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NINDS Neuroscience Funding Announcements



NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials (U01)

Funding Contact(s): Wendy Galpern, MD., Ph.D.
Funding Categories: Clinical Research

Detailed Description:

Highlights of this funding opportunity:
http://grants.nih.gov/grants/guide/pa-files/PAR-13-278.html
NINDS Office of Clinical Research

  • Milestone-driven Cooperative Agreement (U01) grant mechanism (on PHS 398 application forms)
  • September 5, 2013 for the first receipt date; standard U01 dates thereafter
  • Prospective, multi-site, randomized, controlled Phase III clinical trials (or adaptive trials designed with a seamless phase II/III transition)
  • 12 page research strategy, including tables, graphs, figures, diagrams, and charts
  • Separate, but coordinated, applications for the Clinical Coordinating Center (CCC) and the Data Coordinating Center (DCC) are to be submitted for the trial (12 pages each)
  • Application must include the status of regulatory approvals as necessary to conduct the proposed research (e.g., open IND/IDE, or report on pre-IND/IDE meetings and IND/IDE status, or exemption letter from FDA if applicable, and/or status of RAC approval, etc)
  • This funding announcement expects that investigators will use the NINDS Common Data Elements resource (see: http://commondataelements.ninds.nih.gov/) when constructing data element forms
    • The application must include the status of regulatory approvals as necessary to conduct the proposed research (e.g., open IND/IDE, or report on pre-IND/IDE meetings and IND/IDE status, or exemption letter from FDA if applicable, and/or status of RAC approval, etc)
  • This funding announcement expects that investigators will use the NINDS Common Data Elements resource (see: http://www.nindscommondataelements.org/) when constructing data element forms


  • Appendices required (numbered in the order below):
    1. Study Protocol (The final version of the study protocol must be formatted using the NINDS protocol template: (http://www.ninds.nih.gov/research/clinical_research/toolkit/protocoltemplate.htm)
      1. The Manual of Study Procedures (MOP) is not required under this program announcement and should not be included in the application
    2. Recruitment feasibility (table with actual number of patients with disease seen within last 12 months by site, number of those patients who fit all entry criteria by site, proportion of patients with this disease who in the past enrolled into comparable trials: see http://www.ninds.nih.gov/research/clinical_research/application_process/enrollment.htm); and recruitment plan (written plan on how recruitment will occur and what measures are planned to gain the participation of physicians and patients)
    3. IRB approval at the clinical coordinating center strongly suggested at the time of submission, required at time of funding
    4. Other (only as necessary and acceptable under the NIH appendix policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html

NINDS Office of Clinical Research



Grant Mechanism: U01
NIH Guide: PAR-13-278
Release Date: 2013-07-22
Expiration Date: 2016-09-08