Module 4 - Network for Clinical Research Professionals

• 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
• Module 2:
Study Implementation, Documentation, and GCPs
• Module 3:
Contracting, COI, and Hospital Administrative Elements
• Module 4:
Clinical Trial Management, Budgeting, Hospital and
Research Accounting, & Medicare Coverage Analysis
Ed Finerty, NC TraCS Institute
Laura Cowan, NC TraCS Institute
What is the UNC CRMS?
Clinical Research Management System (CRMS)
A set of tools to help clinical research teams
• A web based program to help you with study management
• Budget builder linked to the Research Fee Schedule
• Single dashboard helps you monitor the pre-study process
• Online submissions to campus offices
• Incorporates data from several campus offices
• Main goal is to make research management more efficient and
easier for research staff
What is the UNC CRMS?
A place to test out planned studies
• Makes it easy to know what it will cost to run
your study and how a sponsor’s offer compares
to your real costs.
A UNC built application
• Developed with input from research teams and campus offices
• Linked to UNC systems and processes ( Thanks, ORIS!)
• Capabilities will grow to include the whole study life cycle
• An evolving collaboration between UNC research staff and
administrative offices
Submissions to the
Office of Clinical Trials (OCT)
• CRMS pre-populates all RRF information that
you have already entered
• Email notifications to the submitter and PI
when the OCT status changes
98 Account Submission &
Using the Research Fee Schedule
Submitting your 98 Account request
• PI certification is required.
• The CRMS submitter and the PI will receive an email
when the 98 account number has been assigned.
• Fee codes will be included automatically on your
submission form from your study record.
Submissions to
Investigational Drug Services (IDS)
• CRMS electronic IDS submissions do not require PI
signature authorization
• CRMS Electronic 1572, protocol, and investigator brochure
• You can request a pharmacist online through CRMS
• Electronic Protocol Intensity Worksheet
• New CRMS Medication Wizard
Budget Development
Fill all visits or procedures by
cohort from one screen
Other CRMS tools:
RAMSeS Submission Tracking
IRB List Organization
Schedule of Events Building
Recruitment Needs Analysis
Study Subject Advertising
Group by
or PI
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
Please contact Ed Finerty @
843-2861 if you have any
questions or recommendations
about the system.
Mary-Ann Minsley
Amelia Rountree
Nancy Rose
- from UNC Healthcare
Why do you need a 98 number?
What is a 98 account number and why do you need one:
• It allows researchers to bill clinic visits or inpatient room
stays, laboratory tests, procedures, and pharmacy
charges ordered as part of research to an account tied to
the research study so a subject or their insurance won’t
be billed.
• A Research Account (98#) is assigned by the UNC
Hospitals Patient Account Services.
How is a 98 number assigned?
• Apply for 98# via CRMS
(explained in previous presentation)
• All fields on the Billing and Payment Service Agreement
(98# application) must be complete. The list of required
services (tests) MUST include all services covered under
the study
• 98# will be assigned within 7 days via CRMS.
New 98 account numbers are issued once a week.
Billing and Payment Service Agreement
• The start date used should be the date the grant/study will
begin screening research patients.
• The end date the grant/study is expected to end and the
account be discharged.
• An extension request can be filed in CRMS.
Once your account number is assigned, an option to
revise the termination date will become available.
Two types of 98 numbers
• When completing the submission to request the 98
account number, there are two options:
• The
new Research 98 Account request and
In-patient hospital room Research 98
Account Request (for bed only)
• The
• This option is only to be used if your study includes an
in-patient hospital room for research purposes (and
the research participant is not admitted to the hospital
for medical reasons at the time of the visit)
Do users of the CTRC need a 98#?
• Not necessarily. The CTRC bills all CTRC charges
directly to your FRS number (outpatient clinic visit, dietary
or DEXA scans).
• But, if you need additional services provided by the
hospital (research procedures or laboratory tests run by
McLendon Labs), you will need a 98 account number.
Who to Contact for 98# Help
• Contact people for questions or help
• CRMS for assistance with 98# submission process
• Laura Cowan @ 843-0726, [email protected]
• Person on hospital side assigning 98#:
• Amelia Rountree @ 966-7603,
[email protected]
How to use the 98 number
• Now you have a 98 number, what do you do with it?
