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| Regulatory and Fiscal Management |
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The Berman Center assists investigators to submit applications for funding,
to prepare progress and final reports to study sponsors, and to comply
with participant protection regulations. |
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Proposal Preparation |
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The Berman Center constructs comprehensive
grant applications for public, industry, and foundation funding,
complying with all sponsor requirements. |
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For applications submitted to the National Institutes of Health (NIH),
the Berman Center collects all necessary institutional documentation.
Staff compile NIH-formatted biosketches for all key personnel, and if
a formatted biosketch is unavailable, Berman Center staff will redesign
a CV into the required format. Staff prepare budgets and their justifications,
often assisting subcontracting organizations who are inexperienced with
the process (eg. primary care clinics, state or county health departments,
non-profit community organizations). If necessary, staff will assist
investigators and subcontractors to provide required descriptions of
their operating environments. |
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The Berman Center’s team of scientific writers and research assistances
also helps prepare the textual portions of proposals by conducting literature
searches, collecting and checking cited references, editing, and, in some
cases, writing sections of a proposal’s narrative. These staff can
complete all required NIH Anticipated Enrollment Tables, showing expected
distribution of participants by race, ethnicity, and gender. |
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Berman Center staff can compile all necessary appendices for proposals,
including necessary letters of intent and support, sample consent forms,
and other supporting documentation. |
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Regulatory Management |
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The Berman Center assists investigators to comply
with all regulatory requirements. Staff draft and/or edit participant
consent forms and IRB applications and ensure that the process
of obtaining IRB approval operates smoothly. Staff maintain up-to-date
knowledge of federal protection and privacy regulations. |
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Fiscal Management |
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The Berman Center helps investigators ensure that
their studies are adequately funded by helping them prepare realistic
budget requests. These budgets take into account all direct and
indirect costs expected to be incurred by the study, including
salaries and fringe benefits with expected increases built in;
costs for office space and equipment, such as furniture and telephones;
computing costs; advertising and other recruitment costs; costs
of laboratory measurements, participant parking, etc. Once studies
are funded, Berman Center accountants maintain careful records
of study expenditures and reconcile study accounts with their budgets
and available funds. Accountants also prepare budgets submitted
with progress reports, requests for no-cost extensions, and final
reports. |
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