The new eTMF Standards Technical Committee is forming under OASIS, a leading global standards development organization. Individuals with demonstrated expertise in domain areas related to clinical trial content classification, electronic content management, regulatory compliance and related areas are being recruited for participation on the Technical Committee (TC). The eTMF TC will meet bi-monthly and will work to release a draft eTMF specification and a machine readable content model within 6 months of its first meeting, tentatively scheduled for 16 December 2013, 9am-10am PST. The full CareLex / OASIS eTMF Standard press release is available for download here: http://www.prweb.com/releases/2013/9/prweb11088154.htm
The Need for a Standard
There is an urgent need for a globally available, open eTMF standard that will accelerate clinical trial information exchange and interoperability. An eTMF standard is essential for reducing or eliminating the use of manual paper-based processes in clinical trials. Automated electronic business processes can accelerate the safe delivery of new therapies to patients and can reduce drug development costs. An introduction to why we need an eTMF standard is outlined in the video below:
OASIS -Leading Global Standards Initiatives
OASIS is a leading standards development organization which has led collaborative development of multiple standards that are used globally and are recognized by governments and regulatory agencies worldwide. All of the major document management software vendors are part of OASIS. OASIS standards often are adopted by other standards bodies such as ISO, ITU or ANSI.
How to Participate in the Effort
Additional details and terms of membership are available to prospective members. Interested parties can express an interest in joining the eTMF Standards Technical Committee by contacting the OASIS standards development organization membership group via email at firstname.lastname@example.org or by submitting a contact request at the CareLex website at http://carelex.org/contact/ or via email to admin(at)CareLex(dot)org. Join the new LinkedIn eTMF Standards discussion group at http://www.linkedin.com/groups/eTMF-Standards-5161997/about
eTMF Standards Charter and OASIS eTMF Standards TC Membership FAQ Available
Background documents on the eTMF Standards Technical Committee (TC) are available for viewing and download below.
As a roadmap for the effort, the draft charter describes the statement of work, deliverables and expectations of prospective eTMF Standards TC members.
OASIS eTMF Standards TC – Charter Download
November 26 2013: The OASIS eTMF Standards Tech Committee charter has been published and finalized for public review. The public call for participation phase has started and all interested members should join the initiative now. The new group’s first meeting will be held on December 16 2013. Download a copy of the submitted eTMF Standards TC Charter below:
OASIS eTMF Standards TC – FAQ Download
Download the eTMF Standards TC FAQ here: