OASIS Recognizes eTMF Standard Technical Committee

Hearty congratulations go out to all members of the OASIS eTMF Standard Technical Committee (eTMF Standard TC).  The eTMF Standard TC has been recognized by OASIS Open for their outstanding work as a TC and for record-setting engagement of public comment on their work.  As co-chair of the TC, I can attest to the many hours these talented TC members have dedicated toward development of an interoperability standard for the electronic trial master file.

In recognition for the accomplishments of participants in OASIS’ many technical committees, OASIS introduced the OASIS the Open Standards Cup with recognition awarded to TCs in two categories, Outstanding Accomplished TC and Outstanding New TC.

The eTMF Standard Technical Committee was recognized by OASIS as a 2014 Outstanding New TC Finalist in the Open Standards Cup.  In its inaugural year, the Open Standards Cup offers prestigious recognition for the outstanding efforts of OASIS eTMF Standard TC members and their contributions.

The eTMF Standard TC has also been notified by OASIS for having set an OASIS technical committee record for the volume of public comment during a TC’s Committee Specification Draft public comment period.

OASIS eTMF Standard Technical Committee members include organizations from BioPharma technology companies, research universities, CROs, BioPharma consulting firms, standards organizations, and more.  The aim of the TC is to define machine readable formats for clinical trial master file content interoperability and data exchange.  The TC’s charter, list of members and work are publicly viewable on OASIS’ eTMF Standard TC page.

OASIS is a non-profit consortium that drives the development, convergence and adoption of open standards for the global information society. OASIS is distinguished by its transparent governance and operating procedures.

OASIS promotes industry consensus and produces worldwide standards for security, Internet of Things, cloud computing, energy, content technologies, emergency management, and other areas. OASIS open standards offer the potential to lower cost, stimulate innovation, grow global markets, and protect the right of free choice of technology.

OASIS members broadly represent the marketplace of public and private sector technology leaders, users and influencers. The consortium has more than 5,000 participants representing over 600 organizations and individual members in more than 65 countries.