eTMF Standard Outreach

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Communicating with organizations focused on clinical trials interoperability, eTMF standards development
and ontology development.

Statement of Purpose

The eTMF Standards Outreach Subcommittee shall reach out to Biopharma sponsors, clinical research organizations, health science technology firms, associations, research universities, government regulatory agencies, and any other allied organizations focused on clinical trials interoperability, eTMF standards development and/or ontology development. The subcommittee will invite participation on the eTMF Standards TC and learn more about the initiatives of prospective members.

Subcommittee work shall be publicly available on the OASIS eTMF Standards TC's website.

Deliverables:
  • List of organizations involved in eTMF technology development
  • Email template/message for outreach email
  • Send Email to profiled organizations to learn about what they are doing, invite to participate.
  • Summary report - including but not limited to the following:
    - List of Organizations involved in eTMF technology development - Org name, Type of org (e.g., non-profit, for profit, academic, gov), type of work, list any interoperability technical requirements by priority of importance, current technology formats in use to represent eTMF data (Excel spreadsheet, XML, etc.)

Providing Feedback: OASIS welcomes feedback on its technical activities from potential users, developers, and others to better assure the interoperability and quality of OASIS work.