Release Date: January 6, 2011
National Institute of Allergy and Infectious Diseases (NIAID)
The purpose of this Notice is to announce a substantive
change to requirements articulated in PAR-10-186:
NIAID Clinical Trial Implementation Cooperative Agreement (U01) and to provide
a clarification for PAR-10-186:
NIAID Clinical Trial Implementation Cooperative Agreement (U01).
In Part II-Full Text of Announcement, Section I. Funding Opportunity Description, 1. Research Objectives, under "Scope, paragraph 6, line 3”:
Delete "include a randomized design" from the sentence that reads: "The trial must be hypothesis- driven, include a randomized design, and have clear primary and secondary endpoints."
Randomization is only required for those trials for which it
is an appropriate element of trial design.
In Section IV. Application and Submission Information, 6. "Other Submission Requirements" section:
Add the following instructions:
The order of assembly of the application should be as follows:
Specific Aims 1 page
Research Strategy 12 pages
HS Section no page limit, place after Research Plan
Clinical Protocol Synopsis 3 pages, place after HS section
Data and Safety Monitoring Plan no page limit, place after Clinical Protocol Synopsis
Milestone Plan 3 pages, place after Data and Safety Monitoring Plan Complete Clinical Protocol no page limit, place after DSMP
All other aspects of PAR-10-186 remain unchanged.
Please direct all inquiries to:
Anna Ramsey-Ewing, Ph.D.
Associate Director for Extramural Science Policy
Office of the Director
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, MSC 7610
Bethesda, MD 20892-7610
Phone: (301) 435-8536
FAX: (301) 402-0369
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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