CCOP Agreement Letter - Southeast Clinical Oncology

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CCOP Consortium Agreement
Southeast Cancer Control Consortium, Inc. (SCCC)
James N. Atkins, M.D., Principal Investigator
The following letter of agreement is written to confirm and facilitate the
cooperation of the SCCC institutions* in the conduct of the NCI Community Clinical
Oncology Program (CCOP) via a consortium agreement with the Southeast Cancer Control
Consortium, Inc. (SCCC), of Winston-Salem, North Carolina. The agreement is
intended to assure compliance with all requirements of the National Institute of
Health (NIH), the National Cancer Institute (NCI), Office for Human Research
Protections (OHRP), the Food and Drug Administration (FDA), and the CCOP Research
Bases to promote efficient and effective collaboration in the conduct of cancer
clinical trials and cancer control programs.
Research Base Resource Affiliations
The Southeast Cancer Control Consortium (SCCC) will utilize NCI-approved clinical
trials and cancer control studies from the following research bases in the conduct
of projects sponsored for the CCOP program:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
Cancer and Leukemia Group B (CALGB),a national multispecialty,
multidisciplinary cooperative group.
Comprehensive Cancer Center of Wake Forest University (CCCWFU),a
comprehensive cancer center for treatment and cancer control studies.
Cancer Trials Support Unit (CTSU), a national cooperative group
sponsored by the NCI for “inter-group studies”.
The National Surgical Adjuvant Breast and Bowel Project (NSABP), a
national cooperative group for treatment of breast and bowel cancers,
breast cancer prevention studies, and cancer control studies.
Radiation Therapy Oncology Group (RTOG), a national multidisciplinary,
multispecialty cooperative group for clinical trials and chemoprevention
studies.
Southwest Oncology Group (SWOG), a national multispecialty,
multidisciplinary cooperative group.
University of Rochester Cancer Center (URCC), a comprehensive cancer
center for cancer control studies.
University of Michigan Cancer Center (UMCC), cancer control studies
SCCC Community Representatives to the Board of Directors
James N. Atkins, MD will be the SCCC Principal Investigator. Each community will be
represented in the SCCC organization by a board member, a physician designated in
consultation with the community members and the SCCC Operations Office. This board
will meet at required intervals, but at least bi-annually, to review the program, to
agree upon priorities in studies, to promote the most effective utilization of
resources, and to avoid competitive bias among programs sponsored via the SCCC.
Confidential Participant Information
SCCC agrees to use and disclose “protected health information” of patients as
defined in 45 CFR § 164.501 that SCCC receives from each community
component/affiliate or that SCCC creates or receives on behalf of each community
component/affiliate (collectively, the “Information”) only to the extent necessary
(i) to perform its specific obligations under this Agreement, and (ii) for its own
management and administration and to carry out its legal responsibilities in
compliance with 45 CFR § 164.504(e)(2)(i)(A) and (e)(4). The parties agree that all
of the “business associate” requirements as set forth in 45 CRF 164.504(e)(2)(ii),
including contract termination rights, are hereby incorporated in this Agreement by
reference. Notwithstanding anything to the contrary herein, this Agreement shall
not be deemed to authorized SCCC to use or disclose Information in a manner that
would violate HIPAA Privacy Rules, 45 CFR § 164.501 et seq., if done by a HIPAA
covered entity.
************************************************************************************
SCCC Office Use Only:
*Individual agreements are on file in the SCCC Operations Office. Signature pages
for each community are appended at the end of this agreement.
10/05
Page 1 of 4
Quality Control Assurances/Audits
Assurances from each community component (hospital, clinic, or private office) are
required by the NIH, NCI, and OHRP. Failure to maintain assurance can result in
termination of the total program by the NCI. Each community component/affiliate
must comply with the assurances provided to and approved by the OHRP(45 CFR 46). No
protocol should be applied to patient treatment without completion of full board
review by the local institutional review board (IRB), and an RSS 2.0 form completed
and submitted to the SCCC Operations Office prior to patient registration.
On-site access to all procedures, medical records, and other data must be available
to quality assurance auditors who may visit the community representing the NCI, the
FDA, Research Bases (CALGB, CCCWFU, CTSU, NSABP, RTOG, SWOG, URCC, UMCC), the SCCC,
OHRP, and/or pharmaceutical companies supplying drugs via the NCI.
The institution will submit to the SCCC, assurances required by the NIH as follows:
1.
Appropriate review of each protocol and updates requiring IRB approval or
project to assure local approval as required by the OHRP.
2.
To make available all records required for quality assurance review of
clinical activities related to the program, and qualifications of
physicians as required by the NIH, NCI, FDA, and other regulatory
agencies.
3.
