NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget & Research Plan
Network Group SDMCs
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 Network Group SDMC 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 Data and Safety and Monitoring Boards/Plans Updates
The Network Group Operations Centers should have a Data and Safety and Monitoring
Board (Data Monitoring Committee) policy for randomized phase 2 and phase 3 NCTN trials
that complies with the “NCI NCTN Program Data and Safety Monitoring Board Policy” as
provided in Part 4 – Appendices – Section VIII of these Guidelines. In addition, the Network
Group Operations Center must have Data and Safety Monitoring plans for all other Network
Group studies (e.g., phase 1 and phase 2 studies, pilot studies, etc.) that comply with the NIH
policy for data and safety monitoring, posted on the NIH website at:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html, with additional description
at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
These policies/plans should be provided in the research application; however, prior to
funding of an award, all Data and Safety Monitoring Board (Data Monitoring Committee)
policies/plans (and any updates to these policies/plans) will also need to be reviewed and
approved by NCI/DCTD program staff prior to funding of an award to ensure that they are in
compliance with NCI/NIH regulations and the Terms of the Award for the applicable key
component of the NCTN Program.
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