NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Canadian Collaborating
Clinical Trials Network
6 Specific Awardee Rights & Responsibilities - Canadian Collaborating Clinical Trials Network
With respect to the Terms and Conditions of Award, “Canadian Collaborating Clinical Trials Network” refers
to the organizational structure which is composed of the key personnel (including the scientific and
administrative leaders of the organization and its scientific research and administrative committees) and
the member institutions/sites (including the institution/site physicians and clinical research associates),
responsible for implementing clinical trials and collaborating on research goals of the NCTN Program. In
addition, throughout these Terms and Conditions of Award, “Canadian Collaborating Clinical Trials
Network” refers to all of its member institutions/sites as well.
6.1 Overall Rights and Responsibilities
The Canadian Collaborating Clinical Trials Network is subject to all the Awardee Rights and
Responsibilities outlined in these Guideline in Part 1 - Section IV.B.1. (Network Group Operations
Centers) and Part 1 - Section IV.B.2. (Network Group SDMCs) for any NCTN trials the Canadian Network
participates in and/or leads, although the volume of clinical trials, accrual, and collaborations would be
expected to be more limited for the Canadian Network. There are, however, special considerations for
the Canadian Collaborating Clinical Trials Network related to regulatory oversight of NCTN trials in
Canada and biospecimen collection as outlined below.
6.2 Regulatory Oversight
The Canadian Collaborating Clinical Trials Network would be expected to establish relationships with
U.S. Network Groups to provide appropriate regulatory oversight for U.S. Networks Group trials
conducted in Canada, when needed. In some cases, this oversight may be performed by a U.S.
Network Group; however, it is anticipated that the Canadian Collaborating Clinical Trials Network will
play an important role in providing this type of regulatory oversight when need for both U.S. adult and
pediatric Network Groups for trials open in Canada.
6.3 Biospecimen Collection and Tumor Banking
For NCTN trials led by U.S. Network Groups, biospecimens from member institutions/sites of the
Canadian Collaborating Clinical Trials Network should be sent to the associated tumor bank for the U.S.
Network Group or to a specified laboratory for analysis during the course of the trial (e.g., central
laboratory for assessment of an integral biomarker).
For NCTN trials led by the Canadian Collaborating Clinical Trials Network, if biospecimens are collected
for banking that are funded by NCI/DCTD, arrangements would be made for the biospecimens to be
banked in collaboration with a tumor bank associated with a U.S. Network Group. Alternatively, these
specimens may be stored in a tumor bank of the Canadian Collaborating Clinical Trials Network for an
NCTN trial that the Canadian Network leads if the Canadian Network has a tumor bank and the
collection and storage at that bank is approved by the Lead NCTN Program Director in consultation with
the NCI Cancer Diagnosis Program Associate Director, Program Director of the NCTN Tumor Banking
grant, and the CTEP Associate Director in writing (and with CTEP approval of an amendment to the trial
that states that the biospecimens will go to the Canadian Collaborating Clinical Trials Network bank).
The Canadian Collaborating Clinical Trials Network as part of the NCTN Program is also eligible to apply
for BIQSFP funding (see http://biqsfp.cancer.gov/). Any biospecimens collected under a funded BIQSFP
application that are later “banked” must also follow all the rules and regulations related to any
biospecimens collected in association with an NCTN trial as outlined in the Terms and Conditions of
Award for Network Group Operations Centers (see Part 1 - Section IV.B.1.5.7. of these Guidelines).
Regardless of the source of funding for collection/banking of biospecimens by the Canadian
Collaborating Clinical Trials Network, study proposals for use of biospecimens collected in association
with a NCTN clinical trial would be required to be reviewed by CTEP’s Protocol Review Committee or an
NCI/DCTD-approved NCTN Correlative Science Committee as outlined in Part 1 – Section IV.C.3. In
addition, the Canadian Collaborating Clinical Trials Network is required to have a Biospecimen Sharing
Policy (the same requirement as for the U.S. Network Groups) that reflects this requirement.
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