Notice of Correction to RFA-HL-13-003 Ancillary Studies in Clinical Trials (R01)

Notice Number: NOT-HL-12-145

Key Dates

Release Date: May 24, 2012

Related Notices
RFA-HL-13-003

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

On December 7, 2011, the NHLBI issued a Funding Opportunity Announcement (FOA): RFA-HL-13-013 Ancillary Studies in Clinical Trials
http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-13-003.html

The following correction to this FOA is being made:

Section IV. Application and Submission Information   

6. Other Submission Requirements and Information

Special Instructions

Current LANGUAGE:
A brief Protocol Summary of the parent trial and the IRB-approved informed consent documents must be included in item 12 of the SF424 of your application.  The draft protocols and draft consent forms for the ancillary study should also be included in item 12 of the SF424. IRB approval is not required at the time of submission for the ancillary study protocol and related documents.  Successful applicants will be required to submit this information at the time of award.  NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary.

NEW LANGUAGE:
A brief Protocol Summary of the parent trial and the IRB-approved informed consent documents must be included in item 12 (Other Attachments) of the ‘Research and Related other Project Information’ found in the Mandatory Document section of your application package.  The draft protocols and draft consent forms for the ancillary study should also be included in item 12 of this section.  IRB approval is not required at the time of submission for the ancillary study protocol and related documents.  Successful applicants will be required to submit this information at the time of award.  NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary.

Inquiries

Inquiries should be directed to:

Suzanne Goldberg, R.N., M.S.N.
Atherothrombosis and Coronary Artery Disease Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8143 (MSC 7956)
Bethesda, MD 20892-7940
Telephone: (301) 435-0532
Fax: 301-480-3667
Email: goldbergsh@mail.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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