Users and Vendors of Trial Master File Systems Called To Action

zxsadminClinical Trials, eTMF

On June 24, OASIS released the Electronic Trial Master File (eTMF) Specification Version 1.0 CSD01 and the OASIS eTMF Standard Technical Committee seeks Public Review over the next 45 days. The review period ends on August 8th. You can find the announcement and documents at https://www.oasis-open.org/news/announcements/45-day-public-review-for-electronic-trial-master-file-etmf-specification-version-

Developed as a standard based upon standards, the goal of the Draft OASIS eTMF Committee Specification is to:

  • Enable data portability for seamless exchange of digital records between various collaborators on a clinical trial
  • Facilitate data quality and compliance
  • Support efficient search, report, and audit of clinical trial documents and their associated records

The Draft Electronic Trial Master File (eTMF) Specification Version 1.0 incorporates global technical standards and controlled terms developed by BRIDG (CDISC), CareLex, Dublin Core, HL7, National Cancer Institute, and TMF Reference Model.

Vendors gain early insight into the direction of the standard and can provide input to shape the standard.  Users of this developing standard will benefit from increased data quality and portability thereby minimizing risk.

OASIS requires Public Review comments be submitted through the TC’s comment list etmf-comment@lists.oasis-open.org. The benefit of this process is that it is open to all and publicly viewable to all as well.

The Electronic Trial Master File (eTMF) Specification Version 1.0 Committee Specification Draft 01 consists of three elements for review:

1)  eTMF Specification Draft document

2) eTMF RDF/XML machine code file, and

3) Metadata Vocabulary Spreadsheet

For your convenience, OASIS provides a complete package of the prose document and related files in a ZIP distribution file. You can download the ZIP file here:

http://docs.oasis-open.org/etmf/etmf/v1.0/csprd01/etmf-v1.0-csprd01.zip

OASIS eTMF Standard TC members who have participated in development of this specification include:

CareLex,  EMC,  Forte Research Systems,  Health Level 7,  Mayo Clinic, NextDocs, Oracle, Paragon Solutions, Phlexglobal Ltd., Safe-BioPharma Association, Sterling Bio, SureClinical, and the University of Michigan.

OASIS is a non-profit, international consortium that drives the development, convergence and adoption of open standards.  OASIS is distinguished by its transparent governance and operating procedures.  The OASIS consortium has more than 5,000 participants representing over 600 organizations and individual members in 100 countries.  Global document system vendor organizations such as Alfresco, EMC, IBM, Microsoft, Oracle and many others are contributors to OASIS and members of OASIS, demonstrating the long-term commitment vendors have made toward interoperable systems and data portability.