NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
these elements are expected to be designed to optimize the applicant's capability to
develop, activate, and conduct clinical trials in a timely manner. Specifically, address the
following aspects:
Governance & organizational structure of leadership team for the Operations Center.
Define the roles and responsibilities of the PD(s)/PI(s), including responsibilities for human
subjects in clinical studies. If applicable, outline in this sub-section a rationale and the
general benefits of choosing a multiple PD(s)/PI(s) approach. NOTE: Applicants designating
multiple PD(s)/PI(s) must also complete the dedicated Section 12 of PHS 398 Research Plan
"Multiple PD(S)/PI(S) Leadership Plan."
Scope and authority of the applicant's leadership team. Delineate the roles of other key
members of the leadership team in terms of scientific, administrative, and/or technical
responsibilities, as appropriate, such as the Director of Operations position and the
Executive/Advisory Committee. Outline communication plans, processes for making
decisions on scientific directions, and procedures for resolving conflicts. Include succession
plans for key leadership positions and describe the relationship/rules for institutional
membership in the Network Group as well as financial management policies.
Operational efficiency. Describe plans to optimize the operational efficiency in both study
development and clinical trial activation, including providing appropriate training programs
for protocol chairs, institutional site PD(s)/PI(s), and clinical research associates (CRAs).
Indicate how the proposed Center will take advantage of the available, NCI-supported
standard tools and services for the conduct of clinical trials (e.g., Clinical Data Management
System, Oncology Patient Enrollment System, and Regulatory Support System for the NCTN).
Address how the proposed Center will assure the compliance with NCI/NIH and other
Federal regulations regarding study monitoring and clinical research (e.g., explain how these
aspects are covered by the applicants’ policies on Data and Safety Monitoring, Data Sharing,
Biospecimen Sharing, and Onsite Auditing).
The applicant should also present a plan and demonstrate its ability to adhere to regulations
regarding trial registration in the NCI Clinical Trials Reporting Program and in the U.S.
National Library of Medicine (NLM) (www.clinicaltrials.gov) along with results reporting, as
applicable. The applicant should also describe its plan to ensure that results from clinical
trials will be published in peer-reviewed manuscripts in a timely manner consistent with
NCTN Program requirements and demonstrate its potential to do so. The applicant should
also describe its plans for and demonstrate its capability to make data and biospecimens
from clinical trials accessible to the public for further research or explain why sharing is not
possible.
The applicant’s key standard operating procedures for the conduct of clinical trials related to
the following should be provided in the Resource section of the application:
� Data & Safety Monitoring Board Policy for Phase 3 Trials & Randomized Phase 2 Trials
� Data and Safety Monitoring Plan for Phase 1 and Phase 2 Trials
� Conflict of Interest Policies
� Onsite Auditing Policy and Procedures
� Constitution & By-laws for Institution/Site Membership and Individual
Participant/Investigator Membership (including Scientific and Administrative
Committee Membership)
� Standard Template for the Informed Consent Document
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