NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Canadian Collaborating Clinical Trials Network
The applicant should also describe the facilities and equipment available as well as the
information technology (IT) support for central storage, security, analysis and retrieval of
clinical data. The applicant should describe how it complies with guidelines for good clinical
practice and with federal/DHHS/NIH/NCI regulations for clinical research involving human
subjects as well as with NCI/NIH administrative requirements for conduct of clinical trials
with respect to NCI/DCTD's IP Option and NCI/DCTD's collaborative binding agreements for
NCI/DCTD IND studies.
2.5 Sub-section E. Program for Collaborations and Participation in Collective Management (up
to 6 pages)
This functional component should consist of a well-defined plan for potential collaborations
by the applicant with U.S. Network Groups and NCI-sponsored investigators and programs as
well as how the applicant plans to participate in the collective management of the NCTN.
The applicant should address how it can contribute to the collective management of the
NCTN Program through examples of participation in the NCI Scientific Steering Committees
(SSC) and associated Task Forces and Working Groups, and Planning Committees for SSC
Clinical Trials Planning Meetings, or examples of similar activities in other clinical trial
network as indications of its potential to participate in the collective management of the
NCTN. The applicant should also discuss its ability to complete development of study
proposals and conduct future trials that may originate outside the NCTN Program if they are
approved by the NCI disease-specific SSCs.
2.6 Protection of Human Subjects
Applicants should consult the PHS 398/SF424 regarding general instructions on what types
of information should be included in the application regarding human subjects research,
including the protection of human subjects. Information on the targeted/planned
enrollment table for minorities and members of both genders (as well as children, if
applicable), should be based on accrual summarized across all diseases for the planned
project period in the competing new application (Type 1), not on a study or diseasespecific
basis.
The Canadian Collaborating Clinical Trials Network application must address the inclusion of
women and minorities and inclusion of children in its clinical research as required per
NIH/NCI Policy. Information on the policies for inclusion of women and minorities is
available at:
http://grants.nih.gov/grants/funding/women_min/women_min.htm
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
Information on the policies for inclusion of children is available at:
http://grants.nih.gov/grants/funding/children/children.htm
http://www.nih.gov/grants/guide/notice-files/not98-024.html
2.7 Resource Sharing Plans
Applicants are required to comply with the instructions for the Resource Sharing Plans (Data
Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as
provided in the PHS 398 Application Guide with the following modifications:
� Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms if
applicable, and Genome Wide Association Studies (GWAS) are expected in this
application.
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