FAQ and Glossary
1. Why should I apply for CTRC help, or what can the CTRC do for me?
2. How do I apply for CTRC support?
3. Can I apply for a CTRC grant even though I do not have extramural funding?
4. Do certain types of protocols have a better chance for UW-CTRC support?
5. What will the CTRC pay for?
6. Do I have to write an admission and discharge note on these resources?
- Why should I apply for CTRC help, or what can the CTRC do for me?
- How do I apply for CTRC support?
- Can I apply for a CTRC grant even though I do not have extramural funding?
- Do certain types of protocols have a better chance for UW-CTRC support?
- Scientific and research merit
- New investigator seeking NIH funding
- Researcher need for the CTRC
- Clinical research area
- Important research funded by pharmaceutical company
- PI-initiated protocol
- What will the CTRC pay for?
- Do I have to write an admission and discharge note on these resources?
The CTRC can provide you with nursing and dietary services, and funds for research-related hospital costs.
Please contact CTRC Protocol Manager Danielle Gale (phone 262-3005, e-mail ) or CTRC Administrator Paulette Sacksteder, (phone 263-3271, e-mail ) for information on the application process.
The CTRC does not award grants. While the CTRC 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.
Yes, protocols with NIH funding have first priority, according to the CTRC NIH grant. Other considerations are:
This depends on the study and whether it is supported by other funding. We prioritize federally-funded studies and can pay for room and board, nursing services, dietary services and 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 CTRC or provided through UWHC) should be provided by the investigator. Please contact Danielle Gale ( ) for more information
Yes, these notes need to be provided for inpatients and appropriate Hospital-required notes need to be provided for outpatients as well. (Refer to specific Hospital Policies) The PI of the study or a co-investigator of the study needs to be an MD with UW Hospital admitting privileges. All inpatient studies require a patient history and Physical (H&P) per hospital policy.
Glossary
| Ancillary Services | Services routinely available from hospital departments for all patients in the hospital; i.e., routine blood and urine tests, x-rays, ECGs, 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 CTRC does not have a core laboratory on the unit. but has its own sample 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 | A subject who is on the CTRC at 12:00 midnight. |
| NIH Guidelines | The rules and regulations that define and govern the CTRC. Published by the National Center for Research Resources (NCRR) of the National Institutes of Health (NIH). |
| Outpatient Visit | A subject who arrives at and departs from the CTRC before midnight, with a visit length of < 10 hours. A subject with a visit expected to be 10 or more hours in length needs to be submitted as an inpatient admission, and the subject should be admitted to the CTRC the night before the study visit. |
| Categories | NIH's method of assigning financial responsibility of hospital costs for studies receiving CTRC support. |
| - Category A: | Strictly research or a combination of research and routine care, where the majority of the visit is for research purposes
(CTRC inpatient room/outpatient nursing and research-related charges paid by CTRC |
| - Category B: | Research and routine care; CTRC inpatient room/outpatient nursing charges paid by insurance, research-related charges paid by CTRC or study funds |
| - Category C: | Patients are being seen on the unit but are not participating in a research project; these patients are typically called "boarders" |
| - Category D: | Study is industry-initiated and funded, including patient care; CTRC inpatient room/outpatient nursing and research-related charges are paid by industry funds |
| PHS 398 | Except for minor exceptions, Public Health Service (PHS) 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. |
| Satellite Locations | Some studies require that patients be cared for in areas away from the main CTRC unit, referred to as satellite sites. Currently, the CTRC has authority and funds to support studies at the American Family Children's Hospital, Meriter Hospital, and at the Newborn Intensive Care Unit at Meriter Hospital. |
Publications arising from any research project receiving support from the CTRC, regardless of funding source, should acknowledge support by stating:
"Supported by grant U54RR024377 from the Division of Clinical Research Resources, National Center for Research Resources, National Institutes of Health"
