Data Standard

Data Standard

USA: FDA’s Framework for Real-World Evidence Program – Glossary- a set of rules about how a particular type of data should be structured, defined, formatted, or exchanged between computer systems. Data standards make submissions predictable, consistent, and have a form that an information technology system or a scientific tool can use (as per Framework for FDA’s Real-World Evidence Program – Glossary).

China: Key Considerations in Using Real-World Evidence to Support Drug Development – A set of rules on how to construct, define, format, or exchange specific types of data between computer systems. Data standards allow the submission of information to be predictable and consistent, and in forms that information technology systems or scientific tools can use (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)