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05/30/2008
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7:00 AM - 4:00 PM Alumni Auditorium
New York Metro Chapter of ACRP presents:
Tools for Improving Site Performance.
Presented by
John Rowell, RN, MSN, CCRC.
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02/26/2008
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3:30 PM Alumni Auditorium
Compliance for Clinical Trials.
Presented by
Debra Fitzpatrick,
Manager,
Risk and Research Compliance,
Clinical Trials Office.
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01/15/2008
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08:00 AM Alumni Auditorium
Fifth annual Leahey Lecture.
Barry S. Coller, M.D., will present the fifth annual
lecture honoring Michael Leahey and Dr. Edward Leahey, Jr.
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11/20/2007
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Budgeting for Clinical Trials – Best Practices
(IRB Monthly Investigator Meeting)
3:30-4:30PM,
Pharmacology Library,
Black Building 7-724
| Presenters: |
Richard Hlenski, Director of Finance |
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Lourdes Vasquez, Senior Project Officer - Budgets |
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10/15/2007
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Medicare Centralization of IDE requests for Investigational Device Trials.
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06/07/2007
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CTO Telephone and E-mail Directory.
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06/06/2007
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Medicare Coverage and Payment of Investigational Device Trials
Category B FDA approval confirms a device's eligibility for Medicare
coverage and reimbursement, it does not result in automatic
reimbursement by Medicare contractors. Our local Medicare contractor
National Government Services (NGS) is responsible for the hospital
services at New York Presbyterian and the physician services at Columbia
University Medical Center. NGS must review the device and its use to
make a final determination on reimbursement during the clinical trial.
Click
here
for details.
To facilitate their review of our request for reimbursement approval,
you should use
this template
to develop the cover
letter that is jointly submitted by the Principal Investigator and New
York-Presbyterian Hospital.
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03/12/2007
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Investigators and Coordinators:
this document
summarizes basic information required
when preparing to participate in an investigational device trial.
Instructions include
•
how to do the CTO submission
•
the need for open communication between
the PI
and the hospital chargemaster team
•
compliant billing instructions
Clinical Trials and Investigational Devices
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11/09/2006
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On Thursday, October 26, 2006, Dr. Paul Deutsch, Carrier Medical
Director for Empire Medicare Services, gave an in-service to our
clinical research community involved in investigational device clinical
trials.
The topic was "Medicare Coverage of IDE and Clinical Trials".
Attendees included researchers, coordinators, and administrative staff
from Anesthesiology, Cardiology, Neurology and Neurosurgery,
Ophthalmology, Orthopedics, Pediatrics, Radiology, and Surgery.
Topics discussed were: Investigational Device Exemptions - Catetory B and
Category A, Humanitarian Devices and routine costs and requesting
reimbursement for clinical trials.
Medicare is permitted to reimburse
for the routine costs of qualifying clinical trials as well as certain
FDA-approved and IRB-approved investigational devices.
Dr. Deutsch's
presentation was thorough, including many references to outside sources
for additional information.
To view the presentation, click
here.
If you have further
questions or comments, please contact the Clinical Trials Office at
ctoriskmanager.
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11/08/2006
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Browse studies recruiting healthy volunteers.
More...
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09/19/2006
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The Clinical Trials Office has established a dedicated Help Desk for online submissions
at 212-305-9517.
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06/21/2006
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Medicare regulations for FDA-approved Investigational Device Exemption (IDE) Studies.
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04/17/2006
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Investigators and coordinators: you may now
submit
study-related
documents that require
Spanish translation
to the
Hispanic Translation Center.
See instructions here.
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01/30/2006
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Investigators: you may now grant your coordinators, or other designated staff,
access to your
Pre-
and
Post-
award Reports.
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01/24/2006
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NIH
, in conjunction with
Grants.gov
, has prepared a training video and related documents
for the upcoming electronic submission, now known as the
SF424 (R&R).
More . . .
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01/09/2006
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RASCAL User's Guide v2.1
More . . .
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12/02/2005
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RASCAL HIPAA Manual
More . . .
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09/20/2005
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Recent settlements between medical institutions and the U.S. Department of Justice over
alleged misuse of federal grant money
More . . .
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06/20/2005
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RASCAL User's Guide
More . . .
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05/10/2005
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Insurance Coverage and Clinical Trials
More . . .
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03/01/2005
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Western IRB multi-center trial submission instructions
More . . .
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02/02/2005
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CTO announces Biostatistical Consulting Service (BCS).
More . . .
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