1. Brooke Marchetti, Project Administrator
Part 1 The Journey of a Clinical Trial Application through the Office of Sponsored Programs and Research Support (OSPARS)
Brooke Marchetti, Project Administrator

2. Journey Agenda
Familiarize the research community with OSPARS and our new processes
Explain the steps necessary to obtain approval for conducting research within UPMC facilities
Describe the process involved in the preliminary risk management review

3. About Us – Your Journey Guides
OSPARS is the central point of coordination for sponsored programs and clinical trials and is UPMC’s authorized representative for grants, contracts and other agreements from external sponsors
OSPARS facilitates sponsored programs and clinical trials by assisting in reviewing and endorsing proposals, negotiating agreements, accepting and authorizing awards, interpreting sponsor rules and guidelines, and providing post-award administration services

4. Choosing Destination Receipt of protocol synopsis from sponsor
Determination of study feasibility by study team
Confidentiality Disclosure Agreement (CDA) received and to be sent to OSPARS for negotiation
Choosing Destination
Travel Warning: Entry into sponsor’s web portals, or viewing of CD may have the same legal/confidentiality implications as signing paper CDA

5. Journey Preparation After CDA is finalized, you will receive
study packet from sponsor and need to do
the following:
Detailed feasibility determination in dept
Apply for departmental and scientific review
Seek guidance for CPT codes
Obtain pricing for procedures at destination hospitals/facilities for budget
Complete and/or obtain necessary documents for OSPARS review
Obtain unique identifier from your department

6. Journey Path – OSPARS or Pitt?

7. Travel Tips Request Pricing Budgeting IRB Preparation
Fiscal Review Preparation
CTRC Preparation
Device Study Preparation
Drug Study Preparation

8. Documents Needed for OSPARS Journey
Completed Clinical Trials Application
Completed Fiscal Review and Institutional Account Request Form
Departmental Risk Management Approval
Most Current Protocol Version
Investigator Brochure (IB)
Draft Clinical Trial Agreement (CTA) with Proposed Budget
Template Informed Consent Form (ICF)
Signed Cost Summary Sheet (CTRC study)

9. Details of Risk Management Tour
Review of ICF cost, subject injury and HIPPA language
Ensure ICF language in compliance with UPMC policies and Clinical Trial Agreement (CTA) or Master Agreement with Sponsor
Comments sent to study team within 5 business days of submission for concurrence with proposed changes to ICF
Travel Highlight: Thorough review and quick turnaround in response to requests/comments will prevent delay in Central IRB approval

10. IRB Review Tour Details
Submit revised ICF to sponsor for approval
When sponsor approves, submit to Central IRB with protocol, Investigator Brochure (IB), and all study documents that need IRB approval

11. Additional Tour Details
All investigators must complete research training modules (including Good Clinical Practice) in HS Connect and Conflict of Interest in MyHub
OSPARS negotiates contract language while department negotiates budget – process transparent to all parties
For Device Studies, OSPARS determines need for CMS coverage determination and works with study team to prepare packet for submission to CMS intermediary
For Drug Studies, OSPARS will notify IDS for review – study team will decide whether or not to use their services

12. CTRC Review Tour (Committee Review)
Complete online CRTC portal request
Schedule and complete budget meeting with CTRC
Obtain fully signed cost summary agreement form
After complete submission received in OSPARS, the CTRC is notified to review
Flow charts and additional information available on SharePoint

13. Tips to Making the Journey a Success
Meet with research administrator to prepare budget
Respond to OSPARS requests and comments within 5 business days
Forward IRB approval/Final budget to OSPARS as soon as received

14. Requirements for Journey Completion
IRB approval
Fiscal approval with Finalized Budget
Contract Execution – Site initiation visit can occur
CTRC approval (if applicable)
CMS approval (if applicable for device trial)
OSPARS approval

15. The Journey Continues (Continuing Review)
All changes to the study require review and approval from OSPARS
Continuing Oversight form – no longer required
Notification of changes to occur via to OSPARS inbox (Please follow appropriate format for subject line)
Body of must contain the name and phone number for contact person and information specific to the reason for submission, as outlined on our SharePoint site

16. Questions About Booking a Journey Through OSPARS
Please visit our Share Point:
Problems accessing Share Point, please

17. Part 2 On the Road Again… Costs and Billing in Clinical Trials
Presented by:
Office of Sponsored Program and Research Support (OSPARS)

18. Points of Interest on Road Trip
Need for Fiscal review and changes in processes for obtaining Institutional Accounts and Plan Codes
UPMC billing processes for Clinical Research studies/activities provided through hospital(s), clinics, UPMC facilities and Physician Services Division
Shared responsibilities in ensuring billing compliance in accordance to federal regulations and UPMC policy

19. Why is Fiscal Review Required?
To establish a risk management review plan for billing of clinical/research services within UPMC to comply with internal polices and external regulations

