NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria
Canadian Collaborating Clinical Trials Network
applicant’s member institutions/sites have the potential to help contribute to accrual
of patients to NCTN clinical trials in rare tumors? Does the applicant demonstrate the
ability to meet protocol-specified accrual goals in a timely manner for trials it
conducts?
2.6.4 Additional Review Item B – Operational Management
Operational Structure, Policies, and Procedures: Are the organizational structure and
management policies of the proposed Canadian Collaborating Clinical Trials Network
clear and appropriate, including appropriate sound financial management policies and
procedures for grant administration, subcontracting with collaborating organizations,
purchase service agreements for member institutions/sites, and other related
activities (e.g., laboratory testing needed for specific clinical trials)? Does the
applicant incorporate procedures and tools that enhance coordination and
productivity of operational activities including protocol development?
If the applicant proposes to include international institutions/sites as full members of
the Canadian Collaborating Clinical Trials Network participating in NCTN trials, does
the applicant propose appropriate monitoring plans for these sites as well as
performance assessment monitoring to ensure that the NCTN-supported activities
meet the same requirements regarding conduct of clinical trials expected of full U.S.
member institutions/sites? If the applicant plans to enroll patients on clinical trials
that are led by non-NCTN international clinical trials organizations, does the applicant
propose appropriate policies and procedures to comply with the applicable
regulations and requirements defined in the Terms and Conditions of Award for a
Canadian Collaborating Clinical Trials Network?
Clinical Trial Operations - Development & Conduct: Are the structure and
composition of trial proposal and protocol development teams proposed by the
applicant appropriate? How well does the applicant's proposed trial proposal and
protocol development process mesh with NCI standard tools and services, including
use of Common Data Elements and standard Case Report Form modules? How
appropriate are the proposed Canadian Collaborating Clinical Trials Network policies
and standardized procedures for development and monitoring of trial proposals and
protocols (including its tracking and project management systems) for ensuring that
the applicant would meet NCI-mandated trial activation timelines for operational
efficiency (i.e., Operational Efficiency Working Group or OEWG timelines)?
Does the proposed Canadian Collaborating Clinical Trials Network have appropriate
key standard operating 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 Model
Informed Consent Document for clinical trials that address how it will assure
compliance with NCI, NIH, and HHS policies and all U.S. federal regulations regarding
the protection of human subjects in clinical research as well as how it will address
study monitoring and reporting (e.g., explain how these aspects are covered by the
applicant’s policies on Data and Safety and Monitoring, Data Sharing, Biospecimen
Sharing, and Onsite Auditing)?
Does the applicant demonstrate that it can adhere to regulations regarding trial
registration in the NCI Clinical Trials Reporting Program (CTRP) and in the U.S.
National Library of Medicine (NLM) (www.clinicaltrials.gov) along with results
reporting, as applicable? Does the applicant demonstrate that it can publish results in
Page 180 of 241