NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 3: Submission Non-Competing Applications Section II – Research Plan & Budget
II. Non-Competing Continuation Applications Format and Budget Requests
The information included in a non-competing continuation application (also called an annual progress
reports or Type 5 Application) should be provided in formats similar to the ones presented in this Part of
the Guidelines and should follow the requirements of the PHS2590 available at:
http://grants.nih.gov/grants/funding/2590/2590.htm.
Providing the information in a standard format will allow both the key component of the NCTN Program
and the responsible the responsible Lead NCTN Program Director and Co-Program Directors/Project
Scientists to evaluate the progress of the key component more easily and to identify areas that need
attention. The format may be varied somewhat, depending on the key component submitting the
application; however, it should be similar to what is presented here. The instructions on the following
pages cover application formats for all key components of the NCTN Program. The non-competing
continuation application must specify the 12-month period for which data are being reported, and this
same 12-month period should be used for all information presented.
It is anticipated that additional instructions/modification as to what information should be
included in the annual progress report may be given to awardees of all the key components of
the NCTN Program by the Lead NCTN Program Director prior to submission of the first annual
progress report, especially with respect to streamlining the report.
A. Applications for all Key Components of the NCTN Program
1. Research Plan (Annual Progress Report – Type 5 Application)
The Research Plan for each Type 5 application should follow the requirements of the PHS2590.
In all cases, brief and concise descriptions in the research plan of annual progress are
encouraged. Sections 1.1 and 1.2 on accrual and clinical trial performance described below
apply only to the annual progress reports for the Network Group Operations Centers, the
Canadian Collaborating Clinical Trials Network, and the Network Lead Academic Participating
Sites. Section 1.3 on clinical trial development applies only to the annual progress reports for
the Network Group Operations Centers and the Canadian Collaborating Clinical Trials Network.
1.1 Accrual Performance & Accrual by Gender and Ethnicity/Race
Network Group Operations Centers, Network Academic Participating Sites, and the Canadian
Collaborating Clinical Trials Network should provide a summary table that lists the number of
patients accrued during the current funding period (i.e., the three [3] most recently
completed quarters during the funding period plus a projection for the current fourth
quarter) with the exact calendar dates/time-periods used to provide the actual and
projected accrual noted at the top of the table. Accrual for all studies (treatment and
advanced imaging) and per patient biospecimen collection on trials that were open during
the annual project period should be reported summarized by major disease category and
trial phase. A similar report summing accrual across all disease areas should also be
provided. Total accrual provided by the Network Group Operation Center’s or the Canadian
Collaborating Clinical Trials Network for all its member institutions/sites (or by the Network
Lead Academic Participating Site for its sites and affiliate(s) for which it provides complete
management serviced) broken down by sex/gender and ethnicity/race for all accrual across
all NCTN trials should also be presented using the standard Inclusion Enrollment Report
format provided in the PHS2590. This table should be modified to show sex/gender and
ethnicity/race breakdown in accrual for the previous 3 years (if applicable) in addition to the
current funding period summarized by major disease category only. A summary table for
accrual across all diseases should also be provided. Distribution of subjects should NOT be
provided by individual study or trial phase.
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