Form 52 reviewer Worksheet ER ClosureWksht

REVIEWER WORKSHEET
Expedited Study Closure Review

OMB #0925-xxxx Expiration Date: xx/xx/xxxx
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STUDY ID:
STUDY TITLE:
PROTOCOL VERSION DATE:
CIRB EXPIRATION DATE:
NAME OF CIRB REVIEWER:
ROLE:

Chair

Vice Chair

Designated Reviewer

DATE REVIEW COMPLETED:
DATE STUDY CLOSED TO ACCRUAL:

1.

Indicate the documents reviewed (check all that apply):
Updated NCI Adult/Pediatric CIRB Application for Continuing Review indicating
Status of “Completed” or “Administratively Completed”
Study Protocol
CIRB’s Version of the Consent Form(s) (if applicable)
Cooperative Group Model Consent Form(s)
CIRB-approved Translated Consent Form(s)

Version 11/14/14

DSMB/Safety Monitoring Committee report
Toxicity Summary
Presentations or publications for the study
Final Study Report/Publication
Other, please specify
2.

Verifying Study Status
Studies may be permanently closed with the CIRB if they have a status of “Completed”
or “Administratively Completed.” Select either A or B below and check the boxes to
verify the requirements for that status in the submitted Continuing Review Application.
A. Completed – Section 1.1.8 of the Continuing Review Application
Definition: The study is considered completed with the CIRB only when all of
the following are true:
The study has been closed to accrual.
All participants have completed study intervention.
All participants have completed all follow-up activities.
Analysis of the data is complete.
The study has met its primary objectives and a final study report/publication
has been submitted.
B. Administratively Completed – Section 1.1.9 of the Continuing Review
Application
Definition: The study is considered administratively completed with the CIRB
when it has been stopped earlier than planned and all of the following are true:
The study has been closed to accrual.
All participants are no longer receiving study intervention.
All follow-up activities have ceased.
No further activity or data analyses are being performed.

3.

Determination:
Approve the permanent closure of the study with the CIRB.
Forward for review by the convened CIRB (provide reason in Question 4)
Reviewer requests additional information before a determination can be made
(provide additional information requested in Question 4)

4.

Comments:

Version 11/14/14