20. Does My Study Require Fiscal Review?
Will research subjects undergo any of the following that could potentially be billed by or occur within UPMC?
Diagnostic and/or interventional procedures
Administration of drugs
Insertion of medical devices
Collection of biological specimens
Laboratory assays
Any other patient care services
* Not fully inclusive list

21. Fiscal Review Process Updates and Reminders
New Combination Fiscal Review and Institutional Account Request form
Budget and proof of funding requirements (OSPARS and Pitt trials)
OSPARS and WPIC plan for
requesting IA #’s and
Program Codes

22. Research Fiscal Review Completion Tips
Schedule of events reconciles with protocol and ICF in OSIRIS Sections 2.5, 2.6, 2.7
Payment method reflects ICF, sponsor’s budget, and schedule of events
Indicate if one or both IA accounts (FIA/PIA) needed with procedures

23. Determination of Routine/Research Costs
Study team in conjunction with guidance from PI is providing draft outline of what they determine to be routine and research costs as relates to clinical trial
OSPARS will review to assure items listed and designated as routine/research are within requirements of National Coverage Determination
PI provides sign off on final determination and agreement via response

24. Medicare Qualifying Trial Determination
Study must meet 7 “desirable” characteristics of a clinical trial and 3 other criteria pertaining to study purpose, design and therapeutic intent (see handout)
Qualifying status determined by OSPARS in conjunction with PI input of therapeutic intent

25. Review of New Form
See Packet

26. How to Submit Fiscal/Institutional Account Request Form
Submit pricing request
Complete sections 1, 2 & 5 using section 3 for reference
For facility charges to
For professional/physician charges to
Submit form to OSPARS with study submission for Fiscal Review
Complete section 4

27. How Do I Obtain Pricing Quotes for Budgeting?
CPT codes are essential to ensure appropriate test is performed and billed (including CDM codes will expedite processing of request)
Request codes from Sponsor when research budget is received to lessen need to hunt for codes

28. Budgeting Tips
Budget for inflation (recommend 5% increase per year). CDM charges typically change January 1st and July 1st, however changes may occur at various times during the year
Facility research rates are based on Medicare cost report (RCC rates)
Remember to obtain rates for each individual facility and budget for professional fees associated with services provided at the hospital (Diagnostic Imaging, EKGs, Pathology)

29. Objective of Research Billing Processes
To ensure adequate processes are in place to bill clinical services to appropriate payor(s):
Third Party
Research Participant
Study (through Institutional Account or Plan Code)

30. What are IA’s, Plan Codes and Program Codes?
Institutional Accounts
An "FIA" is a facility institutional account (7777 xxxxx 9500) that is used to bill a clinical trial for the cost of performing the actual test at any UPMC facility
A "PIA" is a physician institutional account ( XXXX or XXXX), used by UPP to bill a clinical trial for the services of a physician to "read" or "interpret" the results of a test
Insurance Plan Codes
When an entire inpatient stay will be billed to clinical trial
When the inpatient charges will need to be audited BEFORE billing the payor
Program Codes
WPIC assigns # for study to allow treatment program to be entered into eRecord and to route charges to IA #’s

31. How Do I obtain my IA, Plan code?
Once OSPARS receives PI concurrence to fiscal comments and funding is confirmed, the following steps will occur:
Fiscal Reviewer will upload approved FRIAR form into OSIRIS (for Pitt studies)
Fiscal Reviewer will send approved FRIAR form in to study team, copying Lisa Hennigan
Study team will forward completed Program Code Request and approved FRIAR form to Lisa Hennigan
Lisa Hennigan will forward each form to the respective departments to have IA #’s and Program Codes created

32. Methods of Billing to IA’s
Program code is entered into eRecords
Lab Requisition is submitted for WPIC lab
Research Requisition is submitted for procedures performed outside of WPIC

33. Completing Research Requisition
It should accompany participant to all departments outside of WPIC
Form is used to ensure that outside departments properly bill to FIA/PIA
The contacts listed below should also receive the Research Requisition via
Patient Access
Ancillary Department (lab/imaging/cardiology)

34. Contact PSD/PBS when participant terminated or withdrawn from study
Final Reminders
Contact Patient Billing Customer Service at (800) and notify Institutional Billing via at the address below immediately if you are made aware of error in billing
Contact PSD/PBS when participant terminated or withdrawn from study
Contact OSPARS of overall study closure

35. Why is it Important to Follow Research Billing Processes?
Helps to meet Billing Compliance Guidelines/Requirements
Avoids for cause investigations/fines/penalties/payor participation restrictions
Prevents double billing (Example: billing insurance when the service already covered by the study/grant)
Prevents inappropriate billing (Example: third party payor billed for procedures that should have been billed to research account)
It’s the right thing to do

36. Wrap up
Questions?
Resources

37. Contact Information
Patient Business Services (PBS)
for Pricing Requests/IA issues
for Research Requisitions
Patient Business Customer Service
Physician Services Division (PSD)
for Pricing Requests/IA issues
for Research Requisitions
Michelle Mathier (412) or Karen Krapp (412)
Office of Sponsored Programs and Research Support (OSPARS)
(412)