NCI National Clinical Trials Network (NCTN) Program Guidelines

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Part 4: Appendices – VII. Accrual Input by Member Institution/Sites for Network Group Operations Center Budget Request for New/Competing Applications XI. List of Member Institution/Participating Sites for Network Group Operations Center and Canadian Collaborating Clinical Trials Network Applications List of Member Institutions/Participating Sites for Network Group Operations Center Applications and Canadian Collaborating Clinical Trials Network Applications that is REQUIRED to be Provided in RESOURCE Section of PHS398 Applications, with Suggested Format Illustrated Below Institution Name NCI Institution Code (if applicable) University of XXX YY000 Main Member Health Corner Unit YY001 XXXX CCOP (or XXXX MB-CCOP) ETC. XX000 Membership Type City Affiliate (Affiliate of University of XXX) CCOP (or MB-CCOP) State (or Province) Country Please sort by all US members first and then international members. Within US or International Category, please sort by Membership Status (i.e., Main Members & their Affiliates, CCOPs and MB-CCOPs, & Others) and then by country, state/province, city, and NCI Institution Code (if applicable). Page 238 of 241
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. Page 239 of 241
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NATIONAL CANCER INSTITUTE NATIONAL
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NCTN Program Guidelines Table of Co
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PART 1: Overview of NCTN Program Se
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PART 1: Overview of the NCTN Progra
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PART 2: Submission of Competing New
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PART 2: Submission of New/Competing
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Page 187 and 188: PART 3: Submission of Non-Competing
Page 189 and 190: TYPE OF STUDY PART 3: Submission No
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Page 195 and 196: PART 4: Appendices Section II - Req
Page 201 and 202: Participating Site Member Category
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Page 237: Part 4: Appendices - VII. Accrual I
Page 241: Part 4: Summary of Updates to Guide
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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