BRI IRB Full Closure Report

FULL CLOSURE REPORT
Submit two (2) sets of all documents, to the Research Protections Department (address in footer). Applications must be typed - no staples. Password to unlock form: “benaroya”.Contact the Research Protections Department with questions: [IRB_STAFF]
IRB Number: / VM/BRI funding #(s): / Date of Closure:
TITLE OF RESEARCH PROPOSAL (PROTOCOL TITLE):
Principal Investigator (PI): / Study Coordinator:
Dept & Mailstop: / Dept & Mailstop:
Phone: / Phone:
Email: / E-mail:
Address (if not VM/BRI): / Address (if not VM/BRI):
IRB Regulatory Contact(optional)
(if designating someone other than the study coordinator) / GCP/Ethics/FDS (IRB use) / Phone: / Email:
 /  / 
Dept. & Mailstop: / Address (if not VM/BRI):

Choose one and complete the appropriate section:

Was this a Cooperative study? (e.g. U of W or Fred Hutch Cancer Research Center is the IRB of record). Yes *No
* If “NO”, you cannot use this section. If YES, answer “a.” and “b.” below.
  1. Is this a Full Closure at BRI/VM –Subject(s) are Off Treatment, no Active Participation/Intervention with no Long-Term Follow-Up,AND no Data Collection/Analysis Continues at BRI/VM? (If “no”, you cannot submit this form.) Yes No
  • Date Effective: Total # of subjects (charts, samples, etc.) enrolled at BRI/VM: Total # of subjects (charts, samples, etc.) ever enrolled at all sites:
  1. Has the IRB of Record been notified of study closure at BRI/VM? (If “no”, cannot submit Full Closure.) Yes No
Provide documentation the IRB of record is aware of closure at BRI/VM; (e.g. date, name of contact):
Full Closure: No Subjects(or records, data, samples, etc.) ever Accrued at this Site.(NOTE: must be consistent with all previous Continuing Review Reports)
Full Closure:Subject(s) are Off Treatment(or no longer pulling records or collecting samples)AND no Active Participation/Intervention with no Long-Term Follow-UpAND noData Collection/Analysis Continues.
  • Date Effective: Total # of subjects enrolled at BRI/VM: Total # ever enrolled at all sites (if applicable):

Full Closure was reported to the IRB Office, but a final report/complete findings (and/or additional information) were not yet available and are now attached. Materials attached? Yes
  • Date Effective: Total # of subjects enrolled at BRI/VM: Total # ever enrolled at all sites (if applicable):

REPORT OF FINDINGS TO DATE:

Provide a written summary of your findings to date. (Note: If other findings/reports become available in the future, they must be forwarded to the IRB Office as soon as received.)
If the Report of Findings to Date is not available, please provide the date it will be submitted to the IRB:

IRB Submission Requirements:

Yes No / Do you want a confirmation receipt email for this submission sent to the PI and study coordinator?
Yes / 2 copies of all documents typed/word-processed (plus one tracked copy of any revised documents).
Yes / The VM Principal Investigator has signed the closure report.
Person completing this application: / PI Study Coordinator IRB Regulatory Contact Other: (cite below)
Printed Name: / Role in Study: / Phone#:

Signature of Principal Investigator: Date:

FINALINSTITUTIONAL REVIEW BOARD APPROVAL OF CLOSURE(IRB use only)
Name and Title:Signature: Date of Signature:
Approval Date: ______Review Date: ______Date reported on IRB minutes: ______
VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED
FWA00001994 (VMMC) / FWA00001995 (BRI) / IRB00000057

Benaroya Research Institute at Virginia Mason Institutional Review Board (BRI/IRB)Version 3.6 – Rev. 10/30/15

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