Research Subject Registration
& Grant Charges
Clinical Research Education Series
August 29th, 2006
Marta Sears
1
Overview
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Form Review
Discuss SOC (Standard of Care)
Tips
Professional Fees
Summarize Primary Changes
How to Set Up the form
Informing & Scheduling the Subject
The Bill
Sample Packet Review
2
What ?
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Replacement Clarian Form
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Charges
and
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Registration
Related Process
3
Why ?
Process Improvement
 ↓ Billing Errors
 ↓ Uncollected $
 Track
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# subjects
# studies
room use
4
How to Implement ?
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Committee:
Team, Team Managers, Project Directors
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Pilot:
6/1/06 to 8/31/06
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Initiation:
9/1/06
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“The Form”
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Current Version
“GRANT CHARGE FORM”
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New Version, eff 9/1/06
“RESEARCH REGISTRATION /
GRANT CHARGE FORM”
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7
Abbreviated Registration
Box #1
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Study Contacts
Box #2
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Brief ~or~ Full Registration
Box #3
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“Routine Services”
~or~ Standard of Care (SOC)
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A service that would be provided to the patient
whether or not they were participating in a
clinical trial.
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The service is medially indicated for the diagnosis
~or~ for a patient receiving the specific drug or
treatment.
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Example:
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wlkly PT/PTT for coumadin titrations
Intercurrent unrelated medical event, ie: UTI
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NOT a routine SOC research services
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Not routine SOC: Performed only because of clinical
trial participation
 Tests
 Procedures
 Visits
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Establish at time of budget process. Bill to sponsor
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Example:
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Protocol required Daily PT/PTT when wkly is the standard
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13
Study Identifiers / Account #’s
Box #4
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Charge descriptions
Box #5
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Box # 5
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Note
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List Grant Account charges ONLY
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Do NOT list NON-Grant Account Charges
Pre-Fill box columns…..for a specific study
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Where do I find service codes & charges???
Is the charge going to match our budget??
“√”
all items……for a specific visit date
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Where are Service Codes &
Charges???
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Abbreviated Price List
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Small sample
Missing additional associated charges
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Requiring contact with Clarian service area
Study Manager, down the road, to include pricing
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Contact List (service area)
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Verify charges & Associated charges w/ Clarian service area
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Obtain quote via email (written)
ie: the medication charge in addition to a procedure charge
Maintained by UH AOC, Riley not listed
Prior FIS / EPIC documents
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May list procedure svc code & charges
Abbrev Price List & Contact List: Will be kept on SOM
OCR web site
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Will Charge Match our Budget??
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IDEALLY
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Service codes & Charges are identified
at the point in time that the study budget is built
Verify Charge w/ Clarian PFS
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35% discount
Verify service area Charge matches PFS Svc Code Charge
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Clarian Charges do ↑
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How? List quoted charge on “the form” & submit to PFS
However, charge will not continue to be seen on the form
Sponsor budget should allow for ↑ expenses
PFS: Patient Financial Service, 962-8090
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Professional Fees
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“The form” is a Clarian form
However, the form may be utilized for professional
fees, ie: Radiology Associates, etc. if acceptable w/
the specific professional practice area
The coordinator or department support person will
contact the professional area to determine / negotiate
charges & to verify what form will be used
Consideration should be made if the professional is
already compensated through the grant account, ie:
the PI
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Primary Changes in the Process
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Clarian now tracks subject visits, even if there are no
procedures or Clarian staff utilized
Check Box #5 “Exam/Consult Room” …. No Charge
Now submit expected grant charges up front to
Camille, improving communication & ↓’ing chance for
subject billing error
Now encouragement to submit form directly to each
service area or practice plan (ie: Radiology Associate)
to ↓ patient billing errors
Pilot program improved communication about
research between Clarian and IU, with other potential
committee’s to come
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Related Process
Refer to the “Research
Grant Process” document
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Set Up a Pre-Filled Form
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Contact Camille Gilliam at PFS w/ information for
Box #2,4,5
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May also include quotes to PFS for verification
May send via fax, email or phone call
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Send Camille the IRB approved DRA
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Camille will provide “the form” by email (Word Doc)
w/ the assigned Clarian Grant Account #
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Camille will also campus mail the form, along with
other information
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Camille Gilliam
Patient Financial Services
Email
Fax#
Phone#
cgilliam@clarian.org
962-0861
962-8090
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Informing the Subject
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Inform subject: Under what circumstances Full
Registration (obtaining insurance information) may occur
Inform subject: What expenses are paid or not paid by
the grant account
Inform subject: What expenses may be the patient/3rd
party responsibility & if pre-certification is needed
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Consider standard of care expenses
Consider adverse events related to the study
Consider medical events not related to the study
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The Informed Consent should adequately describe
 The Informed Consent should be signed prior to study
related procedures
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Scheduling the Subject
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Schedule subject, including use of “the form”,
appropriate requisition, per Clarian service
area standards, ie:
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Phlebotomy:
ECG:
Neuro MD visit:
PFT Lab:
GI:
MDC:
Walk In
Walk In
Outlook, Full Registration
Call in advance
Place on a list if CRC only
List if CRC only
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Pre-Filled subject specific Form
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Complete Box #1 & 3 for the specific subject
 At or Prior to the subject visit:
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Complete date of visit (top)
Check off applicable charges in Box #5
Submit copy directly to the service area or
professional area, ie:
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1 form to UH Radiology
1 form faxed to Radiology Associates (Rita Bridge)
Emailing the form w/ subject identifiers is not secure
Service area will submit the form to Camille
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Camille will call if charge is unclear
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The Bill
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Subject receives bill
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If Grant Acct, then process
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Assess if Grant Acct or pt/3rd Party responsibility
FIS (Financial Information Services) expense
itemization for verification & approval.
If not correct put on Hold, notify accounting
If non-research staff are utilized = Charge
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ie: Difficult stick. Request Clarian staff to draw =
charge
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Clinical Trials Charge Forms
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Clarian
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Wishard
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Complete “Research Study Initiation Request Form” & send to Alice Roff at
Wishard. Contact Tina Noonan 278-5802. Use of over-ride number. New IU
SOM flat research rate of 125% of Medicare at Wishard
Practice Plan Encounter Forms
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“Research Registration / Grant Charge Form”, 35% discount, Camille Gilliam
962-8090
“Custom Lab Test Request”, research rates, contact Kim Weir 745-2775
Contact appropriate practice plan administrator
Contact
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Marcia Gonzales, Compliance Officer (278-4891) for questions, in addition to
seeking direction from service area administration (ie: UMDA, Clarian dept)
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Handouts
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Research Registration / Grant Charge Form
Illustrations / Samples
Research Grant Process
Flow Sheet
Clarian Grant Charge Form Procedure for PFS
Contact List
Abbreviated Clarian Charge Code
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