Note: We plan to instigate an official submissions, nominations and voting process. In the meantime, please put your name down if you are interested in volunteering for either a Chair or Vice-chair position.)