Efficacy is defined as “the ability to produce a desired or intended result.” Clinical trials..
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published criteria that define when cancer..
Clinical research is key in the exploration of whether a new medical strategy, or treatment,..
Clinical Data Management (CDM) encompasses the entry, verification, validation, and quality control of data gathered..
Data privacy or information privacy is the relationship between collecting and disseminating data and the..
The U.S. Code of Federal Regulation (CFR), Title 21 Food and Drugs, Chapter 1 Food and Drug..
Clinical Trial Phase: Clinical trials are done in phases that have different purposes and help researchers..
Use of standards has become increasingly widespread within clinical data management. There are few regulatory..
The ICH Guidance for Industry: E6 Good Clinical Practice defines the term “case report form” as, “A printed, optical,..
Each clinical trial has a master plan called a protocol. The protocol describes the scientific..
Up until the 20th century, there were few federal laws regulating the contents and sale..
September 03, 2013
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