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| calgb.org > About the CALGB > Role of the Central Office |
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Protocol Development
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The Central Office oversees the development of all clinical protocols and updates generated by the scientific committees. This includes protocol development from the concept stage to protocol activation and the production of all protocol documents submitted for Group and NCI approval. The concepts for new studies originated by a member of the CALGB are discussed by the Disease and Modality Committee Cores and then by full committees. The scientific Committee Chairs are responsible for bringing prioritized concepts to the Executive Committee for consideration. Following Executive Committee approval, the Protocol Coordinators assist the Study Chair in development of protocol drafts, following a process for document development that involves the relevant Committee Chair, the responsible statistician, and Data Coordinator, appropriate Chairs of other disease and Modality Committees, other protocol authors, patient advocates and the PIs of the CALGB. Once approves by the NCI, the Central Office officially activates the protocol.
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Regulatory Affairs and Administrative Affairs
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The Central Office ensures that the Group and its investigators are in compliance with the Office of Human Research Protection (OHRP) regulations. The Central Office is in frequent contact with OHRP, NIH, and with member institutions concerning regulations covering clinical trials and maintains appropriate records in order to ensure that the Group is in compliance with current regulations. The Central Office works with OHRP in the submission of all institutional documents (statements of intent) which assures the NIH that an institution agrees to abide by the regulations set forth by OHRP for the protection of human subjects involved in clinical research. Institutional Review Boards certify to the NIH that a mechanism for initial and continuing review of CALGB protocols is in place at their Member Institution or that of their affiliates.
The Central Office represents the interests of the Group in its negotiations with the NCI, pharmaceutical firms, cooperative groups and the public. It provides regular mailings of information essential for the conduct of Group business to the participating members or places such information at the CALGB web site, schedules meetings of the Executive Committee, and communicates with the Group membership by electronic mail, web postings, fax, courier, and mail as appropriate.
The Central Office is responsible for all meeting arrangements, not only for the semi-annual Group meetings, but additional meetings per year of Disease, Modality, and Administrative Committees, ad hoc committees, etc. The Central Office maintains a roster of all CALGB member institutions and participants.
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Fiscal Affairs
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Management of CALGB fiscal affairs is a primary responsibility of the Central Office, headquartered at the University of Chicago. Activities include tracking potential sources of grant support and conveying information to investigators regarding the availability of funding opportunities that are relevant to CALGB research. The Central Office also organizes and coordinates the development of CALGB budgetary proposals from the University of Chicago and provides consultation services to member institutions submitting CALGB-related funding proposals and progress reports. The Central Office acts as a liaison between member institutions and granting agency officials to address issues or questions related to pre- or post-award management of the Group’s funding, including questions regarding subcontracts that fund the Group's centralized services, allowable direct and indirect costs, prior approvals and rebudgeting, and other compliance issues. Reports on scientific progress and financial status are prepared by the Central Office for all components, including subcontracts, of grants awarded to the University of Chicago on behalf of CALGB. The Central Office coordinates a travel expense reimbursement program for CALGB Disease, Modality, and Administrative committee and Working Group members who attend the semi-annual Group meeting and Core meetings. The Central Office also coordinates a per-accrual payment program, using funds provided by the NCI and other federal agencies, to defray the costs incurred by CALGB institutions in treating and following patients on selected CALGB clinical trials.
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For More Information Contact:
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CALGB Central Office
230 West Monroe, Suite 2050
Chicago, IL 60606
Phone: 773-702-9171
Fax: 312-345-0117
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