Selection notices are sent by February following the application and review cycle, and Principal Investigators have through June to complete all Pre-Award Pilot Program and Regulatory requirements. Awards can not be issued until documentation of all required approvals is received by the CCTSI Pilot Program Office.
Pilot Program Requirements
- PIs must consult with their Technology Transfer Office (TTO) regarding the possibility that intellectual property (patents) may result from a funded CCTSI pilot project. In the event that a patent does arise from a funded project, it is imperative that CCTSI support is acknowledged.
- CU-Denver PIs are not required to obtain approval from the Office of Grants and Contracts prior to application or award. PIs from affiliate organizations may be required to complete internal review processes at their organization prior to application (notably CSU) or award (notably CU-Boulder).
- PIs must obtain research approval from appropriate review bodies, such as COMIRB, IACUC, IBC, Children’s Hospital Research Institute, or any other regulatory group relevant to their project.
- 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.
- Applications selected for award that include Human Subjects Research may require review and approval of full Human Subjects Research documentation prior to start of award by the CCTSI funding agency, National Center for Advancing Translational Sciences (NCATS). At time of selection for award, the CCTSI will request information regarding your Human Subjects Research to ascertain specific required documentation for your project to submit for NCATS review.
- HSR Documents may include exempt certification, PI biosketch, complete clinical research protocol, informed consent and assent forms, information on portion of any parent protocol supporting pilot or KL2 funding with explanation of exactly what aspects of that parent protocol are related to the pilot or KL2 project, IND or IDE documentation, an NIH-style “Protection of Human Subjects” section, Inclusion Plan for Women, Children and Minorities, Targeted Enrollment Table or Inclusion Data Record, Data and Safety Monitoring Plan, Education Certification for Protection of Human Subjects, and IRB approval of the clinical study (may be under review concurrently with IRB and NCATS).
- PIs must report monthly during the Pre-Award period to the CCTSI Pilot Program Office regarding progress toward completion of all Pilot Program and Regulatory requirements.
Notice of Award
- Once all required Pre-Award activities are complete, the CCTSI Pilot Program Office will issue funding accounts to the PI in the official Notice of Award.
PIs will have 12-months from Notice of Award start date to complete their projects. No-Cost-Extensions are granted on a very limited basis for extraordinary circumstances, and may not be allowed on all programs. PIs are strongly encouraged to complete their projects within the original one year active award period.
- PIs must spend awards on direct costs related to achievement of specific aims outlined in the pilot project application. Unallowable expenses include (but are not limited to): indirect costs (F&A), international entities, computers, telecommunications, food, furniture, administrative support, non-project specific office expenses, and professional society dues/fees.
- PIs must retain sufficient documentation of all expenses to justify any audit requests made of the CCTSI specific to the project.
Project Progress Monitoring
- PIs must respond to requests for interim progress reporting during the active phase of a project. This reporting is minimal and aimed at progress (% completion) relevant to specific aims.
- All financial transactions must be posted within 30 days of the end date of the project.
- PIs must submit a final summary of the project’s impact within 30 days of request from the CCTSI. This web-based report will collect detailed information about the project.
- Upon submission of final summary and posting of final financial transactions, the CCTSI Pilot Program Office will complete audit and closeout procedures for the project.
PIs must complete tracking & evaluation requirements for 3 years after award.
Ongoing Reporting Requirements
- Please refer to the How to Site our CCTSI Grant for all publications, patents, or other tangible outcomes from this project during and after project completion.
- 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 for brief information on publications and follow-on funding resulting from pilot projects. Prompt cooperation in providing the required information is expected.