• Use 98# when ordering tests, procedures, or to charge a hospital
clinic visit to the research account
• Research tests ordered with 98# should match those
submitted on 98 number application
• If a Study Coordinator knows what patients are going to
be participating in the study, the patients can be linked to
the 98# prior to the visits.
Using the 98 number at the Clinic
• Study coordinator should ask Check-in staff (receptionist) to
link the patient to the 98 # in G.E. when ordering research tests
or procedures (labs, x-rays)
• What to tell front desk staff: “I have a Research Patient”
• If the patient is in more than one study, all the 98 account #’s
will appear in G.E.
• Have 98 number with you (not just IRB number) and guide
and oversee the process of ordering the test/procedure
making sure the correct 98# is linked to this visit
• Don’t leave this to the patient/subject
• Also able to charge a clinic visit or inpatient room to a research
Combining Research and Standard of
Care Labs and Procedures
• Can both standard of care labs and research labs be
ordered at the same time?
• Yes!
• Order all tests at same time and enter the 98#
• Entire bill for the clinic visit or day will be sent back to
study team to reconcile which tests belong to research
and which billed to insurance.
Hospital Systems that use 98 number
• G.E.
• A2K
• McLendon Lab System
• CT Vision
What should coordinators know about Hospital Systems?
• Recognize that others in clinic will be more trained and
able to use these systems and enter the 98 number for
• The study coordinator should not feel as if they have to
use the system and order the test themselves.
Reconciling Bills
• Linking the patient’s visit in G.E to a 98# creates a “bill
hold” which means the bill for the clinic visit and
tests/procedures performed are not sent to insurance /
• The bill hold data is reviewed by Hospital Patient
Accounts. The charges are reviewed and they work with
the Study Coordinators to reconcile the charges to be
billed to the 98 account.
• Important to reconcile bills in timely manner
Research Billing
• Invoices are sent monthly to the Study Coordinators to
reconcile for payment and or changes reported to Patient
Accounts in a timely manner.
• Payment is expected within 90 days. If payment is
delinquent requests for future 98 account numbers can be
Who to contact if subject gets a bill?
• Sometimes, despite all good intentions, a bill for research
tests accidently goes to subject or their insurance
• Reasons: error in entering 98# appropriately, user error, the visit
was not linked to the 98# .
• How to fix the bill:
• Main contact research bills:
• Amelia Rountree
• 966-7603 phone or email [email protected]
• Send copy of bill, identify research study and 98 number to be
charged, etc.
• Incorrect billing can be corrected
Contact Information
For questions:
• UNC Hospitals Patient Account Services:
Amelia Rountree
966-7603 phone, [email protected]
Nancy Rose
966-4887, [email protected]
• ISD Helpdesk (for linking 98# to patients)
Jillyan Cunnup
Administrator, Division of Endocrinology
The Financial Struggle
Clinical Trial Agreement
Study Start Up/Initial Payment
• When and what will be paid
Payment Cycle
• 30-60-90 days or MORE?
Withholding Amount
• 10% is trending industry standard
Final Payment
Document and Drug Maintenance
Budget Negotiations
Protocol and Visit Schedule
• Read and understand the time it will take to complete each visit
Non-Refundable Start Up fee
• Protocol Review
• IRB Paperwork
• IDS Paperwork
• 98 Account #
Research Fee Schedule
• The cost you will be charged for the actual procedure
• Does NOT include the time spent by the PI or the CRC
Effort Based Costs
Effort Based Procedures
• Informed Consent
• Physical Exams
• Vitals and History
• Drug Dispensing
PI and CRC Time
• Review of Labs, Scheduling of patients, recruitment of
patients monitor visits etc.
• Ensure correct University F&A rate is being applied
Invoiced Items
• Start Up Fee
• IRB Renewal
• Advertising
• Document Storage
• Dry Ice
• Rent
• Protocol Amendment
• Screen Fails
• Adverse Events
• FDA/Sponsor Audits
• IRB Fee
Facilities and Administration Rate
(10-mile radius)
Other Sponsored
Clinical Trials
Clinical Trials
Federally Funded Grants
RFA-Request for Application
• All Federal Funded applications are linked to a RFA which details the
requirements for the application.
