Study Status Guidance

Study Status guidance is now available on the HRPO website under the A to Z guidance,

Regulatory requirements determine which activities may be done in a particular study status. Consult the guidance at each renewal submission and modification submission to ensure that the correct status is being selected.

Analyses on collected samples/specimens CANNOT take place if the study status is "permanently closed to additional enrollment and subjects have completed all required research activities but the research remains active for long-term follow-up of subjects" or "the ONLY research activity is data analysis". 

Study status must be either "open to additional subject enrollment" or "permanently closed to additional enrollment but subjects continue to undergo research-related activities" in order to continue to run analyses on collected samples/specimens.

Please contact with questions.