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Macro- and Micro-Validation: Beyond the ‘Five Sources’ Framework for Classifying Validation Evidence and Analysis

Authors

Paul E. Newton

DOI

https://doi.org/10.7275/f75k-1y75

Abstract

This paper argues that the dominant framework for conceptualizing validation evidence and analysis – the 'five sources'framework from the 1999 Standards – is seriously limited. Its limitation raises a significant barrier to understanding the nature of comprehensive validation, and this presents a significant threat to effective validation practice. Motivated by a belief that 'validity by design' ought to be substantiated through 'validation of design' this paper demonstrates the importance of adopting a broader conceptual framework. It introduces a new framework, based upon the metaphor of different validation lenses through which to scrutinize assessment procedures at differing levels of detail, with micro-validation lenses at one end of a continuum and macro-validation lenses at the other. The evolution of validation theory can be seen as a very gradual, if somewhat reluctant, acknowledgement of the importance of micro-validation. This paper recommends micro-validation as the natural foundation for any comprehensive validation program. Accessed 4,156 times on https://pareonline.net from December 07, 2016 to December 31, 2019. For downloads from January 1, 2020 forward, please click on the PlumX Metrics link to the right.

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