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A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
CHMP/EWP/2459/02: Methodological issues in confirmatory clinical trials planned with an adaptive design [33] (EMA) focuses on the opportunities for interim trial design modifications, and the prerequisites, problems and pitfalls that must be considered as soon as any kind of flexibility is introduced into a confirmatory clinical trial intended ...
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After a six-week trial filled with drama and emotion, a jury of nine men and three women found Grossman guilty of two counts of second-degree murder, two counts of gross vehicular manslaughter and ...
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
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