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Continuing Review
applications should be received no later than six weeks prior to
the study's expiration date. Please be aware that no new
participants may be enrolled in the study after the expiration
date. Additionally, research-related procedures or
activities involving existing participants may not take place
without written authorization from the HRPO.
The following
information is intended for renewal submissions for greater than
minimal risks research studies. If your study is minimal risk
and qualifies for expedited review, please see the
Forms page for
expedited review submissions.
If you are not sure
whether your study involves minimal or greater than minimal
risk, please call the HRPO office at 633-7400.
Click a link below to view information:
Application
Requirements
Meeting
Dates and Deadlines
Instructions
Forms
Appendix Forms
Sample/s/Examples
Helpful Information
Application Requirements
The following materials are required of
all renewal applications that require Full Board Review.
Any applications that do not meet the following criteria will be
sent back to the PI without being reviewed.
- Four (4) complete copies.
- original for HRPO records
- two (2) copies; one for each primary reviewer
- one (1) copy for the
Billing Matrix
- A completed Form 7
including all signatures, spell checked, and typed
- All appendix forms that
are relevant to your study
- Most current
version of the protocol that includes: background
information, objectives, inclusion/exclusion
criteria, treatment plan, a description of the data
monitoring committee or plan and follow-up procedures.
Note: Protocols
must be submitted with each application regardless of
whether any changes have occurred to the protocol.
- Unstamped consent (if being revised at the time of
renewal, highlight changes in yellow): written consent,
verbal script, materials for implied consent or waiver
application, Form K1. Copy of consent form(s) on the most
current version of the HRPO form in a standard 12 point
font.
- Current, most recently reviewed consent(s) with HRPO
approval stamp.
-
For grant funded
studies: progress report or cumulative cooperative group
progress report
-
Data monitoring progress report and/or statement from the
PI, sponsor or cooperative group that all AEs and SAEs have
been monitored within the past 12 months and no safety
concerns or other problems have been identified (or, if
safety concerns have been identified, provide a summary of
actions taken in response.)
If applicable, please
submit:
- Certificate of
Confidentiality unless covered by a blanket COC
-
Copies of any
publication(s) to date that have resulted from the research
and were not previously submitted
- Copy of the relevant literature
- Cumulative
Unanticipated Problem Report
-
Most recent Outside
Audit/Monitoring Report
-
Most recent
Multi-Center Trial Report
-
PRMC Approval stamp on
front page of Form
7
-
Revised Questionnaires
(highlight changes in yellow and only submit those pages
that have been revised)
-
Recruitment Materials
(if being revised at the time of renewal, highlight changes
in yellow.)
-
RDRC number
Instructions
Forms
Note: Forms on this page are only available
in Rich Text Format (.rtf). For forms in Word format
please visit the All Forms
page.
Appendix Forms
Samples/Examples
Helpful Information
Please note that the Continuing Review Committees (CRC) limit
the number of renewals per meeting.
All renewals are scheduled on a first come, first serve basis.
Those studies exceeding the limit will be notified that the study
will be scheduled for the next available meeting.
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