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These findings underscore the necessity of research to provide an evidence base for monitoring practice.

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials.

Recently, regulatory bodies have published guidance related to this topic. 2-7 A common thread among these various documents is an emphasis on risk-based approach to data management, specifically targeting data and study procedures that are critical and have the greatest impact on maintaining subject safety and determining product efficacy. For example, the Medicines and Healthcare products Regulatory Agency (MHRA) Good Practices (GXP) Data Integrity Guidance and Definitions document discusses the data lifecycle, data governance, and other organizational culture features to be considered in a risk-based approach. 2 An open reporting culture in organizations should be encouraged as fundamental to data integrity promotion throughout the data lifecycle, including processes from generation or recording of data to destruction, if needed, and the intervening processes (Figure 1).