Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Glossary Definition

The date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected. Whether the clinical study ended according to the protocol or was terminated does not affect this date. The "estimated primary completion date" is the date that the researchers think will be the primary completion date for the study. The primary completion date is the term used on for "completion date" defined in Section 801 of the Food and Drug Administration Amendments Act of 2007. (See also Primary Completion Date data element on