![]() ![]() The most recent release of the DIA TMF Reference Model, version three, was released by the TMF Working Group in June 2015. A 2015 survey conducted by DIA indicates that 85 percent of eligible respondents either currently use the DIA TMF Reference Model, are in the process of implementing the trial master file reference model, or are considering using the model. Investigators who manage investigator site files or conduct investigator initiated studies also find the DIA TMF Reference Model useful. The intended audience of the DIA TMF Reference Model includes biopharmaceutical and medical device companies, contract research organizations (CROs), vendors, and other parties involved in the management of study-specific TMFs. While not actually a regulatory standard in and of itself, the DIA TMF Reference Model is reviewed by regulatory authorities for the benefit of gaining valuable compliance input and serves as an extension of the electronic document management (EDM) Reference Model. The DIA TMF Reference Model allows organizations to effectively compile the minimum list of essential documents that will serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements. As specifically stated in ICH GCP Section 8, such documents are “those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.” Since the ICH GCP does not provide a comprehensive list of contents for the TMF, the DIA TMF Reference Model provides a generally accepted structure for TMF-related data, documents, artifacts, and activities. The DIA TMF Reference Model helps companies meet the “essential documents” compliance requirements that have been set forth by the International Conference on Harmonization (ICH). ![]()
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