NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of Competing New Applications Section I - Application Submission Instructions
application that do not reproduce well in black and white may be included in the application and
allowed Appendix material. However, all figures included in the appendix material must be included
in the application, although they may be reduced in size in the application. Images not included in
the application cannot be included in the appendix.
If your application contains a large number of color illustrations or charts and graphs that will not
reproduce well in black and white, you may also submit a CD with a bookmarked PDF file of the entire
application as one of the two copies of the application sent to the NCI Referral Office on the due
date. Such CDs will be accepted only at the time of application submission. The PDF file should be
bookmarked at major subdivisions of the application so that reviewers can navigate through the file
and find individual components easily. The files should be saved as PDF version no higher than 1.4 for
compatibility with NIH programs and software.
Appendix materials must be included with the copies of the application sent to the NCI Referral
Office on the due date as specified above in Part 2 – Section I.C of these Guidelines. Additional
copies of the collated sets of Appendix material may be requested by the Scientific Review Officer
(SRO) from the Division of Extramural for the peer review of the application and the number of
additional copies and timing of submission should be discussed at the time of the pre-application
consultation with NCI Program Staff and the SRO. Appendix material cannot be used to circumvent
page limitations of the research plan.
All the key components of the NCTN Program can provide the following information (and only the
following information) in the appendix material for their respective applications as described below.
Applicants may submit up to 3 of the following types of publications:
� Manuscripts and/or abstracts accepted for publication but not yet published that are
referenced in the Research Plan of the application.
� Published manuscripts and/or abstracts that are referenced in the Research Plan of the
application only when a free, online, publicly available journal link is not available.
� Patents materials directly relevant to the application.
Other Information:
� Paper PHS 398 applications only may include full-sized glossy photographs of material
such as electron micrographs or gels in the Appendix; however, an image of each (may
be reduced in size but readily legible) must also be included within the page limitations
of the Research Plan.
� Any additional appendix material that is allowed for a specific key component of the
NCTN Program will be listed in the corresponding “Appendix Material and Post
Submission Materials” sub-section in Part 2. II of these Guidelines for that key
component.
E. Notification of International Involvement in NCTN Trials
The NCTN key component should alert the NCI/DCTD Senior Program Specialist when the new
competing application involves any international (non-US) component. In such cases, advance
clearance from the U.S. Department of State is required for each non-US component prior to the
award. The information required by U.S. Department of State is listed below (this information should
also include all non-US subcontracts).
� Estimated annual Total Cost dollar award for the non-US component
� Name, organization, city, and country of the International (non-US) Principal or
Collaborating Investigator(s)
� Biosketch and Curriculum Vitae (CV) for both the domestic Principal Investigator and the
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