FDA Guidance Core Utilization Pilot Grants
Prior to beginning application, review the RFA.
- Support can be any amount up to a maximum of $10,000 for primary use in the FDA Guidance Core and other eligible cores to support the work in the FDA Guidance Core as appropriate.
The Clinical and Translational Science Collaborative (CTSC) of Case Western Reserve University FDA Guidance Core Utilization pilot program supports investigator use of the FDA Guidance Core, a comprehensive and standardized resource for investigators who are conducting new drug/new device research with the Food and Drug Administration. Support through the FDA Guidance Core is tailored to the investigators specific needs and can include regulatory document development, risk base monitoring, data management, and long term quality control for the lifecycle of the study.
Funds for the FDA Guidance Core Utilization Grant are directly provided to Investigators by the CTSC partner institutions.
- Primarily, funds must be spent in the FDA Guidance Core and secondarily can be spent in additional eligible Core facilities as needed to support the efforts of the FDA Guidance Core. Budget requests for anything other than core use are not allowed and will be denied.
Principal Investigator must have a primary appointment at Case Western Reserve University, Cleveland Clinic, MetroHealth Medical Center, University Hospitals Cleveland Medical Center and/or The Louis Stokes Cleveland VA Medical Center and must be eligible to submit an application to a larger source of federal or non-federal support.
Applications should be submitted through Webgrants at http://webgrants.case.edu/
The CTSC Core Utilization Pilot Grant is a rolling submission format. Applications are accepted year-round and submissions reviewed monthly.
For questions contact: