What defines “quality” within the framework of clinical research? To answer this question, one has to step back and start with the definition of “quality” per se. Universally, quality is defined as the degree to which a set of inherent characteristics of a product fulfils requirements and “inherent”, as opposed to “assigned” means existing in the product. Amer Alghabban, the author of The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance amongst others analyses clinical quality management system.
Extract:
‘Clinical Quality Management System (CQMS): A Framework for Operational Excellence and Compliance with Good Clinical Practice (GCP)’
What are the quality “requirements” within the universe of clinical research? In the clinical settings, these are the applicable clinical research standards, regulatory requirements, and customer requirements as well as guidance and industry-wide practices and all these applicable requirements include the need for a Quality System (QS). Who are the “customers” in clinical research? Essentially, the “customer” can include the regulatory authorities, other clinical researchers and institutions, health insurance entities (governmental and/or private) and, most importantly, the public at large.
What is the product of clinical research? In general, a product is an output from a process and the output from the clinical research process is “information”. Hence, for clinical research, the “inherent characteristics” need to be built in the clinical research system and its component processes (clinical trials) in order to produce the “correct information”; accurate, reproducible, reliable data with integrity and without errors that matter.
Therefore, for the research to produce “quality” results, it needs to have a Clinical Quality Management System (CQMS). Fundamentally, a quality system (QS) is a set of policies, processes and procedures required for planning and execution (production/development/ service) in the area of an organisation (i.e., areas that can impact the organisation’s ability to meet customer requirements)1, and for verification that the “requirements” are being fulfilled.
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