Modification of PAR-10-186: NIAID Clinical Trial Implementation Cooperative Agreement (U01)

Notice Number: NOT-AI-11-025

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
E-mail: ar15o@nih.gov