ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Protocol

(ISO) A set of semantic and syntactic rules that determines the behavior of functional units in achieving communication.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

Protocol

A prospective plan, that when executed as intended, produces documented evidence that a Process or System has been properly qualified.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

Protocol

The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.

Publication Source: Committees on Human Research

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