Study Closout


End of Enrollment Memo

Closeout Milestone Document

Please note that this milestone document is for use at Spokes/sites that enrolled at least one ESETT subject. Spokes/sites that did NOT enroll can close with their local IRBs (documentation provided under IRB Closeout Acknowledgment) and provide a final eDOA log, adding end dates for all study team members and are not eligible for any milestone payments.  

For spokes that enrolled at least one ESETT subject:

Closeout Milestone Activities


End of Study (EOS) PD Resources

Public Disclosure (PD) Menu of Activities


End of Study Primary Analysis slide set (NEW 1/8/20)


EOS PD Material Templates 


EOS PD Plan Examples (NEW 12/5/19):




The Regulations

21 CFR 50.24

FDA 50.24 Guidance 


Media Related Resources 

If a Reporter Contacts You 

Guidelines for Support Staff 

Tips for Working with the News Media (University of Michigan) 

ESETT Fast Facts