This document provides the NINDS guidelines for incremental funding of large multicenter studies and this document should be used as a reference for program and grants management staff to discuss the funding of large multicenter studies. All multicenter clinical trials and complex multicenter clinical research projects with funding exceeding $1 million in any given year will have their funding allocated using the following guidelines. A final yearly budget calculated on a per patient basis, recruitment, enrollment, retention and follow-up goals will be agreed upon between the PI and the Program Director before the notice of grant award is released.
The following guidelines apply:
Activities during the Start-up Phase:
1st Year Start-up funds will be distributed at the time of the grant award (of the grant) for start-up activities; these activities include, but are not limited to:
Remaining of 1st year funds will be awarded once NINDS approves the initiation of study recruitment/enrollment and receipt of acceptable progress reports.
These funds will be awarded proportional to the time left in that award year or once a proportion of clinical sites have IRB approval (this will be negotiated by the NINDS and detailed in the notice of grant award) with the understanding that funding will be spent proportional to the percent of sites on board. The grant budget period may be extended to accommodate this activity and additional funds will be available if recruitment/enrollment is above expected levels, up to the initial 1st year approved funding level.
Study staff who are not required during the start-up phase should not be hired until the study is about ready to begin and training is scheduled (this may include, but not be limited to clinical, lab, and follow-up staff).
Subsequent Years Funding
Subsequent Year Funding will be awarded based on study progress, including whether recruitment goals have been met and the previous years' expected enrollment/retention/follow-up of patients has been achieved. For full funding to be awarded, NINDS expects that overall the study should achieve at least 80% of the targeted enrollment and 90% retention of those participants from the previous year. If enrollment, retention, or follow-up of patients is below this percent, funding will be offset (adjusted accordingly) or the project year can be extended based on the percent of target enrollment, retention or follow-up. The yearly award amount will be commensurate with enrollment, retention and/or follow-up. Additional funding up to the Council recommended amount will be provided during the year based on study progress. Funds may be restricted to ensure that monies are available for patient care and appropriate patient safety and monitoring. Funding decisions will be made based on the quarterly progress report.
Last Modified November 18, 2015