Most studies require approval from a human subjects review board. If your study requires approval, you may register your study on prior to getting approval if the Overall Recruitment Status of the study is Not yet recruiting (see Overall Recruitment Status data element on

If a study requires human subjects review board approval, approval must be obtained before the study's Overall Recruitment Status is changed to Recruiting. When board approval is obtained, please update the Protocol Section of the study record in the Protocol Registration and Results System (PRS) and Release (submit) the study for processing.

See How to Register Your Study and How to Edit Your Study Record for more information.