NCI National Clinical Trials Network (NCTN) Program Guidelines

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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. Page 240 of 241
Part 4: Summary of Updates to Guidelines Version 1.1 (12/15/2012) Revisions Listed by Page # Page 237: Clarification of the information to be provided in the Table of Accrual Input that needs to be submitted WITH the Lead Academic Participating Site application in the RESOURCES section of the PHS398. Page 238: Suggested format List of Member Institutions/Participating Sites for Network Group Operations Center Applicants or Canadian Collaborating Clinical Trials Network Applicants that needs to be submitted WITH the application in the RESOURCES section of the PHS398. Page 241 of 241
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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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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 223 and 224: Part 4: Appendices - VI. Sample Tab
Page 225 and 226: Part 4: Appendices - VII. Model for
Page 227 and 228: Part 4: Appendices - VII. NCTN Prog
Page 233 and 234: Part 4: Appendices - IX. Common Bud
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Page 237 and 238: Part 4: Appendices - VII. Accrual I
Page 239: Part 4: Summary of Updates to Guide
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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