Notice Number: NOT-CA-08-019

Key Dates
Release Date: May 7, 2008

Issued by
National Cancer Institute (NCI) (http://www.cancer.gov/)

Purpose

The National Cancer Institute (NCI) supports an extensive portfolio of clinical trials and clinical trials-related research, including traditional grant-, cooperative agreement-, and contract-supported research projects. The NCI must ensure that funded research projects involving human subjects are compliant with Federal regulations, including procedures to protect the safety of all participants and ensure the validity and integrity of the data and results. These aspects are subject to the new NCI Policy for Clinical Trials Research.

Under this policy, all NCI awardees conducting studies involving human subjects must comply with the NCI Clinical Trials Terms of Award that will be incorporated in their Notices of Award (for grants, cooperative agreements, and contracts). NCI’s Clinical Trials Terms of Award delineate awardee responsibilities including submission of the required documentation to NCI for all NCI-supported clinical trials. They define specific timelines for approvals related to the initiation of a trial and timelines for reporting events related to its progress. It is the responsibility of the awardee to submit required documentation to the appropriate NCI program staff member according to these timelines. This NCI policy and the associated guidelines are in addition to and not in lieu of other NIH policies.  All clinical research supported by NCI must comply with Federal, State, and local regulations. All clinical research supported by NCI that is conducted outside the United States (U.S.) must also comply with the regulations of the host country as well as U.S. federal regulations. In addition, all NCI awardees must register their clinical trials with ClinicalTrials.gov to be in compliance with the 2007 FDA Amendment Act (FDAAA) .

Links:

• This new NCI Policy for Clinical Trials Research is available to the NCI prospective applicants, awardees, and general community at http://deainfo.nci.nih.gov/grantspolicies/ClinicalTrials/Clinical%20Trials%20Policy.pdf).
  
  
• For associated Clinical Terms of Award go to http://deainfo.nci.nih.gov/grantspolicies/ClinicalTrials/Clinical%20Trial%20Terms%20of%20Award.pdf).
  
  
• A Checklist for determining adherence to the NCI Clinical Terms of Award is available at http://deainfo.nci.nih.gov/grantspolicies/ClinicalTrials/NCI%20Clinical%20Terms%20of%20Award%20Checklist.pdf).

Inquiries

For additional information, please contact:

Clinical Trials Reporting Office
National Cancer Institute
2115 East Jefferson St., Mail Stop 8505
Rockville, MD 20852
Fax: 301-480-6641
Email: ncictrp@mail.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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