NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
PART 4: Appendices Section V – Important Definitions, Abbreviations, & NIH/NCI URLs OD Office of the Director at the NCI OEWG Operational Efficiency Working Group OGA Office of Grants Administration OHRP Office for Human Research Protections OPEN Oncology Patient Enrollment Network ORI Office of Research Integrity PD Program Director PHS Public Health Service PI Principal Investigator PIO Protocol and Information Office (in CTEP) PMB Pharmaceutical Management Branch (in CTEP) PRC Protocol Review Committee (in CTEP – also known as NCI/DCTD PRC) RAB Regulatory Affairs Branch (in CTEP) RRP Radiation Research Program (in DCTD) RSS Regulatory Support System (in CTSU) SDMC Statistics and Data Management Center SOP Standard Operating Procedure SPORE Specialized Programs of Research Excellence SRO Scientific Review Officer URL Uniform Resource Locator (internet address of resource) Page 222 of 241
Part 4: Appendices – VI. Sample Table of Contents for PHS398 Applications for the Key Components of the NCTN VI. Sample Table of Contents for PHS 398 Application (Example: Network Group Operations Center) SECTION I Face Page Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, & Human Embryonic Stem Cells Research Grant Table of Contents Detailed Budget for Initial Budget Period & Budget for Entire Proposed Period of Support � Plus Common Budget Outline � Accrual Input by Member Institution/Sites Used to Generate Part of Network Group Ops Center Budget Budget Pertaining to Consortium/Contractual Arrangements Biographical Sketch Program Director(s)/Principal Investigator(s) (Not to exceed four pages each) � Other Biographical Sketches (Not to exceed four pages each – See instructions) � Other Support Information (Submitted only as “Just-in-Time” Information, not with application) Resources � Include Required Tables (See Pages 195 to 201) � List of Member Institutions/Participating Sites of Network Group (See Page 238) � Include Key SOPs � 1 Page Justifications for Restricted Categories of Funding for Legacy Studies (See Page 104) – limited to follow-up for certain categories of legacy trials & sites, bridge funding for tumor banking activities, and special data management for select legacy studies with large resource needs SECTION II Research Plan Checklist Appendix Specific Aims (including Impact Statement) Research Strategy Sections A. Operations Center Overview (up to 12 pages) B. Clinical Trial Development Program (up to 30 pages) C. Member Site Accrual Program (up to 12 pages) D. Operational Management (up to 12 pages) E. Program for Collaborations and Participation in Collective Management (up to 12 pages) Bibliography and References Cited Protection of Human Subjects Inclusion of Woman and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agent Research Multiple Program Director/Principal Investigator (PD(S)/PI(S)) Leadership Plan Consortium/Contractual Arrangements Letters of Support (e.g., Consultants) Resource Sharing Plans Page 223 of 241
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Part 4: Appendices – VI. Sample Table of Contents for PHS398 Applications for the<br />
Key Components of the <strong>NCTN</strong><br />
VI. Sample Table of Contents for PHS 398 Application (Example: <strong>Network</strong> Group Operations Center)<br />
SECTION I<br />
Face Page<br />
Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors,<br />
& Human Embryonic Stem Cells<br />
Research Grant Table of Contents<br />
Detailed Budget for Initial Budget Period & Budget for Entire Proposed Period of Support<br />
� Plus Common Budget Outline<br />
� Accrual Input by Member Institution/Sites Used to Generate Part of <strong>Network</strong> Group Ops Center Budget<br />
Budget Pertaining to Consortium/Contractual Arrangements<br />
Biographical Sketch<br />
<strong>Program</strong> Director(s)/Principal Investigator(s) (Not to exceed four pages each)<br />
� Other Biographical Sketches (Not to exceed four pages each – See instructions)<br />
� Other Support Information (Submitted only as “Just-in-Time” Information, not with application)<br />
Resources<br />
� Include Required Tables (See Pages 195 to 201)<br />
� List of Member Institutions/Participating Sites of <strong>Network</strong> Group (See Page 238)<br />
� Include Key SOPs<br />
� 1 Page Justifications for Restricted Categories of Funding for Legacy Studies (See Page 104) – limited to<br />
follow-up for certain categories of legacy trials & sites, bridge funding for tumor banking activities, and<br />
special data management for select legacy studies with large resource needs<br />
SECTION II<br />
Research Plan<br />
Checklist<br />
Appendix<br />
Specific Aims (including Impact Statement)<br />
Research Strategy Sections<br />
A. Operations Center Overview (up to 12 pages)<br />
B. <strong>Clinical</strong> Trial Development <strong>Program</strong> (up to 30 pages)<br />
C. Member Site Accrual <strong>Program</strong> (up to 12 pages)<br />
D. Operational Management (up to 12 pages)<br />
E. <strong>Program</strong> for Collaborations and Participation in Collective Management (up to 12 pages)<br />
Bibliography and References Cited<br />
Protection of Human Subjects<br />
Inclusion of Woman and Minorities<br />
Targeted/Planned Enrollment Table<br />
Inclusion of Children<br />
Vertebrate Animals<br />
Select Agent Research<br />
Multiple <strong>Program</strong> Director/Principal Investigator (PD(S)/PI(S)) Leadership Plan<br />
Consortium/Contractual Arrangements<br />
Letters of Support (e.g., Consultants)<br />
Resource Sharing Plans<br />
Page 223 of 241
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