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Your First Application to the GCRC
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Submit an Application
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.
Here are the steps to make an application to the GCRC:
If you've never applied to the GCRC before, read this overview
first
"Your First Application to the GCRC" includes an overview
of the application process, including the scientific review and how we can help you develop
your protocol. There's even a flowsheet outlining the process!
Select an application form
Select the appropriate application forms for the center where you plan to conduct your study.
Forms are in the table below.
Normally, you should
apply to the center where you plan to see subjects. However, if your study proposal involves
research subjects under 18 years of age (with the
exception of infants who are involved in a study of their mothers), then you must apply
through the Pediatric CRC so that the Pediatric Scientific Advisory Committee may review
your study, regardless of where you plan to perform your research.
Requirements for Industry-Sponsored Studies
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Downloadable Application Forms |
General Clinical Research Center at UWMC
Due on the 1st of each month
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Required Forms:
You must submit a study protocol with your application.
The GCRC requires a protocol for every study so that GCRC clinical staff (nurses, techs, etc.)
can understand the procedures a subject will experience, research procedures can be performed
to the investigator's specifications, and so consent requirements can be met accurately. If you
do not have a study protocol prepared
here is a template for your use.
You can submit your GCRC application before you receive approval from your IRB or the
UW Human Subjects Division.
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Optional Forms:
GCRC Application Appendices:
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Modification to approved GCRC Studies
Requests for changes in ancillaries and/or core services and/or an increase in the number of
subjects must be reviewed and voted on by the SAC. This requires a Modification Memorandum
and the resubmission of the study application with appropriate sections revised indicating
the changes (highlighted). The Modification Memorandum and application must be submitted by
Friday before the regularly scheduled SAC meeting (3rd Thursday of each month).
The SAC Chair and the GCRC Administrative Director can approve requests that are not
substantive (ancillaries <$500 and/or minor impact on services).
Please address the Modification Memorandum to the SAC Chair,
William Hagopian, MD, and the Administrative Director,
Toni Long, and email to
gcrc@u.washington.edu.
Please use this Modification Memorandum template.
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Pediatric Clinical Research Center at Children's Hospital
Due on the 10th of each month
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Use the combined
IRB-SAC application form. The documents are submitted to both the IRB and PCRC.
Further information on the document can be found on the Forms and Instructions page
at CHRMC IRB's web site.
GCRC cores: To request use of the GCRC's
specialized cores at the UW Medical Center, submit the standard GCRC Core appendix
with your Pediatric CRC application (download the forms above).
You must submit a study protocol with your application.
If you do not have a study protocol prepared here is a template for your use.
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Contact our faculty & staff for assistance with the application
Key people:
- Biostatistician for help on study design.
- Research Subject Advocate for help with a Data Safety Monitoring Plan. All protocols on the GCRC are required to have a DSMP.
- Administrator for help with budget planning. Budget planning depends to some degree on Study Categorization.
- Core Managers if you plan to use one of our specialized cores. We encourage you to contact the Core Manager as early as possible, ideally while you're preparing your primary grant application to the NIH or other peer-reviewed funding agency.
Click here for contact information
and a selection of topics we can help with. Please contact us as early as possible.
Submit your application for scientific review
The Scientific Advisory Committee (SAC) meets every month. During the SAC review, each study
is classified into one of three categories developed by the national GCRC program. Study
categories depend on the type of research being performed and they determine the level of
funding we can provide for clinic and testing costs, including
ancillaries.
Please feel free to consult our Administrative Staff about study category while you are
drafting your application.
Category A studies are studies in which
subjects are admitted for research purposes
only, when hospitalization would otherwise not be necessary and no health
advantages are expected to accrue as a result of the hospitalization or visit. This
category also includes protocols that are investigator-initiated. For these studies,
we can provide many services for free or at significantly reduced
rates.
Category B studies are studies in which
subjects are admitted for both research and routine diagnostic or therapeutic
purposes. Ancillary costs related to research
are covered by the GCRC. Costs for diagnosis and treatment according to established
standards of care are billed to the patient or third-party coverage.
Category D studies are industry-initiated.
As an academic center, our priority is to service studies whose funding sources are
from non-profit organizations such as the NIH. Charges for these studies are paid
directly by the drug company or industrial sponsor. To learn more about our policy
on industry-sponsored studies, including special cases for which these studies would
qualify for classification in either Categories A or B,
click here.
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The review committee decides whether to approve your application
Decisions are usually sent out within a week of the SAC meeting. There are four possible
decisions:
When an application is approved, we contact
you with instructions on how to get started.
An application is approved with contingencies
when the SAC has questions and concerns and requires additional information from the
investigator. Please contact us if you have questions or concerns. Every effort
is made to review PI response letters and revised applications in a timely fashion.
An application is tabled when the SAC
determines that there are significant concerns, sufficient to preclude an adequate
evaluation of the application. A tabled application must be resubmitted for
review by the entire Scientific Advisory Committee. If the application is resubmitted
for the following month's SAC meeting, the submission deadline is extended one week.
If the application is resubmitted at a later time, the usual deadline applies.
Applications are disapproved when the proposal
lacks sufficient scientific merit or when a specific need for the GCRC cannot be
identified.
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As always, contact us if you have any questions!
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