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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 ...
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 ...
Agency executive. Rebecca J. Williams, Director. Website. ClinicalTrials.gov. ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and holds registrations from over 444,000 trials from 221 countries. [1]
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 ...
A clinical research associate ( CRA ), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.