All subjects for cancer clinical trials and participants in cancer
control protocols must review and sign an informed consent before
participating in a protocol. A copy of the informed consent will be
given to the patient, a copy forwarded to the respective research base
operations office (if required) and the original will be maintained in
the patient's local protocol file.
4.
Control inventory and dispensing of investigational drugs.
5.
Continuous update on the incidence of cancer in the community
participating in the program.
6.
The development and maintenance of American College of Surgeons Cancer
Program in the individual member hospitals.
7.
Inclusion of women and minorities; no discrimination based on age.
Funding
I.
NCI/SCCC
The SCCC, which is funded by the NCI for the conduct of CCOP activities, will
maintain a headquarters office for coordination and supervision of the program.
Personnel from the Operations Office will be available for support/education for
physicians and non-physician participants to assure enthusiastic and competent
conduct of the program. Registrations to both cancer clinical trials and cancer
control activities will be conducted via the registrar at the appropriate research
base office.
Community components/affiliates will be supported by quarterly reimbursement by
check from the SCCC for each eligible/evaluable registration to treatment and cancer
control protocols. The amount of reimbursement depends on funding from the NCI. The
SCCC/CCCWFU database (ORIS) will be used to determine the number of qualified
patients/participants for which the community is due reimbursement. (The SCCC
database is Year 2000 compliant).
Should registrations exceed the funding allowed for community reimbursement, a
request to NCI for additional funding will be made; however, there is no assurance
that additional funding will be available.
10/05
Page 2 of 4
Reimbursement for registrations should be used as a charge-back against individual
community expenses incurred for participating in the CCOP program. Expenditure of
grant funds at the community level is subject to review and approval by the SCCC
Operations Office auditor.
II.
Community
Each new community/institution must invest $2,500.00 in order to become a member of
the CCOP. This investment is used by the SCCC Operations Office to defray the
expenses incurred in implementing a new site and training new community personnel.
Annual membership fee is $50/each physician, due upon application for membership and
on June 1st annually thereafter.
Community Personnel
Each SCCC community institution will require a physician "Community Leader" as the
sponsoring coordinator of the program in the community, as well as physicians who
participate. There will also be a nurse or clinical research professional to assume
the role of "Study Coordinator." These designated local CCOP leaders will be
responsible for communications related to protocols, registration of patients,
collection of data in proper format, and local educational activities to support the
full development of a program of clinical trials and cancer control projects. Each
community may require additional staff for data management and clerical support of
the program, depending upon the activity in the community. Payments and benefits
for these core personnel will be assumed by the local institution, in compliance
with their institutional policies.
Inasmuch as communication between the community members and SCCC is essential to the
conduct of this program, all community and Operations Office personnel will seek to
maintain an alert, timely communication and data processing program.
Activity Credits
The program requires specific credits for clinical trials and cancer control
registrations as established by the NCI-CTEP and DCPC Cancer Therapy Evaluation
Program (CTEP) and Division of Cancer Prevention and Control (DCPC). The SCCC is
obligated to attain its assigned quota. Future funding depends upon meeting the
registration requirements mandated by the NCI.
Failure to provide eligible/evaluable registrations may result in suspension of
registration privileges until a plan is submitted for correcting the registration
deficit.
Duration of Agreement
This agreement is goes into effect on the date of approval of membership
application, and continues through 2010. The agreement may be extended thereafter
by mutual agreement of the participants.
Withdrawal from SCCC Program
The NCI requires written notice of withdrawal from the program. This must be
provided to the SCCC Operations Office by any physician or institution wishing to
withdraw from participation in the program.
Inventions/Patents-N/A
Ownership and Disposition of Data
All data generated via participation in the CCOP research base protocols is the
property of the research bases. Confidentiality of data is assured. Data will be
submitted to the research base statistical headquarters for analysis and
publication. SCCC physicians, nurses, and CRPs will not publish data independently
of the research bases.
10/05
Page 3 of 4
Acceptance
The undersigned, assuring that they are informed of the nature of this program and
the benefits the community gains through improved cancer treatment and the
prevention of cancer through education, and early detection programs, enter into
this program confirming their enthusiastic support and cooperation.
Compliance with NIH Consortium Agreements
The appropriate programmatic and administrative personnel of each organization
involved in this grant application are aware of the NIH consortium agreement policy
(Attachment II) and are prepared to establish the necessary inter-institutional
agreement(s) consistent with that policy.
______________________________________
____________________________
Community Physician Leader
Date
______________________________________
____________________________
Hospital Administrator Signature
Date
______________________________________
Hospital Administrator Printed Name
Community
_______________________________________
Hospital
_______________________________________
James N. Atkins, MD
Principal Investigator
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____________________________
Date
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