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This document describes the definitions for protocol registration data elements submitted to ClinicalTrials. These definitions are mostly adapted from 42 CFR Part Data element entries are annotated with symbols to indicate generally what information is required to be submitted and under which circumstances. The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials. Note : The term “clinical study” is used to refer to both interventional and observational studies.

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