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
� All applications, regardless of the amount of direct costs requested for any one year,
should address a Data Sharing Plan. An example of a Data Sharing Plan for Network
Group Operations Centers and associated Network Group Statistics and Data
Management Centers (or Canadian Collaborating Clinical Trials Network) for the NCTN
Program is provided in Part 4 – Appendices – Section VII in these Guidelines.
The Data Sharing Plan and other resource plans (or rationale for not providing sharing
certain resources) should be provided in the research application; however, prior to funding
of an award, all resource sharing plans/policies will also need to be reviewed and approved
by NCI/DCTD program staff prior to funding any award in order to ensure that the
plans/policies are in compliance with NCI/NIH regulations and the Terms of the Award for
the applicable key component of the NCTN Program.
3. Appendix Material & Post Submission Materials
Information on the Appendix material that should be provided in Canadian Collaborating Clinical
Trials Network application, along with information on the timing of submission of this material
and the format in which it should be provided is described in Part 2 – Section I.D. of these
Guidelines as well as in Part 2 – Section II.B.3 for the operations center component of the
application and Part 2 – Section II.C.3 for the statistical component of the application.
Information on post submission materials that may be provided for the Network Group
Operations Center application is described in Part 2 – Section I.F of these Guidelines.
4. Just-in-Time Information
The following material must be submitted prior to the award of the Cooperative Agreement for
the Canadian Collaborating Clinical Trials Network.
4.1 Other Support for Key Personnel
NCI program staff will contact all applicants to be funded to request “Other Support” for Key
Personnel, including consortium/contract personnel. “Other Support” includes all financial
resources, whether federal, non-federal, commercial or institutional, available in direct
support of an individual's research endeavors, including but not limited to research grants,
Cooperative Agreements, contracts, and/or institutional awards. Training awards, prizes, or
gifts are not included. Percent effort should be specified as well as any support that is
pending. Information on other support assists the awarding NCI staff in the identification
and resolution of potential overlap of support. Overlap, whether scientific, budgetary, or
commitment of an individual's effort greater than 100 percent, is not permitted. The goals
in identifying and eliminating such overlap are to ensure that: (1) sufficient and appropriate
levels of effort are committed to the project, (2) there is no duplication of funding for
scientific aims, specific budgetary items, or an individual's level of effort, and (3) only funds
necessary to the conduct of the approved project are included in the award.
4.2 Training on Human Subjects Protection for Key Personnel
As part of Just-In-Time information, the Canadian Collaborating Clinical Trials Network
should also submit a roster of Key Personnel and indicate the type of training program on
human subjects protection completed by each person listed. The NIH policy on Human
Subjects Protection is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-
00-039.html.
4.3 Onsite Auditing Activities
The NCI-CTMB Guidelines for Monitoring of Clinical Trials for Cooperative Groups, CCOP
Research Bases, and the Cancer Trials Support Unit (CTSU) require all Participating Sites to
be audited at least once every 36 months. In order for the NCI to review the Canadian
Collaborating Clinical Trials Network’s compliance with this requirement, the Canadian
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