NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
� For publications associated with NCI-sponsored Network Group studies that do not involve
agent(s) supplied under CTEP Collaborative Agreements (except as noted below for press
releases), the Lead NCTN Program Director must receive a copy of the manuscript or
abstract 30 days in advance of publication and a copy of abstracts should be provided 3 days
in advance of publication. Unlike the situation for agent(s) supplied under CTEP
Collaborative Agreements, however, no review or comments will be provided by CTEP
unless specifically requested by the Group. This is simply a confidential notification. Review
timing for publications other than abstracts or manuscripts should be discussed with
appropriate NCI/DCTD staff.
� All press releases issued by the NCI and/or the Network Group on primary study findings
and results require review by NCI, NIH, and DHHS. Pre-review timing for press releases on
study finding and results must be discussed with and approved by the Lead NCTN Program
Director. Network Groups are encouraged to send drafts of press releases on other topics
to NCI for pre-review and/or pre-release notice.
� In addition to the requirements listed above, Network Groups should consider carefully
whether any findings from clinical trials that are pending reporting/publication may have
major impact for public health in the particular disease area. If there is the potential for
major impact for public health, the Network Group must inform the Lead NCTN Program
Director and work closely with NCI to ensure that the information is released to the public in
as timely a manner as possible and in a manner to ensure appropriate communication about
the results, including how they may affect other ongoing trials and the treatment of patients
on those trials.
Post-Publication Reporting & Submission to NIH Manuscript System:
� Network Groups must report publication references in their competitive Type 1 and Type 2
applications as well as non-competing Type 5 applications for major clinical trial results and
important associated studies to demonstrate the scientific accomplishments of their
research strategy. Only references for the manuscripts for key findings should be reported.
Copies of manuscripts cannot be submitted as part of the research plan or as appendix
material.
� The NIH Public Access Policy ensures that the public has access to the published results of
NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts
that arise from NIH funds to the digital archive PubMed Central upon acceptance for
publication. To help advance science and improve human health, the Policy requires that
these papers are accessible to the public on PubMed Central no later than 12 months after
publication. More information about this policy or the submission process is available on the
NIH Public Access Policy website at: http://publicaccess.nih.gov/.
1.1.6 Data Rights
The NCI will have access to all data generated under this Cooperative Agreement and may
periodically review the data. The awardee will retain custody and primary rights to the data
consistent with current DHHS, Public Health Service (PHS), and NIH policies. Pharmaceutical and
biotechnology companies will have access to all data generated under CTEP Collaborative
Agreements; however, the companies may contract directly with the Network Groups for access
to non-Clinical Data Update System (non-CDUS) data and reports.
1.2 Member Site Accrual Program
Network Group Operations Centers are responsible for providing significant accrual to the NCTN
through its institutional and other participating site members and affiliates, CCOP and MB-CCOP
members, and Lead Academic Participating Site members and affiliates that credit the Network Group
with accrual to NCTN trials.
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