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 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Appeals Process Center, the Director will direct NCI/DCTD to consider the proposal under the appropriate evaluation or review procedures for the NCTN Program as described in Part 1 – Section IV.C.3.1. of these Guidelines. Page 92 of 241
PART 1: Overview of NCTN Program Section V – Other Administrative Considerations V. Other NCI Administrative Considerations A. Program Staff Administration of the NCTN Program Within NCI/DCTD, major scientific policy and programmatic decisions concerning the NCI National Clinical Trials Network (NCTN) Program are made only after appropriate consultation with and involvement by the responsible Lead NCTN Program Director, the Co-Program Directors of the NCTN Program, the Project Scientists, NCI/DCTD Branch Chiefs and Program Chiefs that are involved in the Program, and the Associate Director, CTEP, DCTD, as necessary and appropriate. Routine programmatic administration is the responsibility of the responsible Lead NCTN Program Director, who assures uniformity of implementation across the various key components in conjunction with the Co-Program Directors of the NCTN Program and the Project Scientists. The Lead NCTN Program Director or his/her designee has responsibility for addressing and approving noncompetitive award (Type 5) budget requests, any supplemental budget requests, and new/competitive award (Type 1) budgets, as well as future Type 2 applications. The responsible Lead NCTN Program Director will administer these tasks in conjunction with the Grants Management Specialist in the Office of Grants Administration (OGA) and will be assisted by the Co-Program Directors of the NCTN Program and the Project Scientists for the key components of the NCTN Program as well as the NCI/DCTD Senior Program Specialist for the Program. B. Senior Program Specialist for the NCTN Program The NCI/DCTD Senior Program Specialist for the NCTN Program works closely with the responsible Lead NCTN Program Director in reviewing administrative materials supporting Group requests, performing budget analyses, and facilitating the completion of action items involving coordination between NCI/DCTD, the NCI Office of Grants Administration (OGA), and the awardees under the Program. The NCI/DCTD Senior Program Specialist exchanges information with the Network Group Directors of Operations for the key components of the NCTN Program and OGA staff on administrative changes and priorities. C. NCI Office of Grants Administration (OGA) The Grants Management Specialist for the NCI Office of Grants Administration (OGA) is responsible for the fiscal and administrative aspects of each application and award. The Grants Management Specialist for OGA works closely with the responsible Lead NCTN Program Director and NCI/DCTD Senior Program Specialist to assure that appropriate science is funded in accordance with applicable laws, regulations, policies, and peer review recommendations to the extent that the budget allows and NCI priorities dictate. D. Miscellaneous Budgetary Considerations 1. Carryover Requests Carry-over requests will be entertained in situations where circumstances prevented funding from being spent during the budget period for which it was provided and where funding is not replicated in the current budget year for an ongoing expense. 2. Requests for Non-competing Supplemental Funding Informal discussions about the possibility of receiving non-competing supplemental funding for special needs and/or additional funding to cover data collection and management and biospecimen collection on a per case basis may be initiated by the awardee for the key component of the NCTN Program. However, formal requests must be made for funding to be received and must always be countersigned by the business official responsible for the Cooperative Agreement/grant and the Principal Investigator(s). Electronic facsimile signatures on documents transmitted via email are acceptable. Most requests, however, will require the use of a Form PHS 398/SF424 or PHS 2590 to capture the details of the requested budget. The original should be sent to the responsible Lead NCTN Program Director, in care of the NCI/DCTD Senior Program Specialist. Page 93 of 241
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PART 1: Overview of <strong>NCTN</strong> <strong>Program</strong> Section V – Other Administrative Considerations<br />
V. Other <strong>NCI</strong> Administrative Considerations<br />
A. <strong>Program</strong> Staff Administration of the <strong>NCTN</strong> <strong>Program</strong><br />
Within <strong>NCI</strong>/DCTD, major scientific policy and programmatic decisions concerning the <strong>NCI</strong> <strong>National</strong> <strong>Clinical</strong> <strong>Trials</strong><br />