• Common packet used for NIH submissions will include budget, bio
sketches, research plans, science of grant etc.
Salary Cap/Cost Share
• The current NIH Salary Cap is 179,700 anyone being paid from the grant
making over that amount must have a cost shared effort.
• Cost Sharing is the portion of the project that is contributed by the
University for example if you have a salary of 200,000 and are going to
spend 10% of your efforts (20,000) you are only allowed to charge the
grant for 10% of 179,700 (17,970) the difference must be charged to a
University account and paid for by the University. Using this example you
would need approval to cost share $2,030.
Modular Budget Vs. Detailed Budget
Modular Budget
• Used only in certain types of NIH applications provides a less detailed
budget with a maximum of 25,000 per module (250,000 per project)
• Does NOT list out salary and fringe benefit rates though the salary
cap does still apply
Detailed Budgets
• Effort must be shown in Calendar months not % of effort
• (10% effort =1.20 calendar months)
• Fringe Benefits
• Senior/Key Personnel
• Equipment
• Travel
• Publication
• Other costs related to project
• Maximum depends on the information in the RFA
Financial Compliance
Effort Certification and Reporting
• Effort is the portion of time spent on a given professional activity and
expressed as a percentage of the total 100% professional activity for which
an individual is employed by UNC.
• Important points:
• The government recognized that it is a “reasonable estimate”
• Total effort must equal 100%
• Effort is not based on a standard (e.g 40-hour) work week, instead based on whatever was
• 100% effort considers all professional activities related to the individual UNC appointment.
• Effort does not include outside activities (external consulting etc)
• Certifying Effort
• Effort is certified on a regular basis via
• All employees paid from sponsored activities are required to certify the effort spent
• Effort is calculated based on the information in the payroll system
• The investigational item or service itself, unless otherwise covered outside the clinical trial
Jill Cunnup
Clinical Research Billing Compliance
May We Bill Medicare?
Medicare’s Clinical Trial Policy applies to (only):
• Clinical research services provided to Medicare beneficiaries
• Specifically written for government-funded studies and drug
Things you need to ask:
• Is the scheduled service medically necessary for every
patient enrolled in the study?
• Is the item or service being used for clinical management of
the patient (and is therefor a “routine cost?”)
• Is the service normally covered by the payer?
(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
“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
• must fall within Medicare benefit category,
• must have therapeutic intent, and
• must enroll patients with diagnosed disease vs. healthy volunteers
Other billing considerations:
• Clinical Trial Agreement, Budget, Protocol and IRB-approved
Informed Consent form must be consistent.
• Medicare will not cover items or services provided “for free” to
Remember, there are consequences for improper billing of Medicare!
Accounting of Research Funds
• The tracking of research funds can make or break a research project. This is
often done by various people in the department but is crucial to success
Visit Tracking
• Industry Sponsored Trials-
• Log of completed, skipped or incomplete visits
• Track when data entry is completed per visit
• Invoice- Depending on payment terms some sponsors will pay
upon invoice for patient visits most do not however you should still
invoice on a regular basis to ensure that no visits are skipped.
• Keep a log of each visit completed by the subject and make note if
certain parts of the visit were not completed or if a visit was
• Federal Funded
• Tracking subject visits is equally important on a federal funded
studies. Depending on how the study is set you up may have
already received a set amount based on the number of patients. If
you fail to recruit or skip a visit you could end up paying back
money at the end of the grant.
Payment and Expenses
• Checks
• Ensure checks are sent in a timely manner based upon contract
• Always verify that the amount of money received matched the
amount of work completed.
• Expenses
• Track procedure, patient payments, salary, supplies as well as
other study related costs.
Closing of Account
• All money received?
• Make sure all visits, invoiced items,
• Always verify that the amount of money received matched the
amount of work completed as well as the amount on the contract.
• Expenses
• Verify IRB, IDS and other University expense have been paid.
Often with UNC bills are delayed and it is your responsibility to
check this before closing a study.
• Residual Funds
• If you have money leftover you will be allowed to transfer the funds
into a residual. Residual accounts are managed at the
Department/Division level. You will need to be aware of what the
policy is on spending and accountability. Federal funded grants will
require written communication and approval from the NIH for
carryover or no-cost extensions.
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