NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.1 – Review Criteria
Network Group Operations Center
procedures related to a Data and Safety Monitoring Board Policy for Phase 3 trials and
randomized Phase 2 trials, Data and Safety Monitoring Plans for phase 1 and Phase 2
trials, Conflict of Interest Policies, and a standard template for the Informed Consent
Document for clinical trials that are in compliance with NCI/CTEP, NIH, and federal
regulations?
Compliance/Quality Assurance/Auditing: How well do the applicant's proposed policies
and procedures for clinical trial conduct comply with good clinical practice, including all
Federal/HHS/NIH/NCI requirements related to clinical trial research with human
subjects, as well as with NCI/DCTD requirements related to NCI/DCTD Intellectual
Property policy, NCI/DCTD Cooperative Research and Development Agreements for
clinical trials conducted under an NCI Investigational New Drug (IND) or Device
Exemption (IDE) or other NCI binding collaborative agreement? How appropriate are the
applicant's plans to ensure the quality assurance of clinical trial data and collection of
biospecimens? How appropriate are the applicant's proposed policies and procedures in
meeting the onsite audit requirements of the NCI Clinical Trials Monitoring Branch
Guidelines (CTMB) for its member institutions/sites? How appropriate are the
applicant's plans to appropriately address issues with member institutions/sites noted
at the time of audit, including non-compliance, data quality, data reporting
requirement, and timeliness of audits and re-audits? Does the applicant propose a
quality assurance program with its associated Statistics and Data Management Center
that is adequately proactive in terms of ensuring ongoing quality control of data during
trial conduct?
2.1.6 Scored Review Criteria – Criterion D. Program for Collaboration & Participation in
Collective Management
(Note: The entire Criterion D will receive one individual score; the subcategories and
aspects listed will be assessed but not scored separately).
Collaborations with NCTN Network Groups, NCTN Programs/Initiatives, and other NCIsponsored
Programs/Investigators: Does the applicant have a track record for
collaborations with other trial organizations and other NCI-sponsored programs and
investigators (e.g., SPORE awardees, NCI Cancer Centers, R01/P01 investigators) on
clinical trials and translational science studies that demonstrates its potential for
collaboration within the NCTN Program? Has the applicant demonstrated that it has the
capacity to conduct clinical trials that come from investigators outside its own
organization?
Collective Management Activities: Does the applicant have a track record that
demonstrates that the members of it scientific leadership teams (i.e., scientific research
committee members) actively participate in or can actively contribute to NCI-supported
clinical trial activities (e.g., disease-specific Scientific Steering Committees and related
task forces or working groups, Clinical Trials Planning Committees for meetings
supported by the NCI disease-specific Steering Committees, membership on the NCI
Central IRB, participation in other NCI programs and initiatives related to clinical
research)? Do Group members participate as members of the NCI Central IRBs? Do
Group members participate in the onsite auditing program for the Network Group
Operations Center?
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