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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 ...
The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for clinical data management can be self-contained or part of the functionality of a CTMS.
Nation's Worst Cold Outbreak. Adding an exclamation point to a two-week siege widely considered the nation's worst, most prolific cold outbreak, a Blue Norther plowed through the Plains on Feb. 10 ...
After a related segment on “Fox & Friends” Thursday morning, Trump wrote, “I said, many times during Rallies, and elsewhere, that Radical Islamic Terrorism, and other forms of violent crime ...
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.