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Important Information About Changes to the GCRC Application and Scientific Review Process
The scientific review process is being centralized under the Institute for Translational
Health Sciences (ITHS), the new federal funding for the clinical research centers at UW
and Children's (click
here for more info). Beginning in February, investigators will submit their
applications to the ITHS rather than to either the adult or pediatric SAC. The ITHS will
then distribute the applications to each SAC. The review process will become much simpler
and more streamlined for investigators. The University of Washington SAC will not change
membership, leadership, or structure.
We will be posting the contact information and instructions for SAC application
submission to the ITHS as soon as it becomes available. In the meantime please continue
to submit your applications to the GCRC@u.washington.edu.
As well, there will be no meeting of the Scientific Advisory Committee (SAC) for the
General Clinical Research Center in January, 2008, as we will be transitioning the unit to
the Institute of Translational Health Sciences. The next meeting will be in February,
2008, with applications due February 1, 2008. If this delay causes a significant hardship
for you please contact the GCRC administrative director,
Toni Long,
and we may be able to arrange an ad hoc review. We apologize for this inconvenience.
Your First Application to the GCRC
Welcome!
This is a quick introduction to the initial process of having a protocol accepted to be
conducted on the GCRC.
The application process to the GCRC involves a scientific review. There are many benefits to
conducting studies on the GCRC and we use the scientific merit of the application to help us
prioritize our resources. Our scientific review is performed in the style of the National
Institutes of Health. We evaluate the significance of
the work proposed, the innovation of the study, and the
validity of your approach.
PIs are welcome to attend the portion of the meeting during which their application is
discussed. Please contact us in advance.
After the review, we may suggest changes that need to be made to the study before it can be
accepted. Once you get your review back, please contact and work with us if you have any
questions or concerns.
Let us help you make your application a success.
We can start by helping you with your protocol. We have two resources you should use before you
even apply to the GCRC while you are writing your protocol.
The first is a GCRC/PCRC
biostatistician to help you with the design of your study. The biostatistician will work with you to
create the plan that produces the best chance of your study producing solid evidence to elucidate your
scientic questions.
The second resource is our Research Subject Advocate (RSA) Program. All
clinical trials or studies using human subjects require an assessment of risk of the study and
a plan to ensure patient safety. That plan may be very simple for low risk studies such as
simple blood draws. However, for high risk studies such as potentially toxic new therapies
to treat a serious disease, the plan must be more extensive. Regulatory agencies have suggested
types of components that need to be in each plan and we can help you assess your protocol and
put together a Data and Safety Monitoring Plan (DSMP). Please
contact our RSA to talk about a DSMP as you write your protocol and before you submit your
GCRC application.
We offer many more services, summarized on the
"For Investigators" page (link at the end of this page). If you want to use any of
the services such as the Body Composition Laboratory, Gene and Cell Therapy Core Laboratory,
or the Informatics Core, please contact the managers of these cores and meet with them prior
to submitting your application. They can help you fill out the information you need to
facilitate a more rapid review.
So, let's get started! Remember most pages have a
Quick Help menu with a phone number that will connect you
to one of our faculty or staff. Please call us with any questions or concerns as you work through
this process. We look forward to working with you on your GCRC application and hope this is the
beginning of a long and productive clinical collaboration with you.
Click here for application forms
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