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Home » Determine the Who, What, When and Where of Requirements
Determine the Who, What, When and Where of Requirements
November 4, 2010
The preamble of the FDA’s proposed rule, Reporting Information Regarding Falsification of Data, addresses the question of whose actions must be reported. It states that a sponsor must report the falsification of data by “any person” involved in a study. This includes not just investigators, but also their colleagues (co-investigators) and subordinates, such as any study coordinator or laboratory technician. It further states, “all persons must be identified so that future falsification of data can be prevented.”