Study Closure

Investigators are responsible for closing out the study when the research is complete.

Timing: Investigators must submit a study closure file once a study is complete.

How do I start a study closure form?

On the study assistant dashboard, select Forms on a study in Approved Status.

Select “IRB Study Closure Form” to open the online reportable event submission form.

Clipping of iRIS showing study closure window

A study can be closed once all of the following occur:

Subject recruitment has concluded (i.e., no participant recruitment is in progress or anticipated)
All subject specimens, records, and data have been collected (i.e., no further collection of data/information from or about living individuals is needed)
All interactions or interventions with participants are completed (i.e., no further contact with the subject is necessary or anticipated)
Analyses of identifiable subject data, records, and specimens are finished (i.e., use of or access to identifiable subject data is no longer necessary).