IMPORTANT NOTICE:
The GCRC has been replaced by the new CTSI. As the CTSI gets established some of the procedures below may no longer be valid. The IRB is working with the CTSI to integrate our review procedures to make the process as streamlined and efficient as possible.
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The
CTSI is an NIH funded center charged with advancing
medical knowledge in a clinical setting. The
CTSI provides a variety of resources to researchers who
choose to conduct their research in the center.
Researchers
who wish to conduct their studies with the CTSI must submit their project separately to both (1)
the IRB and (2) the CTSI. When doing so you must submit
the same exact IRB paperwork to both committees.
If one committee requests any changes you must make
the same exact changes to the paperwork submitted
to the other committee.
After the initial protocol approval the investigator is responsible for sending a copy of all future IRB approved submissions (revisions, adverse events, continuing review, etc) to the CTSI.
Please
note:
-
BEST PRACTICE: Work with the CTSI to coordinate the review of your project through the CTSI and IRB.
- A
knowledgeable representative from your study must
attend the IRB meeting to assist the Board with
their review of the project.
- You
may choose to submit via a "harmonization process"
and wait until after the IRB meeting and reply
to all requests at one time. This is simpler for
the investigator, but will definitely mean it
will take a little longer for your project to
be reviewed.
- If
you are unable to make all of the changes requested
at the intermediate steps in the process you may
choose to wait until after the IRB conducts it's
review. Pro = only correct and copy paperwork
one time. Con = will result in longer amount of
time to have project approved.
-
You are not required to submit to one office before another - you may submit your project to
either committee at any time. However you must
remember that (1) you cannot start your project
anywhere until you have IRB approval, and (2)
you may not start your project in a CTSI CRU
until you have approval from both offices/committees.
Prior
to submitting any paperwork to the CTSI
or IRB you should visit their web site at https://www.ctsi.ufl.edu/.