<strong>Network</strong> (<strong>NCTN</strong>) <strong>Program</strong> are made only after appropriate consultation with and involvement by the<br />
responsible Lead <strong>NCTN</strong> <strong>Program</strong> Director, the Co-<strong>Program</strong> Directors of the <strong>NCTN</strong> <strong>Program</strong>, the Project Scientists,<br />
<strong>NCI</strong>/DCTD Branch Chiefs and <strong>Program</strong> Chiefs that are involved in the <strong>Program</strong>, and the Associate Director, CTEP,<br />
DCTD, as necessary and appropriate. Routine programmatic administration is the responsibility of the<br />
responsible Lead <strong>NCTN</strong> <strong>Program</strong> Director, who assures uniformity of implementation across the various key<br />
components in conjunction with the Co-<strong>Program</strong> Directors of the <strong>NCTN</strong> <strong>Program</strong> and the Project Scientists.<br />
The Lead <strong>NCTN</strong> <strong>Program</strong> Director or his/her designee has responsibility for addressing and approving noncompetitive<br />
award (Type 5) budget requests, any supplemental budget requests, and new/competitive award<br />
(Type 1) budgets, as well as future Type 2 applications. The responsible Lead <strong>NCTN</strong> <strong>Program</strong> Director will<br />
administer these tasks in conjunction with the Grants Management Specialist in the Office of Grants<br />
Administration (OGA) and will be assisted by the Co-<strong>Program</strong> Directors of the <strong>NCTN</strong> <strong>Program</strong> and the Project<br />
Scientists for the key components of the <strong>NCTN</strong> <strong>Program</strong> as well as the <strong>NCI</strong>/DCTD Senior <strong>Program</strong> Specialist for<br />
the <strong>Program</strong>.<br />
B. Senior <strong>Program</strong> Specialist for the <strong>NCTN</strong> <strong>Program</strong><br />
The <strong>NCI</strong>/DCTD Senior <strong>Program</strong> Specialist for the <strong>NCTN</strong> <strong>Program</strong> works closely with the responsible Lead <strong>NCTN</strong><br />
<strong>Program</strong> Director in reviewing administrative materials supporting Group requests, performing budget analyses,<br />
and facilitating the completion of action items involving coordination between <strong>NCI</strong>/DCTD, the <strong>NCI</strong> Office of<br />
Grants Administration (OGA), and the awardees under the <strong>Program</strong>. The <strong>NCI</strong>/DCTD Senior <strong>Program</strong> Specialist<br />
exchanges information with the <strong>Network</strong> Group Directors of Operations for the key components of the <strong>NCTN</strong><br />
<strong>Program</strong> and OGA staff on administrative changes and priorities.<br />
C. <strong>NCI</strong> Office of Grants Administration (OGA)<br />
The Grants Management Specialist for the <strong>NCI</strong> Office of Grants Administration (OGA) is responsible for the fiscal<br />
and administrative aspects of each application and award. The Grants Management Specialist for OGA works<br />
closely with the responsible Lead <strong>NCTN</strong> <strong>Program</strong> Director and <strong>NCI</strong>/DCTD Senior <strong>Program</strong> Specialist to assure that<br />
appropriate science is funded in accordance with applicable laws, regulations, policies, and peer review<br />
recommendations to the extent that the budget allows and <strong>NCI</strong> priorities dictate.<br />
D. Miscellaneous Budgetary Considerations<br />
1. Carryover Requests<br />
Carry-over requests will be entertained in situations where circumstances prevented funding from being<br />
spent during the budget period for which it was provided and where funding is not replicated in the current<br />
budget year for an ongoing expense.<br />
2. Requests for Non-competing Supplemental Funding<br />
Informal discussions about the possibility of receiving non-competing supplemental funding for special<br />
needs and/or additional funding to cover data collection and management and biospecimen collection on a<br />
per case basis may be initiated by the awardee for the key component of the <strong>NCTN</strong> <strong>Program</strong>. However,<br />
formal requests must be made for funding to be received and must always be countersigned by the<br />
business official responsible for the Cooperative Agreement/grant and the Principal Investigator(s).<br />
Electronic facsimile signatures on documents transmitted via email are acceptable. Most requests,<br />
however, will require the use of a Form PHS 398/SF424 or PHS 2590 to capture the details of the requested<br />
budget. The original should be sent to the responsible Lead <strong>NCTN</strong> <strong>Program</strong> Director, in care of the<br />
<strong>NCI</strong>/DCTD Senior <strong>Program</strong> Specialist.<br />
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