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All records, in any form (including, but not limited to, written electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a trial, and the actions taken. Also referred to as “Source Documents".
Publication Source: Committees on Human Research
(ANSI) The aids provided for the understanding of the structure and intended uses of an information system or its components, such as flowcharts, textual material, and user manuals.
Publication Source: FDA Glossary of Computerized System and Software Development Technology
Any written or pictorial information describing, defining, specifying, and/or reporting of certifying activities, requirements, procedures or results.
Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition
Publication Date: 2007
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