1. "Why should I apply for GCRC help,
or what can the GCRC do for me?"
The GCRC can provide you with nursing and dietary services, statistical
consultation and data management, and funds for research-related hospital
costs.
2. "How do I apply for GCRC support?"
Please contact UW-GCRC Administrator Paulette Sacksteder,
phone 263-3271 or e-mail pasacksteder@wisc.edu
for information on the application process.
3. "Can I apply for a GCRC grant even though I
do not have extramural funding?"
The GCRC does not award grants. While the GCRC gives first priority
to clinical grants with NIH support, faculty and staff investigators
without extramural funding can submit a protocol requesting usage
of our resources.
4. "Do certain types of protocols have a better
chance for UW-GCRC support?"
Yes, protocols with NIH funding have first priority, according to
the GCRC NIH grant. Other considerations are:
- Scientific and research merit
- New investigator seeking NIH funding
- Researcher need for the GCRC
- Clinical research area
- Important research funded by pharmaceutical company
- PI-initiated protocol.
5. "What will the GCRC pay for?"
This depends on the study and whether it is supported by other funding.
Because of a significant reduction to our grant award in 2004, we prioritize support for
NIH-funded studies and can pay for room and board, nursing services, dietary services,
sample processing, biostatistical and informatics services. Coverage of hospital-provided
ancillary services (e.g., laboratory, CXR, ECG, research medications) can also be provided
with a limit of $100 per inpatient day and $33 per outpatient visit (discounted cost).
Studies are assigned an annual total limit for ancillary services.
Projects that have other sources of non-industry funding (e.g., foundations, associations)
are reviewed on a case-by-case basis for payment for room and board and nursing services,
support, but are expected to cover all ancillary services with their study funds.
We do not pay ancillary services or room costs for industry-initiated studies,
although we consider those studies for our center, utilizing our expert nursing and other services.
For all funding sources, study-specific equipment and supplies (i.e., those not already on the GCRC or provided through UWHC) should be provided by the investigator.
Please contact Danielle Gale (dgale@biostat.wisc.edu) for more information."
6. "Do I have to write an admission and discharge
note on these resources?"
Yes, these notes need to be provided for inpatients and appropriate
Hospital-required notes need to be provided for outpatients as well.
The PI of the study or a co-investigator of the study needs to be
an MD with UW Hospital admitting privileges.
7. "Will the GCRC cover the cost of lab tests?
equipment? supplies?"
See the response to #5 above.
8. "Can I apply to GCRC before I get IRB
approval?"
Yes. But investigators must have final written IRB approval before
the study can be activated on the GCRC.
9. "Will I work with one GCRC nurse or several
nurses?"
Our practice has been to assign two nurses to each protocol; one
of those nurses is usually the lead nurse. These two nurses will work
with the study's PI to facilitate the implementation of the protocol
with the other nursing staff in our center.
| Ancillary Services |
Services routinely available from hospital departments
for all patients in the hospital; i.e., routine blood and urine
tests, x-rays, medications, etc. |
| Clinical Trial Agreement |
An agreement with an industrial sponsor that contains
the research project; budget; and terms and conditions affecting
proprietary information, data rights, publication rights, inventions
and patents, and payment schedules and conditions. The agreement
is signed by the principal investigator, a representative from the
UW Research Administration - Financial office, and the sponsor. |
| Core Laboratory |
A facility that supports ongoing sophisticated clinical
research and the development or validation of new methods for this
purpose. The UW-GCRC does not currently have a core laboratory,
but does have its own processing lab. |
| Industry-Initiated Study |
A study initiated by an industrial sponsor with little
or no research aims added by a UW investigator. Usually these studies
are conducted in multiple institutions. |
| Inpatient Day |
One person registered as a UWHC inpatient at 12:00
midnight. |
| NIH Guidelines |
The rules and regulations that define and govern the
UW-GCRC. Published by the National Center for Research Resources
of the National Institutes of Health. |
| Outpatient Visit |
One person registered as a UWHC outpatient who arrives
at and departs from the hospital or clinics within a single day
before midnight. |
| Patient Categories |
NIH's method of assigning financial responsibility
of hospital costs for patients receiving UW-GCRC support. See pages
17-21 for further explanation. |
| - Category A: |
Patients admitted solely for research purposes. In
cases where all subjects would be category A, the study may be called
a category A study. |
| - Category B: |
Patients admitted for routine medical care and who
simultaneously participate in a research project. |
| - Category C: |
Patients admitted but who do not participate in any
research project. These patients are typically called "boarders"
on the UW-GCRC. |
| - Category D: |
Patients who participate in industry-initiated studies.
These studies are typically called category D studies. |
| PHS 398 |
Except for minor exceptions, Public Health Service
(PHS) form #398 is used to apply for all new, competing continuation,
and supplemental research and research training grant and cooperative
agreement support from NIH and other agencies of the PHS. |
| Scatter-Bed |
Some studies require that patients be cared for in
areas away from the discrete unit, referred to as scatter-beds.
Currently, the UW-GCRC has NIH authority and funds to support studies
at the UW Children's Hospital, and at the Perinatal Center in Meriter
Hospital/Park. |
