NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Canadian Collaborating Clinical Trials Network
Collaborating Clinical Trials Network should conduct a comprehensive review of its
membership and provide updated auditing information for all Participating Sites and
affiliates to the NCI/DCTD Senior Program Specialist two months prior to the anticipated
award. This information should be provided in tabular format as part of Just-In-Time
Information and should include the following: (1) date of affiliation with or termination from
the Canadian Collaborating Clinical Trials Network; (2) accrual for the immediate preceding
36 months broken down by year; (3) the projected accrual for the upcoming year; (4) the
date of the institution’s last audit; and (5) the date or projected month/year of the next
proposed audit. See Part 4 – Appendices – Section II.A.9.
4.4 Provision of Funds to Member Institution/Sites for Per Patient Data Management
& List of Legacy Trials
The Canadian Collaborating Clinical Trials Network provides funds to member
institutions/sites for accruals (non-Lead Academic Participating Sites and non-CCOP/MB-
CCOP institutions) via per-accrual reimbursement mechanisms (e.g., purchased service
agreements or subcontracts). The following information must be provided as Just-In-Time
information by a scheduled date to be specified by NCI/DCTD that reflects the patient enrollment the
Canadian Collaborating Clinical Trials Network (CCCTN) used to estimate its budget (i.e., the accrual
to all NCTN trials that the CCCTN thought its member would credit to the CCCTN and thus would
need to be paid via the CCCTN’s capitation funding). This would include both trials led by the CCCTN
as well as accrual credited to it for trials led by other Network Groups. NCI/DCTD will use this
information to adjust the final funding plan for the CCCTN award. This is essentially the “Accrual
Input Table” described on page 236 of these Guidelines and includes information on for the
upcoming 5-year project period for the estimated number of per patient accruals by category (basic
intervention – therapeutic including pilot studies; basic intervention –advanced imaging; screening;
and biospecimen accrual counted as 1 collection by enrolled patient by trial) by member institution
with corresponding NCI institution code.
In addition, the CCCTN applicant will also be requested to provide the total number of patients it
anticipates will be accrued to trials it leads over the 5-year project period - i.e., accrual to trials it
leads from all institutions (CCOP and non-CCOP) that credit the CCCTN with the accrual as well as all
institutions (CCOP and non-CCOP) that credit other Network Groups with the accrual.
Lastly, the CCCTN will also be requested to supply a list of legacy trials that it wishes to transition to
the new NCTN program. Only studies previously supported under the NCI-sponsored Cooperative
Group Clinical Trials Program funded by the Division of Cancer Treatment and Diagnosis (DCTD) can
be transitioned to the new NCTN program. The CCCTN should specify all legacy trials that do not
have a status of “complete” in the NCI/DCTD enterprise system, both open and closed, this it wishes
to transition to the new program. The Network Group Operations Center must specify which trials it
anticipates will still be open to accrual at the time of transition to the new program.
4.5 Data and Safety Monitoring Boards/Plans
The Canadian Collaborating Clinical Trials Network should have a Data and Safety and
Monitoring Board (Data Monitoring Committee) policy for randomized phase 2 and phase 3
NCTN trials that complies with the “NCI NCTN Program Data and Safety Monitoring Board
Policy” as provided in Part 4 – Appendices – Section VIII of these Guidelines. In addition, the
Network Group Operations Center must have Data and Safety Monitoring plans for all other
Network Group studies (e.g., phase 1 and phase 2 studies, pilot studies, etc.) that comply
with the NIH policy for data and safety monitoring, posted on the NIH website at:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html, with additional description
at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. These
policies/plans should be provided in the research application; however, prior to funding of
an award, all Data and Safety Monitoring Board (Data Monitoring Committee) policies/plans
will also need to be reviewed and approved by NCI/DCTD program staff prior to funding of
an award to ensure that they are in compliance with NCI/NIH regulations.
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