The Trial Master File Reference Model (TMF RM), a supported initiative through the Document and Records Management SIAC of the Drug Information Association (DIA) is a standard reference for the contents of a Trial Master File. First published in 2010, it is a single, unified interpretation of the regulations and best practices and was collaboratively developed through a volunteer effort that includes more than 150 companies. The TMF RM is free and available here. Version 2 (due mid 2012) will include additional details for Investigator Site Files, Investigator Initiated Studies, Process-based Metadata and Device Studies.
A quick online survey has been designed by members of the TMF Reference Model team to provide valuable insight into Trial Master File practices, both paper and electronic, to identify common problem areas, assess changes in practice and reveal opportunities for improvement. All respondents who complete the survey and provide contact information will be provided with the survey results. This will be a valuable industry tool so please do click on this link and complete the survey by June 1, 2012.Disclaimer: In accordance with the DIA Volunteer Code of Conduct, no volunteer shall use any information provided by the Association or acquired as a consequence of volunteer’s services to the Association in any manner other than in furtherance of his or her volunteer duties with DIA. Volunteers are expected to act at all times in the best interests of the Association and not for personal or third-party gain or financial enrichment. DIA reserves the right to reproduce, license, sell, display, and distribute copies of materials posted to the DIA website, in any medium or technology (including online) consistent with DIA’s non-profit and tax exempt purposes.