Data Management in Emergency Response Research.

Proper data management is essential for ensuring the validity and quality of clinical research, a key aspect of good clinical practice (GCP) guidelines and a requirement of research ethics committees and regulatory authorities. Thoughtful planning, validated data management tools, and standardized operating procedures are fundamental to ensure quality research data and essential to rigorous analysis, sound results, and reporting and sharing study conclusions. This chapter focuses on clinical research as the most data-intensive type of research, but the principles and practices outlined also apply to other types of research. We introduce key concepts using examples from emergency research studies, rather than attempting to provide an exhaustive technical overview.

Data management is more than the development of a study database or the mere collection and maintenance of study data; nor should it simply be considered as information technology (IT) or data analysis. It refers to a series of processes and activities during the study but also before and after the collection of data. Essential elements include precautions to protect the rights, privacy, and safety of research participants and their communities. Data management is thus a key task in emergency clinical research, and there must be sufficient resources to ensure adherence to GCP guidelines, governmental regulations, and data management standards and to support timely reporting of high-quality research results. Unfortunately, good data management is often not given the priority needed to ensure regulatory-level, interpretable results.