FAQS

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

Process for Solicitation and Review of Clinical Studies for NeuroNEXT

Data Coordinating Center (FOA RFA-NS-11-010)

  1. For the DCC, are IND trials expected and will the center oversee collection of site essential documents?
    The network is expected to perform some trials under IND. The CCC will collect data from each site and provide that data to the DCC for analysis. The DCC will analyze overall study data and report its findings to the FDA.

  2. Does the electronic data collection and data management system need to be a 21CFR Part 11 compliant system, in order to be responsive to the NEXT–DCC RFA?
    Yes. If the trial records/signatures are in electronic form (as opposed to paper) and would be used for later submission to the FDA as part of an IND/NDA, they would have to be in compliance with 21 CFR Part 11.