12.01.2013 Views

NCI National Clinical Trials Network (NCTN) Program Guidelines

NCI National Clinical Trials Network (NCTN) Program Guidelines

NCI National Clinical Trials Network (NCTN) Program Guidelines

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan<br />

<strong>Network</strong> Group Ops Center<br />

� Travel for <strong>Network</strong> Group scientific and administrative committee members to<br />

committee meetings held separately from major <strong>Network</strong> Group meetings;<br />

� Travel for protocol chairs and others who must perform quality assurance functions<br />

away from their home institution;<br />

� Travel for persons on the Operations Center staff who must attend the <strong>Network</strong> Group's<br />

meetings;<br />

� Travel for the <strong>Network</strong> Group senior leadership to attend <strong>NCI</strong>/DCTD – <strong>Network</strong> Group<br />

<strong>NCTN</strong> Leadership Management Committee meetings for the <strong>NCTN</strong> <strong>Program</strong>;<br />

� Travel associated with onsite audit program (see Auditing under Personnel above); and<br />

� A reasonable number of carefully justified trips for provisional <strong>Network</strong> Group members<br />

or other associated stakeholders (e.g., patient advocates) to attend <strong>Network</strong> Group<br />

meetings in order to encourage participation and assure input from all relevant<br />

modalities and stakeholders in clinical trial research.<br />

f) Alterations and Renovations: Costs for alterations and renovations are not<br />

allowable under the <strong>NCTN</strong> <strong>Program</strong>.<br />

g) Other Expenses: Research costs due to other expenses include those related to<br />

communication and information dissemination among other components of the<br />

<strong>Network</strong> Group as well as with sites accruing patients to <strong>Network</strong> Group trials. Also<br />

included are costs of equipment rental and maintenance (copiers, telephones,<br />

computers), postage, copying and printing, etc., justified quantitatively on the basis<br />

of previous experience, where relevant.<br />

Applicants can also include expenses related to restricted capitation for follow-up on<br />

phase 3 legacy studies from the former <strong>NCI</strong>-sponsored Cooperative Group <strong>Clinical</strong><br />

<strong>Trials</strong> <strong>Program</strong>; however, such requests must be accompanied by a detailed budget<br />

justification (not to exceed 1 page in the budget section) and appliy only to legacy<br />

phase 3 studies for a maximum of 5-years at $50 per year per patient for accrual from<br />

sites that were NOT institutional U10 members or CCOPs/MB-CCOPs under the legacy<br />

program since institutional U10 members and CCOPs/MB-CCOPs did not receive<br />

follow-up payments under the legacy program. Applicants can also request funding<br />

for tumor banking activities that were previously covered in the Operations Center<br />

grants of applicants that participated in the former <strong>NCI</strong>-sponsored Cooperative Group<br />

<strong>Clinical</strong> <strong>Trials</strong> <strong>Program</strong> (and are not yet covered by their current Tumor Banking R24<br />

grant); however a detailed budget justification must be provided with this request (up<br />

to a 1 page maximum in the budget section) and these costs CANNOT cover reference<br />

laboratory activities.<br />

h) Consortium/Contractual Costs: Research costs include financial support to<br />

<strong>Network</strong> Group members who are responsible for committees or scientific services<br />

and this financial support is usually provided through consortium/contractual<br />

arrangements. Consortium/contractual cost for each participant require a separate<br />

budget page, with appropriate justification. Indirect costs to<br />

consortium/contractual participants are included in the direct costs for the <strong>Network</strong><br />

Groups Operations Center budget.<br />

<strong>Network</strong> Groups are encouraged to structure their organization in a manner which<br />

minimizes the burden of indirect costs on the overall <strong>Network</strong> Group budget. The<br />

“per case management” funding described in Part 2 – Section II.B.1.4 below) should<br />

also be included in the category of consortium/contractual costs for the <strong>Network</strong><br />

Group Operations Center budget.<br />

1.3 Patient Care Costs<br />

<strong>NCI</strong> will not support costs associated with routine patient care. Only in the most unusual<br />

circumstances would a <strong>Network</strong> Group clinical trial require interventions beyond those<br />

considered appropriate for the care of cancer patients. In those circumstances, a <strong>Network</strong><br />

Page 104 of 241

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!