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In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
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.
Tracing in software engineering refers to the process of capturing and recording information about the execution of a software program. This information is typically used by programmers for debugging purposes, and additionally, depending on the type and detail of information contained in a trace log, by experienced system administrators or technical-support personnel and by software monitoring ...
event trace log file Microsoft [88] [89] EVT: Windows Event log file Microsoft Windows NT 4.0 - XP; Microsoft Event Viewer: EVTX: Windows Event log file XML structured Microsoft Windows Vista, 7, 8; Microsoft Event Viewer: EX: Elixir source code file Elixir programming language running on BEAM (Erlang virtual machine) [90] EXE: Directly ...
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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In software development, a traceability matrix (TM) [1]: 244 is a document, usually in the form of a table, used to assist in determining the completeness of a relationship by correlating any two baselined documents using a many-to-many relationship comparison.