Abstract
Clinical quality assurance (CQA) is an independent function whose primary responsibilities are to assure that the evaluated activities were appropriately conducted and the data were generated, recorded, analyzed, and accurately reported according to protocol, standard operating procedures (SOPs), and good clinical practices. This is done through the performance of systematic and independent examinations/audits of all trial-related activities and documents. Therefore, the CQA unit is an essential building block (capacity component) of a well-designed, sufficiently capable, and sustainable clinical trial program. This chapter discusses how quality in clinical research should be developed and implemented with the objective of ensuring data integrity and the safety of humans involved in clinical research studies. It also includes useful information such as a list of SOPs that all CQA functions should have at their disposal and tables that include information to be covered during some specific types of clinical quality assurance audit.
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