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Orientation for New Clinical Research PERSONNEL Module 4. Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research Professionals. Overall Agenda for Orientation. Module 1: Introduction to Clinical Research, Education, and IRB
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NC TraCS Institute
UNC Office of Clinical Trials
UNC Network of Clinical Research Professionals
Ed Finerty, NC TraCS Institute
Laura Cowan, NC TraCS Institute
Clinical Research Management System (CRMS)
A set of tools to help clinical research teams
A UNC built application
A place to test out planned studies
CRMS Electronic 1572, protocol, and investigator brochure uploading
You can request a pharmacist online through CRMS
Electronic Protocol Intensity Worksheet
New CRMS Medication Wizard
Fill all visits or procedures by cohort from one screen
Export to Excel
Sort by IRB expiration date
If an eIPF is attached to an IRB number, the information pulls to submissions page and you can check the current status
Visit the site below and look for CRMS Training
- from UNC Healthcare
What is a 98 account number and why do you need one:
What should coordinators know about Hospital Systems?
966-7603 phone, firstname.lastname@example.org
Administrator, Division of Endocrinology
Study Start Up/Initial Payment
Document and Drug Maintenance
Protocol and Visit Schedule
Non-Refundable Start Up fee
Research Fee Schedule
Effort Based Procedures
PI and CRC Time
RFA-Request for Application
Salary Cap/Cost Share
Medicare’s Clinical Trial Policy applies to (only):
May We Bill Medicare?
(Note, some studies will not “qualify” for coverage – if in doubt, the Medicare contractor should be consulted. If, for instance, non-covered device is used, associated services will not be covered)
“Deemed” qualifying studies (possess seven of ten criteria): trials funded by NIH, CDC, AHRQ, CMS, DOD, VA, incl. centers and cooperative groups; investigational new drug (IND) application reviewed by the FDA; drug trials exempt from having an IND (under 21 CFR 312.2(b)(1); then
Other billing considerations:
Remember, there are consequences for improper billing of Medicare!
We look forward to seeing you at future training opportunities!
For a copy of this presentation& additional helpful information
TRACS.UNC.edU / RESEARCH CENTRAL