Correction for RFA HL-10-024, Ancillary Studies in Clinical Trials (R01)

Notice Number: NOT-HL-11-108

Key Dates
Release Date:  July 20, 2010

Issued by
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)

Purpose
The purpose of this Notice is to correct and thereby to provide additional information for RFA HL-10-024, Ancillary Studies in Clinical Trials (R01) http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-10-024.html.

Correction: In Section IV.6, PHS398 Research Plan Component Sections, NHLBI inadvertently omitted a key requirement for submission. Prospective applicants are asked to comply with the instructions described in the following paragraph:

The complete clinical protocol of the parent trial and the IRB-approved informed consent documents must be included as Appendix I. 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.

All other aspects of the FOA remain unchanged.

For information about the FOA Ancillary Studies in Clinical Trials, please contact:

Abby Ershow, Ph.D.
Prevention and Population Sciences Program
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
Rockledge 2, Room 8160
6701 Rockledge Drive
Bethesda, MD 20892-8902
Telephone: (301) 435-0550
Email: ershowa@nhlbi.nih.gov

 


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