Quality assurance

Pronunciation

Definition 1

A process that looks at activities or products on a regular basis to make sure they are being done at the required level of excellence. In clinical trials, quality assurance makes sure that all parts of the trial follow the law and the Good Clinical Practice guidelines. Also called QA. (NCI Dictionary)

Definition 2

Programs of regular assessment of medical and nursing activities to evaluate the quality of medical care including all actions taken to ensure that standards and procedures are adhered to and that delivered products or services meet performance requirements. (NCI Thesaurus)

Definition 3

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH] (NCI Thesaurus/CDISC)

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