Quality of real-world registry studies.

Registry studies are types of real-world studies (RWS), which are used to generate clinical evidence regarding therapeutic use, potential benefits, or risks of a medical product in real-world medical practice, and to support regulatory decisions. RWS are conducted using real-world data (RWD), which are collected for patient care management, but not collected in compliance with good clinical practice standards for documentation. Hence, ensuring data quality, integrity, and reliability for studies using RWD is difficult. It is important to ensure the quality of research, data, and evidence during the planning and conduct of registry studies. This brief review discusses the elements critical to ensuring quality during planning and reporting of RWS.