CLOSURE REQUEST

version February 2025

 
 
 

Name and credentials

 

Include email address of PI or knowledgeable designee

 
 
 

Enrollment breakdown

Enter the total number of enrollees for each ethnic group below

 
 
 
 
 
 
 

Specify ethnic group in space below

 
 

Vulnerable populations

select each group that was part of this project

 
 

ATTACHMENTS

*Note special requirements for HUD/HDE and Registry projects

 
  • Abstracts resulting from conduct of the research/project
  • Email(s) addressing status of outstanding items found during audits or monitoring visits
  • DSMB/DMC/Ethics Board, etc... report/approval since last renewal review
  • FDA/OHRP/NIH, audits (internal and external) and/or progress reports
  • Publications resulting from conduct of the research/project
  • Relevant reports in recent literature
  • Reportable events log
  • Sponsor support of study closure, sponsor annual reports, or sponsor monitoring visit reports
  • Summary/short narrative of conclusions when requesting closure
  • HUD/HDE projects: Summary of clinical outcomes
  • Registry projects: list of individual projects conducted under the registry
 

Do NOT click the “Submit” button below. Instead select the print option, save the form, as a PDF, then include the form with the materials for submission to ORS@piedmont.org or to be uploaded into IRBNet.