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10 July 2012
eCliniqua: 2012 Survey Demonstrates Growth in eTMF and Impact of Standards
In June 2010, an industry
coalition, under the auspices of the Drug Information Association,
published version 1.0 of the Trial Master File Reference Model (TMF RM).The
Trial Master File (TMF) contains those essential documents that
individually and collectively permit the evaluation of the conduct of a
clinical trial and the quality of the data produced. Until this version
of the TMF RM was released, there was no comprehensive common industry
model for the TMF.
The TMF RM presents a
consensus position on the content that supports the evaluation of the
conduct of a trial and the quality of the data produced, in accordance
with industry opinion and best practices. By design, the TMF RM is a guidance and not a regulatory standard.The
team that developed the TMF RM is composed of approximately 275
representatives from more than 165 biopharmaceutical companies, contract
research organizations (CROs), consultancies, vendors, industry groups,
healthcare, academia, non-for-profit / NGO and regulatory agencies.
To find more information please use the below