Electronic Trial Master File (Etmf) Specification Version 1.0

Electronic Trial Master File (eTMF) Specification Version 1.0

Format change notice

08 August 2016

Important notice:

As of the date above, this document (Electronic Trial Master File (eTMF) Specification Version 1.0) is no longer maintained in the Microsoft Word “.doc” format.

The latest version is available in the formats listed immediately below.

Latest version:

http://docs.oasis-open.org/etmf/etmf/v1.0/etmf-v1.0.docx (Authoritative)

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

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

Technical Committee:

OASIS Electronic Trial Master File (eTMF) Standard TC

Chair:

Zack Schmidt (), SureClinical

Editors:

Aliaa Badr (), CareLex

Jennifer Alpert Palchak (), CareLex

Rich Lustig (), Oracle

Catherine Schmidt (), SterlingBio

Zack Schmidt (), SureClinical

Airat Sadreev,(), SureClinical

Troy Jacobson,(), Forte Research Systems

Prabhat Vatsal (), Next Docs