Human Investigation Committee/Human Subjects Committee
Expiration of Yale IRB Approval/Administrative Closure Summary Sheet 700 CH 2
Instructions for Principal Investigators: Please Return this checklist to the IRB as requested by the HRPP staff reviewer.
Protocol Number:Type here.
Protocol Title: Type here.
Principal Investigator: Type here.
Specific Protocol Information
Protocol Expiration Date:Tap for the calendar.
Protocol Submission Date: Tap for the calendar.
Duration of Current Lapse in Approval:Type here.
Brief Description of Study: Type here.
Risk Assessment:
Study qualifies as minimal risk ☐
Study is greater than minimal risk ☐
Study Status:
☐Administratively closed Date closed:Tap for the calendar.
☐Lapsed approval
Study Activity Since Administrative Closure or Expiration/Lapsed Approval
☐No subject enrollment has occurred
☐Actively enrolled subjects
☐Enrollment closed Date enrollment closed: Tap for the calendar.
☐Subjectsstill completing research interventions/interactions*:
☐Follow-up only (describe nature of follow-up):
☐Identified Data analysis only
☐De-Identified Data analysis only
*If applicable, did PI obtain IRB Chair approval to continue treatment of subject(s) during the expired period?
YES ☐ NO ☐
Was a Protocol Exception form (FR 22) submitted to the IRB Chair?
YES ☐ NO ☐
Reason for lapse of approval:Type here.
Was any part of the lapse attributable to the IRB? YES ☐ NO ☐
Has this study protocol approval expired previously? YES ☐ NO ☐
If YES, how many times? Type here.
Provide the information below for each lapse of IRB approval
Protocol Expiration Date:Tap for the calendar.
Protocol Submission Date: Tap for the calendar.
Duration of Lapse:Type here.
If your study is funded by an external source, please consult with your departmental business manager and the Office for Sponsored Projects (OSP) to confirm the accuracy of all funding sources and complete the requested information below.
Funding Source(s):Enter name of funding source and beginning and end dates. Provide source(s) of information, e.g., IRES. Specify whether funding from the source is in effect during each lapse period.
PI Name on Grant/Contract/Proposal / Funding Source/Yale Award/IRES PT # / Beginning and End Dates / Active or Not Active at time of expiration/lapse in approval or administrative closurePI Signature: Type here.
Date: Type here.
IRB Staff Reviewer Signature: Type here.Date: Type here.
Protocol Reapproval Date: Type here.
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Human Investigation Committee/Human Subjects Committee
Expiration of Yale IRB Approval/Administrative Closure Summary Sheet 700 CH 2
Revised: 21 June 2017