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 #
XII. Summary of Updates to Guidelines Version 1.1 Dated 12/15/2012
(Compared to initial Version 1.0 dated 7/23/2012)
Page 1: Changes to Title Page showing new date & Version of Guidelines document.
Pages 1-13: Multiple Changes to Titles in Table of Contents for these revisions.
Pages 19: Information on Full Accreditation of the NCI Central IRB by AAHRPP and the change to
the independent model.
Page 43: Correction to reference to section of Guidelines on review policy for correlative
science studies embedded in clinical trials as well as requests for use of banked
specimens (i.e., correct reference is to Part 1. Section IV.C.3 of these Guidelines,
especially sub-section 3.1).
Pages 51, 58, 62,
69, 73, and 218: Correction to reference the specific area on the OHRP website related to OHRP policy
regarding “IRB Review of Applications for HHS Support” for applications submitted
under the NCTN Program FOAs (i.e., http://www.hhs.gov/ohrp/policy/aplrev.html).
This new URL is now listed under the appropriate “IRB Review” subsections on these
pages.
Page 67: Clarification that the Lead Academic Participating Site’s governance should clearly
describe how “funding” associated with patient enrollment is distributed at the
institution among various disciplines and clinical departments involved in NCTN trials
at the institution (replaces the previous phrase of “per-case management funding”
which was not accurate).
Page 96: Correction to phone number for NCI/DCTD Senior Program Specialist for the NCTN.
Page 99: Clarification provided regarding eligibility requirements for organizations and
individuals under the various RFAs/FOAs of the NCTN Program.
Page 104: Clarification that budget requests for follow-up capitation and tumor banking
expenses related to legacy studies may be included in the Operations Center budget
with a detailed budget justification under certain circumstances.
Page 108: Clarification that a table listing member Institutions (as described on page 238) should
be submitted in the Resources section of the PHS398 application for the Network
Group Operations Center.
Pages 113-114 Clarification of the “Accrual Input Table” that the Network Group Operations Center
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 Network Group Operations Center
applicants as “Just in Time” information.
Page 117: Clarification that budget requests for data management expenses related to legacy
studies may be included in the SDMC budget with a detailed budget justification in
unusual circumstances.
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