lab

 

So, on December 22nd I hosted a webinar to discuss the status update I had published on YouTube of ChAMP and gather feedback on what the attendees thought and what might be missing from the platform. The hour long discussion featured myself, Tony, and thirteen other attendees from various organizations.

In general, I got the feeling that the attendees thought there was a need for ChAMP, but that they needed to see it in action to fully understand the scope and usage.

Specific feedback was as follows

  • Controlled vocabularies
  • Use cases
    • Regulatory environment (FDA/SDD (Stability Data Standard), EPA/SEDD (Staged Electronic Data Deliverable) )
    • Standard for Exchange of Nonclinical Data (SEND)
    • IDMP (European)
      • ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
      • ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
      • ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances
      • ISO 11239, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
      • ISO 11240, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement.
    • Forensics...
  • Metadata
    • Chain of custody
    • Who did something? (i.e. Regulatory environment needs personnel)
    • Role(s)
    • Location(s)
    • Purpose? Why was this analysis done?

Looks like I have some additional work to do...