CLOSURE REQUESTversion February 2025

CLOSURE REQUEST

version February 2025

IRBNet ID number and full study title*

Principal Investigator*

Name and credentials

Email contact information*

Include email address of PI or knowledgeable designee

Project type to close*

Select or enter value

Attestations for permanent closure*

Select or enter value

Enrollment breakdown

Enter the total number of enrollees for each ethnic group below

African American

American Indian

Asian

Caucasian

Latino

Native Hawaiian or other Pacific Islander

Other, specify

Specify ethnic group in space below

specify

select each group that was part of this project

Group*

Select or enter value

*Note special requirements for HUD/HDE and Registry projects

Documentation to attach to submission, when applicable

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

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