<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>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, QA makes sure that all parts of the trial follow the law and the Good Clinical Practice guidelines.</n0:def-definition><n0:def-source>NCI-GLOSS</n0:def-source></n0:ComplexDefinition><n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>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]</n0:def-definition><n0:def-source>CDISC</n0:def-source></n0:ComplexDefinition>
<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>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.</n0:def-definition><n0:def-source>NCI</n0:def-source></n0:ComplexDefinition>