FDA Guidance Core Utilization Pilot Grants

Prior to beginning application, review the RFA.

If this is your first time using WebGrants, you will need to register online at http://webgrants.case.edu. Once you have registered, you will receive an email with your user name and password. The registration process can take up to 24 hours, so applicants are strongly advised to register for an account as soon as possible. Last minute registrations are NOT guaranteed to be approved prior to the deadline. Extensions of the deadline will NOT be given for late registrants.

Available Funds

  • 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.

Eligibility

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/

Deadline

The CTSC Core Utilization Pilot Grant is a rolling submission format. Applications are accepted year-round and submissions reviewed monthly.

For questions contact:

CTSC Pilot Program Office:
CTSC-Pilot-Coordinator@case.edu | CTSC-Research-Concierge@case.edu
216 368-0840