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The
CTSU reimbursement process has been developed to facilitate
payment to the investigators and institutions for their time
and effort for enrolling and managing patients on CTSU trials.
Reimbursement
procedures for Cooperative Group member sites and affiliate
sites that are not Community Clinical Oncology Program (CCOP)
members are highlighted below (see the next module for information
on CCOP crediting).
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In
situations where an institution is a member of a Cooperative
Group that is leading the trial, or for studies where previous
Intergroup agreements are in place between the lead Group and
the Group of which the institution is a member, enrollments
will not be permitted through the CTSU and no reimbursements
will take place through the CTSU. In other words, with rare
exceptions, Lead Group members should enroll to their own Group
studies via their own Group mechanisms, not via the CTSU. |
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For
studies endorsed by the
Cooperative Group receiving accrual credit, the patient enrollment
will be reimbursed from the budget of the Group receiving credit,
not from the CTSU. Studies endorsed by NCIC-CTG will have enrollments
reimbursed from the CTSU budget. |
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For
studies not endorsed by the Cooperative Group receiving accrual
credit, the patient enrollment will be reimbursed from the CTSU
budget. The payment will be made to the credited Group, who
will then pass payment along to the enrolling institution. |
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CTSU
reimburses each enrollment at around $2,000 per patient. (NOTE:
This is the standard reimbursement amount, which is periodically
reevaluated.) |
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If
trial activities are being supported by additional funding in
Group Studies (e.g., Pharmaceutical or Quality of Life), the
additional compensation will be defined for each trial and distributed
in the same manner as the reimbursement. |
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One
accrual credit is awarded per patient registration through the
CTSU. |
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The
clinical site uses the CTSU
Patient Enrollment Transmittal Form to designate the
Group receiving the accrual credit. |
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The
CTSU notifies the Cooperative Group receiving credit of each
enrollment. |
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The
Group named as receiving credit disperses the funds to the
Investigator or institution based on standard procedures outlined
in the specific contracts and current reimbursement rates.
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| U.S.
Cooperative Group Sites/Members Located Outside the U.S. and
Canada |
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CTSU
participation by Cooperative Group member sites located outside
the U.S. or Canada is limited to CTSU menu trials which have
been endorsed by the sites' member group. Reimbursements will
be made by the Group endorsing the trial.
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Endorsement
is the process by which a Cooperative Group provides scientific
and financial support for a trial led by another group.
This is done to encourage participation in the trial by
the endorsing Group's member sites.
Endorsement
of trials implies the following commitments or actions:
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The
Disease Committee Chair of the endorsing Group designates
a committee member to serve as a study co-chair on a CTSU
menu trial.
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The
designated co-chair's responsibilities are to participate
in the analysis of the study results, review amendments, promote
the study within their own Group, provide updates within the
Group, and contribute reports.
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The
endorsing Group will be responsible for auditing patient cases
credited to that Group upon enrollment.
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The
endorsing Group will be responsible for paying the per-patient
reimbursement for all enrollments credited to that Group.
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| CTSU
Independent Clinical Research Sites- CICRS |
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Investigators
who are not associated with a Cooperative Group (CTSU Independent
Clinical Research Sites -CICRS) are reimbursed for patient
enrollments by a different mechanism.
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The
CICRS must qualify as a CTSU member.
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A
contract between the CICRS and the CTSU (Coalition) must be
signed before the site can enroll patients through the CTSU.
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The
CTSU pays $2,000 per patient registration.
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If
the study requires activities that are being supported by
additional funding, then the CTSU may be able to provide additional
compensation. The specifics of this compensation are defined
for each study.
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The
CTSU makes reimbursements directly to the site for all patients
registered through the CTSU based on standard procedures and
current reimbursement rates.
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| Accrual
Credits |
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ACOSOG:
will accept credits for enrollments on most solid tumors,
but not for enrollments on hematologic tumor studies.
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CALGB:
will accept credits for enrollments on all diseases.
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ECOG:
will accept credits for enrollments on all diseases.
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GOG:will
accept credits only for enrollments on GYN cancer studies.
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NCCTG:
will not accept credits for hematologic, GYN, or GU cancer
protocols.
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NCIC:
will accept credits for enrollments on all diseases.
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NSABP:
will accept credits for enrollments only on breast and colorectal
cancer studies.
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RTOG:
will accept credits for enrollments on most solid tumors,
but not on hematologic tumor studies.
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SWOG:
will accept credits for enrollments on all diseases.
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