METRICS SURVEY IS NOW CLOSED
Survey Results are being compiled and registered recipients will receive a final report in January.
Welcome to the TMFReferenceModel.com
The survey was developed by a sub-team of the Trial Master File Reference Model (TMF RM) team. The initiative to create a TMF RM is supported by the Document and Records Management SIAC of the Drug Information Association (DIA), a recognized and highly respected professional association.
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Additional materials for reference:
- Download the TMF Reference Model.
- Information about the TMF RM project can be found here.
- For DIA TMF Reference Model Slides click here.
Purpose
The purpose of this survey was to better understand our industry's current processes for collecting, measuring, and identifying TMF quality, costs and effectiveness. Our goal is to attempt to quantify the cost, quality and effectiveness of the TMF. The responses to the survey will yield valuable data and insight on current Trial Master File practices, identify common problem areas and reveal opportunities for process improvement. All respondents providing contact information will be provided with the survey results. In no instance will survey respondents be identified. All survey data will be provided as raw data.
Recent Updates
NEW TRIAL MASTER REFERENCE MODEL
The Trial Master File Reference Model is a collaborative effort of 120 representatives from 75 biopharmaceutical companies, contract research organizations, consultancies, technical vendors, and regulatory agencies. This model consists of standardized taxonomy and metadata and outlines the clear definition and organization of TMF content using standard nomenclature. The Model provides an opportunity for standardization across the industry, and can be used by any company in an electronic or paper format. More…