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These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements." [1] Historically, TMFs have been paper-based content sets stored in physical file cabinets, central file rooms, or shelved in binders. The size and complexity ...
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 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has issued guidelines on establishing an equivalence between modes of administration. [13] Their approach is hierarchical and depends on the degree of change made during the process of migration from paper to electronic format. Three levels are suggested.
In econometrics and related empirical fields, the local average treatment effect (LATE), also known as the complier average causal effect (CACE), is the effect of a treatment for subjects who comply with the experimental treatment assigned to their sample group.
Technical reports are often prepared for sponsors of research projects. Another case where a technical report may be produced is when more information is produced for an academic paper than is acceptable or feasible to publish in a peer-reviewed publication; examples of this include in-depth experimental details, additional results, or the ...
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
In scientific writing, IMRAD or IMRaD (/ ˈ ɪ m r æ d /) (Introduction, Methods, Results, and Discussion) [1] is a common organizational structure for the format of a document. IMRaD is the most prominent norm for the structure of a scientific journal article of the original research type.
The identification phase is when potentially responsive documents are identified for further analysis and review. In the United States, in Zubulake v. UBS Warburg , Hon. Shira Scheindlin ruled that failure to issue a written legal hold notice whenever litigation is reasonably anticipated will be deemed grossly negligent.