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):

Kentucky 

Texas

 

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