FAQS

How do I access the form required to submit a proposal to NeuroNEXT?

Process for Solicitation and Review of Clinical Studies for NeuroNEXT

Clinical Coordinating Center (FOA RFA-NS-11-009)

  1. Will tissues and DNAs be banked? If yes, will they need storage on site or will there be "cores" for their analysis at different locations?
    The Clinical Coordinating Center should have the capability to receive, process, track and store samples during the course of a Phase 2 study (i.e., moderate size/duration trial). However, costs for biomarkers and longer-term storage will be included in the actual project funding as needed.

  2. What was the rationale for having two coordinating centers?
    The CCC will coordinate clinical implementation, the DCC statistical and data management operations. Separating the two centers will allow for greater independence between data collection and data operations and monitoring. Soliciting both functions independently will also allow for the opportunity to select the best expertise in each of the two separate fields.

  3. Ad-hoc sites appear not to be interacting with the network CCC; is their contractual/regulatory relationship with the PI only?
    Ad-hoc sites will also be directly interacting with the CCC. The project PI will enter into a contractual relationship with the CCC, and the CCC will distribute per-patient fees to network and ad-hoc sites.