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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. The EU Commission's Directive 2005/28/EC 63 Chapter 4 states 'the trial master file shall consist of essential documents ...
Open-label trial. An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants. [1] In particular, both the researchers and participants know which treatment is being administered. [1] This contrasts with a double-blinded trial, where information is withheld both from the ...
The National Library of Medicine in the National Institutes of Health made ClinicalTrials.gov available to the public via the internet on February 29, 2000. [6] In this initial release, ClinicalTrials.gov primarily included information about NIH-sponsored trials, omitting the majority of clinical trials being performed by private industry.
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 ...
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A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...
