The term 'participant' is used to refer to human subjects. Note: The term 'clinical study' is used to refer to both interventional and observational studies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials. The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. These definitions are mostly adapted fromĭata element entries are annotated with symbols to indicate generally what information is required to be submitted (and under which circumstances). This document describes the definitions for protocol registration data elements submitted to for interventional studies (clinical trials) and observational studies.
Protocol Registration Data Element Definitionsįor Interventional and Observational Studies
