NCI National Clinical Trials Network (NCTN) Program Guidelines

Part 4: Summary of Updates to Guidelines Version 1.1 (12/15/2012) Revisions Listed by Page #
Page 128: Clarification is provided on rationale for inclusion of any affiliate in a Lead Academic
Participating Site application (i.e., for administrative ease only) as well as clarification
of the description of the affiliate relationship with the academic center which permits
an affiliate to be included in the application. This section also clarifies that affiliates
do not have to be included in the application and that the activities of the affiliates
are not part of the review criteria for the application – affiliate accrual is provided to
justify the budget request only; however, if an affiliate is included in an application for
a Lead Academic Participating Site (academic center), then it cannot be an affiliate of
another organization for the purposes of its participation in the NCTN program
treatment and advanced imaging trials.
Page 130: Correction to statement that for Lead Academic Participating Site applicants, total
costs for scientific leadership and coordination activities at the academic center
should be based on a percentage of total costs related to “intervention per case
management” funding and “non-intervention per case management” funding.
Page 133: Includes statement specifying that the Accrual Input Table for Lead Academic
Participating Site applications should be put in the Resources section of the PHS398
application and provides a reference to an example of the table on page 237.
Page 135: Clarification that a Letter of Support should be included in the Lead Academic
Participating Site Applicant from each affiliate included in the application.
Page 143 Information is provided on additional information that needs to be provided on legacy
studies that the Network Radiotherapy and Imaging Core Services Center applicants
wish to transition to the new program in order to continue to provide services for
those studies.
Page 150 Clarification of the “Accrual Input Table” that the Canadian Collaborating Clinical Trials
Network applicants have to submit as “Just in Time” information. This table is
described on page 236. Also, information is provided on additional information that
needs to be provided on accrual and legacy studies for the Canadian Collaborating
Clinical Trials Network applicants as “Just in Time” information.
Pages 195 to 209: Corrections and Clarifications to All Tables on these pages highlighted in RED Text.
Pages 211 to 215: Corrections and Clarifications to All Tables on these pages highlighted in RED Text.
Page 223: Clarification and Addition to Sample Table of Contents for PHS398 Application for a
Network Group Operations Center Application Highlighted in RED Text.
Page 233: Clarification that Common Budget Outlined is to be submitted with the Network
Group Operations Center Application only.
Pages 236: Clarification that the Table of Accrual Input by Individual Member Sites for the
Network Group Operations Center Application or Canadian Collaborating Clinical Trials
Network Application is to be submitted only as “Just-in-Time” information. Only a
simple list of the Member Sites of the Network Group should be submitted in the
application (in the RESOURCES section of the PHS398) per the description provided on
page 238.
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