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 – VII. NCTN Program Data & Safety Monitoring Policy for Phase 3 & Randomized Phase 2 Trials Table of Membership of DSMB/DMC and Attendance at Sessions If the DSMB/DMC has voting members who are also members of the Network Group, the majority of voting DSMB/DMC members cannot belong to the Network Group and voting quorums for a DSMB/DMC meeting require that the majority of voting members not belong to the Network Group. DSMB/DMC Membership Type Voting member of DSMB/DMC NCI/DCTD (non-voting) member of DSMB/DMC Study statistician Designated Network Group Statistician (non-voting) Designated Network Group Chair or any member of the executive leadership Open session Present Present Present Present Present (if he/she desires) Closed Session Present (except if member of the study team or leadership of the disease committee for the study under consideration) Present Present Present Absent Executive Session Present (except if member of the study team or leadership of the disease committee for the study under consideration) Present Absent Present (except if study statistician for the study under consideration, in which case, the Designated Network Group Statistician can name another statistician from the Network Group as his/her non-voting designee for the executive session) Absent Page 232 of 241
Part 4: Appendices – IX. Common Budget Outline IX. Common Budget Outline for Network Group Operations Center Applications – Suggested Format (Submitted in Network Group Ops Center Applications Only) Heading for All Costs (except for per case reimbursement) FTEs Salaries & Wages Fringe Consultants Equipment Supplies Travel INFRASTRUCTURE COSTS A. Group Leadership 1. Group Chair and Vice Chairs (include all Multiple PI(s)/PD(s) on grant application) Salary, fringe, travel and consortium/contractual indirect costs for Group Chair and any Vice or Deputy Chairs 2. Executive Medical Officers Salary, fringe, travel and consortium/contractual indirect costs for physicians who have oversight responsibilities for scientific activities SUBTOTAL - GROUP LEADERSHIP B. Scientific Leadership 1. Scientific Committee Leadership Salary, fringe, travel and consortium/contractual indirect costs for Chairs, Vice and Deputy Chairs, Subcommittee Chairs 2. Administrative Committee Leadership Salary, fringe, travel and consortium/contractual indirect costs for Chairs, Vice and Deputy Chairs, Subcommittee Chairs 3. Protocol Chairs Salary, fringe, travel and consortium/contractual indirect costs or fixed payments for protocol chairs SUBTOTAL - SCIENTIFIC LEADERSHIP C. Group Administration Consortium/ Contractual Alterations/ Renovations Other Indirect TOTAL 1. General Administration Salary, fringe, office costs, travel and consortium/contractual indirect costs for administrative management, Chair's Office, if applicable, and meeting support 2. Finance/Contracting Salary, fringe and consortium/contractual indirect costs for finance and contracting staff 3. IT Support Salary, fringe, consortium/contractual indirect costs or other costs for administration IT support 4. Rent Rental costs paid for Group space from direct dollars SUBTOTAL - GROUP ADMINISTRATION Page 233 of 241
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Part 4: Appendices – VII. <strong>NCTN</strong> <strong>Program</strong> Data & Safety Monitoring Policy<br />
for Phase 3 & Randomized Phase 2 <strong>Trials</strong><br />
Table of Membership of DSMB/DMC and Attendance at Sessions<br />
If the DSMB/DMC has voting members who are also members of the <strong>Network</strong> Group, the majority of voting<br />
DSMB/DMC members cannot belong to the <strong>Network</strong> Group and voting quorums for a DSMB/DMC meeting<br />
require that the majority of voting members not belong to the <strong>Network</strong> Group.<br />
DSMB/DMC<br />
Membership Type<br />
Voting member of<br />
DSMB/DMC<br />
<strong>NCI</strong>/DCTD (non-voting)<br />
member of DSMB/DMC<br />
Study statistician<br />
Designated <strong>Network</strong><br />
Group Statistician<br />
(non-voting)<br />
Designated <strong>Network</strong><br />
Group Chair or any<br />
member of the executive<br />
leadership<br />
Open<br />
session<br />
Present<br />
Present<br />
Present<br />
Present<br />
Present<br />
(if he/she<br />
desires)<br />
Closed Session<br />
Present<br />
(except if member of the study<br />
team or leadership of the disease<br />
committee for the study under<br />
consideration)<br />
Present<br />
Present<br />
Present<br />
Absent<br />
Executive Session<br />
Present<br />
(except if member of the study team<br />
or leadership of the disease<br />
committee for the study under<br />
consideration)<br />
Present<br />
Absent<br />
Present<br />
(except if study statistician for the<br />
study under consideration, in which<br />
case, the Designated <strong>Network</strong> Group<br />
Statistician can name another<br />
statistician from the <strong>Network</strong> Group<br />
as his/her non-voting designee for the<br />
executive session)<br />
Absent<br />
Page 232 of 241
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