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Date Posted: [OHRS to complete: mm/dd/yy]
Central IRB Status Page
DF/HCC Protocol #: [yy-xxx]
Central IRB Protocol #: [xxxxxxxxxx]
Central IRB Expiration Date #: [mm/dd/yy]
Important Cede IRB Review Information
The DFCI IRB has agreed to cede IRB review to [Insert Institution Name or NCI CIRB]
for this study. As a result the [Insert Institution Name or NCI CIRB] is responsible for the
regulatory oversight of this study.
Questions regarding Central IRB reviewed studies should be directed to OHRS at: (617)
632-3029 or email us at OHRSCentral_IRB@dfci.harvard.edu
Reporting Requirements to OHRS and DFCI IRB:
Please refer to the OHRS Information Sheet on Guidelines for Study Team Central IRB
Review (including the NCI CIRB).

Continuing Reviews will be conducted by the Central IRB: The study team
maintains responsibility for providing OHRS documentation of continuing review
approval from the External IRB. If continuing review approval is not provided
before the study expires, the study will expire and subjects will not be able to
start and/or continue the research at DF/HCC until current continuing review
approval is provided.

Amendments will be reviewed by the Central IRB: The study team maintains
responsibility for providing OHRS with all revised protocol documents approved
by the External IRB. These documents will be posted on OncPro by OHRS.
Revised documents must be provided to OHRS for posting within 30 days of
receipt from the sponsor and/or External IRB.

All Adverse Events, Other Events and Unanticipated Problems must be
Reported to the DFCI IRB: The DFCI IRB retains responsibility for the oversight
of all events occurring at participating DF/HCC sites related to Adverse Events,
Deviations, Violations, Exceptions and Unanticipated Problems. As a result, the
study team is required to follow all DFCI IRB reporting policies related to Adverse
Events, Deviations, Violations, Exceptions and Unanticipated Problems including
the collection and reporting of minor deviations and violations at the time of
External IRB annual approval submission.
Revised: 10.04.14