Notice Number: NOT-CA-10-019

Key Dates
Release Date: March 5, 2010

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

Purpose

The purpose of this Notice is to clarify the location (within each grant application) of clinical protocols that must be included in all applications submitted in response to PAR-08-147, “Quick Trials for Imaging and Image-Guided Interventions: Exploratory Grants (R21).”

All applicants submitting applications in response to PAR-08-147 must include their clinical protocols in Item 16 (Appendix) of the PHS 398 Research Plan component (https://grants.nih.gov/grants/funding/phs398/phs398.html).

The SF424 (R&R) Application guide (https://grants.nih.gov/grants/funding/424/index.htm) (page I-117) specifically states that “Surveys, questionnaires, and other data collection instruments; clinical protocols and informed consent documents may be submitted in the Appendix as necessary.”  In addition, any information pertaining to clinical protocols that can be used as part of the initial peer review must be included in the Research Strategy (Item #3) of the PHS 398 Research Plan component. 

Because clinical protocols will be evaluated as a part of the merit assessments of the applications submitted under this funding opportunity announcement, the clinical protocol(s) must be included under Item 16 (Appendix) in the PHS 398 Research Plan component (and NOT in the Human Subjects section), and the included clinical protocol(s) should be cross-referenced in the Human Subjects section.

Note: For each clinical trial protocol included in an Appendix, please specify if it is: (1) based on an active, ongoing clinical trial that has been (or will be) amended to include the research study proposed in the R21 application; or (2) a newly designed clinical protocol that is currently undergoing Institutional Review Board (IRB) review.

All other aspects of the PAR-08-147 remain unchanged.

Inquiries

For Imaging Trials:

Barbara A. Galen, MSN, CRNP, CNMT
Clinical Trials Branch
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6050, MSC 7412
Bethesda, MD 20892-7412
Telephone: 301-594-5225
Fax: 301-480-3507
Email: bgalen@mail.nih.gov

For Image-Guided Intervention trials:
Pushpa Tandon, Ph.D.
Image-Guided Intervention Branch
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 3005, MSC 7412
Bethesda, MD 20852-7412
Telephone: 301-451-2299
Fax: 301-480-3507
E-mail: tandonp@mail.nih.gov

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	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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