Venkataramana Kandi^1,, Sabitha Vadakedath¹

Clinical research is a way of doing research that is primarily aimed to solve a human health and/or ailment-related problem. However, clinical research is complex and involves factors that influence the accuracy of the study results. The clinical research-related documents and data management assumes increased significance. The data obtained from the clinical research is collected, stored, validated, distributed, analyzed, and managed according to standard recommendations as prescribed by the national and international regulatory agencies. The nature of the case record form, the data validation process, quality assurance during data collection, validation, database creation, pharmacovigilance, the role played by the regulatory authorities, and other aspects of clinical trial data management are discussed comprehensively in this review.

clinical research, human health, data management, case record form, regulatory agencies, pharmacovigilance