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Electronic trial master file information


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. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.

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Electronic trial master file

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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...

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Trial master file

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information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference...

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EPharmaSolutions

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Award[citation needed] making it the most widely used Clinical Trial Portal and Electronic Trial Master File solution[buzzword] in the pharmaceutical industry with...

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Social Security Death Index

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Administration's Death Master File until 2014. Since 2014, public access to the updated Death Master File has been via the Limited Access Death Master File certification...

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Electronic publishing

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Electronic publishing (also referred to as e-publishing, digital publishing, or online publishing) includes the digital publication of e-books, digital...

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Electronic data processing

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customer master files, booking and ticketing transactions to an airline's reservation system, billing for utility services. The modifier "electronic" or "automatic"...

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Electronic common technical document

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Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs). Health Canada was a sponsor and an early adopter of the eCTD...

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Mastercard

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June 10, 2022. "MasterCard's QkR mobile payment system enters trial in Australia". January 27, 2012. Retrieved January 26, 2014. "MasterCard starts piloting...

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ENIAC

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ENIAC (/ˈɛniæk/; Electronic Numerical Integrator and Computer) was the first programmable, electronic, general-purpose digital computer, completed in 1945...

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Juan Merchan

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“As a retiree, I was able to attend each day of the Trump trial. What I saw was a master class in what a judge should be — how one can serve fairly and...

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Special master

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administrative matters falling short of a full trial. In the federal judiciary of the United States, a special master is an adjunct to a federal court. Rule 53...

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Legal aspects of file sharing

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programs, multimedia (audios, photos and/or videos), program files, documents or electronic books/magazines. It involves various legal aspects as it is...

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The Master and Margarita

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". Folklore: Electronic Journal of Folklore. 84: 7–24. doi:10.7592/FEJF2021.84.sazonov_kupp-sazonov. Bulgakov, Mikhail (2016). The Master and Margarita...

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Murder of Travis Alexander

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jury could be seated in light of the coverage of the trial. During the trial, defense attorneys filed for mistrial in January, April and May 2013. Arias's...

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FL Studio

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extension. The trial allows users to save projects, but does not allow reopening them. Tracks may be exported to any of the available file formats. FL Studio...

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Electronic identification

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its electronic identity cards, called e-KTP. It was trialed in six areas in 2009 and launched nationwide in 2011. Italy introduced its electronic identity...

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Peggle 2

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2 was praised for its new masters and the implementation of them; its vibrant visuals; soundtrack; and the addition of trial levels and challenges. However...

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Accounts payable

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companies also separate the functions of adding new vendors to the master vendor file and entering vouchers. This makes it impossible for an employee to...

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Recording Industry Association of America

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FreeCulture.org. "How to Not Get Sued For File Sharing" Archived August 29, 2008, at the Wayback Machine Electronic Frontier Foundation. Blankenhorn, Dana...

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Clinical trial

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clinical trial databases. Electronic health records (EHR). Some systems integrate with EHRs to automatically flag patients that may be eligible for trials based...

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Murders of Rachel and Lillian Entwistle

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Nottingham and attended the University of York, receiving a master's degree in electronic engineering. He grew up in Worksop with his parents, Clifford...

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New York business fraud lawsuit against the Trump Organization

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but the form filed by his lawyers indicates that they consented to a "trial without jury". Judge Engoron later said that a jury trial would not have...

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Health informatics

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clinical trials. CDE initiatives, for example, try to allow clinical trial designers to adopt standardized research instruments (electronic case report...

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Digital currency

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database on the internet, a centralized electronic computer database owned by a company or bank, within digital files or even on a stored-value card. Digital...

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