CREATE Devices: Milestones & Regulatory Resources

Prior to funding an application, NINDS program staff will contact the applicant to discuss the proposed milestones and any changes suggested by the NINDS review panel or NINDS program staff.  A final set of NINDS approved milestones will be specified in the Notice of Award. Progress towards achievement of the milestones will be evaluated by NINDS program staff. If justified, future milestones may be revised based on data and information obtained during the previous project period. If, based on the progress report, a funded project does not meet the milestones, funding for the project may be discontinued.  In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless if they have been captured in the milestones), overall progress, NINDS portfolio balance and program priorities, competitive landscape, and availability of funds.

Because device development is an inherently high-risk process, it is anticipated that there will be significant attrition as projects move through the device development process. Applications must propose one or more milestones associated with each Specific Aim and there must be at least one milestone each year (except the last year). Milestones are goals that are quantifiable for measuring success that can be used for go/no-go decision-making for the project, and should have quantitative criteria associated with them.

Milestone Examples and Resources for Regulatory Guidance are available to help guide applicants when they are developing their application.