NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications
C. Network Lead Academic Participating Sites - List of Tables with Suggested Formats
Suggested reporting period over the past 5-6 years for all tables requested for the application, unless otherwise indicated, is January 1,
2007 through June 30, 2012.
Lead Academic Participating Site applicants should include key leadership, scientific achievements, and accrual information from
participation in the former/current NCI-sponsored Cooperative Group Clinical Trials Program. Only if the Academic Site applicant did
not participate in the former NCI-sponsored Cooperative Group Program should the applicant provide accrual and other information
from cancer clinical treatment trials supported by an equivalent non-profit, late-phase (primarily phase 3) clinical trials network
organization that conducts oncology treatment trials (not industry, investigator-initiated, or early phase trials).
Accrual tables are accrual of ADULT patients for cancer treatment trials only; if applicant wishes to emphasize significant past ADULT
patient accrual on primary advanced imaging studies under the NCI Cooperative Group Program funded by NCI Division of Cancer
Treatment & Diagnosis (DCTD) or equivalent system for applicants who did not participate in the NCI Cooperative Group Program, that
information can be presented in the text of Research Plan under “Site Accrual Program.” Leadership and scientific achievement from
DCTD-sponsored Cooperative Group primary advanced imaging studies can be included in the appropriate tables with achievements
from treatment trials. Accrual and other information related to cancer control/symptom management and prevention studies should
NOT be included in this application as those studies are funded through a separate grant program by the NCI Division of Cancer
Prevention (DCP).
Table 1. Key Leadership Staffing for Network Group(s) & NCI Steering Committees / NCI Central IRBs As of the Date of
Application Preparation: MM/DD/YYYY
This table should reflect the current positions held by investigators that are at the applicant institution as of the date the table is
prepared for the application (NOT former positions held by institutional investigators or positions held by investigators who are not
currently at the institution). Only key senior leadership positions (i.e., Chair or Vice-Chair) on Group scientific or administrative
committees and standing subcommittees under those main committees should be listed, NOT general members of the committees.
However, general membership on important Group oversight committees (e.g., Data Monitoring Committee, Executive Committee) or
membership on NCI disease-specific Steering Committees (e.g., Breast Cancer Steering Committee) or standing Task Forces of NCI
disease-specific Steering Committees (e.g., Colorectal Task Force of NCI GI Steering Committee, Prostate Task Force of NCI GU Steering
Committee) can be included in table, not just the senior positions on those committees. This table should NOT include information on
whether an investigator is a PI on a study; other information can be provided/addressed by the applicant in the text of its Research
Plan based on what the applicant believes will best address the review criteria for the application.
Network Group* or
NCI Steering Committee or NCI Central IRB
Network Group Activity or
NCI Steering Committee Activity or
NCI Central IRB
Network Group #1* Breast Scientific Committee
Network Group #2* Executive Committee
Network Group #3*
*Refers to former/current NCI-sponsored Cooperative Groups
NCI Steering Committee
NCI Central IRB
ETC.
Data and Safety Monitoring Board
NCI Breast Cancer Steering Committee
NCI Central IRB – Adult CIRB
Academic
Member
Status
Chair
Member
Member
Member
Member
Academic
Member
Name
Academic
Member
Title &
Discipline
Table 2. Important, Primary Scientific Achievements for Trials by Major Cancer Category, Trial Phase, & Trial # from
MM/DD/YYYY to MM/DD/YYYY
Include important, primary scientific achievements that were reported only in the past 5-6 years with contributions by the academic
site member while he/she was at the institution). The primary scientific achievement refers to the Primary Endpoint(s) for the trial
specified in the protocol document. Applicants should briefly explain the importance of the achievement regardless of whether
results were positive or negative as it is the importance of the achievement that is the focus of the table for reviewers, not number of
publications.
Cancer Site
etc.
Trial
Phase
Year
(Publication or
FDA Indication or
Other Impact)
Network Group,
Trial Number &
Brief Title
Manuscript or Abstract
Reference
Important Impact of Primary
Scientific Achievement?
(Brief Description)
Contribution by Academic
Site Member
Page 204 of 241
Length of
Service in
Position for
Activity