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.
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