All requirements to activate the pilot grant award are outlined in the Notice of Selection (NOS) letter sent in late February. Investigators may avoid delays in receiving award funds by executing all pre-award requirements (i.e. regulatory approvals)
in a timely manner. Principal Investigators should report monthly during the pre-award period to CCTSI administration regarding progress toward completion of all pre-award requirements.
Routing Award Funds
CCTSI Pilot Grant Program awards are considered internal awards, so CU-Denver PIs are not required to obtain approval from the Office of Grants and Contracts (“Routing”) prior to receiving a CCTSI Pilot Grant award. However, PIs from CCTSI Affiliated Institutions may be required to complete an internal review process at their organization prior to receiving a CCTSI Pilot Grant award (notably
CU-Boulder). Contact your department’s financial administrator for details.
CCTSI will set up the primary award spending account at the PI and/or Co-PI’s institution. Speedtypes and spending account number(s) are included in the Notice of Award (NOA). The financial administrator in the PI’s home department can further
route funds to purchase orders, vendors, MSA/GO accounts at CHCO, etc. Indirect costs (F&A) are added to the award by CCTSI only under very specific circumstances.
Award funds are distributed only after CCTSI has received documentation of required institutional and/or federal regulatory approval noted in the Notice of Selection (NOS). This may include, but is not limited to: NCATS, COMIRB, CSU IRB, IACUC, Biosafety,
IBC, Children’s Hospital Research Institute (CHRI), and/or other regulatory groups relevant to the proposal and institution where the research will take place. It is the PI’s responsibility to obtain all regulatory approvals.
Pilot projects that are funded through the CCTSI by the National Center for Advancing Translational Sciences (NCATS) must also be reported to the NIH. PIs will be notified in their Notice of Selection letter if federal approval (called “NCATS Prior-Approval”)
is required or not. CCTSI administration will assist you with collecting the required documents and reporting to NCATS on your behalf. Note: NCATS requires ALL institutional IRB/ICACUC documentation to indicate the name of the CCTSI Pilot Grant awarded
If a project will use CTRC resources, PIs must obtain Scientific Advisory and Review Committee (SARC) approval. CTRC resources include inpatient/outpatient research facilities, clinical research nursing support, nutrition research support, exercise research
laboratory, ancillary funds; and CTRC Core Lab support.
Any clinical trials proposed in Pilot applications are restricted to Phase I or Phase IIA. Phase IIB, Phase III or Phase IV clinical trials will not be supported.
All NIH regulations related to human fetal tissue research and human stem cell and pluripotent stem cell research flow down to CCTSI Pilot Grant Award projects. If funded, projects involving these types of research must undergo review by the institutional scientific ethics committee. Please email Alison Lakin to discuss the institutional review process.
Protecting Intellectual Property and Products
Public disclosure, either in text or verbal form, may result in a lost opportunity to protect and commercialize your invention. All Principal Investigators must connect with the CU Innovations Office (303-724-0221) for a consultation prior to receiving
funds. In the event that a patent does arise from a funded project, it is imperative that CCTSI support is acknowledged (click “Cite Our CTSA Grant” for language).
Award funds are distributed only after CCTSI has received documentation of required institutional and/or federal regulatory approval noted in the Notice of Selection (NOS). The active award period ends April 30, regardless of start date. PIs are strongly
encouraged to complete their projects within the original one-year active award period. No-Cost-Extensions (NCEs) are granted on a very limited basis for extraordinary circumstances and may not be allowed on all programs.
PIs must spend awards on direct costs related to achievement of specific aims outlined in the Pilot Grant project application. PIs must retain sufficient documentation of all expenses to justify any audit requests made of the CCTSI specific to the project.
Unallowable expenses include (but are not limited to): international entities, computers, telecommunications, food, furniture, administrative support, non-project specific office expenses, professional society dues/fees, and research conducted outside
the United States. However, proposals that use data or samples collected at international sites through other means may be considered for funding of the portion of the work conducted locally at CCTSI Affiliated Institutions. While salary support commensurate
with percent effort is allowed for PI and personnel from CCTSI Affiliated Institutions, this is subject to NIH salary cap restrictions.
Project Progress Monitoring
The CCTSI, as a component of its ongoing NIH support, is required to submit a detailed annual progress report that includes all funded pilot projects. In January of each year, PIs will be asked to submit an online Mid-Project Progress Report. This brief
report includes anticipated end-date for research activities, details on publications, patents, and tangibles, and follow-on funding arising from the CCTSI funded project. Prompt cooperation in providing the required information is expected.
The active award period ends on April 30, and the Pilot Grant award is closed out in two parts: project closeout and financial closeout.
The CCTSI funded portion of the project is closed out when the PI submits a brief online Closeout Report. This report includes a summary of the research results, publications, patents, and tangibles, and follow-on funding arising from the CCTSI funded
project. Prompt cooperation in providing the required information is expected.
All financial transactions must be posted within 30 days of the end date of the project. CCTSI will coordinate the primary spending account closeout for each award at the PI and/or Co-PI’s institution, including inactivating speedtypes. The financial
administrator in the PI’s home department may further close out purchase orders, vendors, MSA/GO accounts at CHCO, etc.
Ongoing Reporting Requirements
The CCTSI Evaluation Core will contact PIs and/or Co-PIs annually for three years following the close of the award to collect updates on publications, patents, tangibles, and follow-on funding arising from CCTSI funded projects. Prompt cooperation in
providing the required information is expected.
Citing CCTSI Funding
Please refer to the How to Cite our CCTSI Grant for all publications, patents, or other tangible outcomes
from this project during and after project completion.