NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.4 – Review Criteria
Network Lead Academic Participating Site
advanced imaging trials based on previous accrual history as demonstrated in the
former NCI National Clinical Trials Cooperative Group Program or an equivalent
program? Does the academic center have timely activation of clinical treatment and
advanced imaging trials? Are robust institutional infrastructure and policies in place to
support accrual to NCTN trials? Does the academic center have active programs to
recruit minorities and underserved patient populations to NCTN trials?
Does the accrual to clinical trials by the academic center demonstrate the clinical
focus of clinical practice and research at the institution and of the PD(s)/PI(s)? Do
clinical trials conducted at the academic center appear to be conducted in accordance
with good clinical practice as evidenced by audit results?
Has the academic center developed processes and tools to expedite protocol approval
in their center that would benefit accrual to NCTN trials? Has the institution
demonstrated evidence of targeted information dissemination regarding availability
of Network trials? Does the institution have IT tools or other processes to facilitate
information dissemination? Does the institution use Patient Navigators or other
approaches to encourage accrual of minorities?
Does the academic center provide complete management services and oversight for
any affiliate sites and if so, are the divisions of responsibilities between affiliates and
the academic center clearly and appropriately defined?
Do the investigators at the academic center demonstrate the potential to participate
as members on the NCI CIRB? Does the academic center demonstrate the ability to
have timely review of studies by its local IRB if a phase 1 or phase 2 study is not under
the NCI CIRB?
Does the academic center have appropriate processes in place to provide timely,
accurate, and complete reporting of protocol-specified data, including reporting of
adverse events and submission of required and optional biospecimens, for patients
enrolled on clinical trials? Does the academic center have procedures in place to
verify that it can comply with all applicable Federal/DHHS/NIH/NCI policies and
regulations regarding the use of investigational agents in oncology trials?
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