Orientation for New Clinical Research PERSONNEL Module 4

1. Orientation for New Clinical Research PERSONNELModule 4 Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research Professionals

2. 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

3. Overview of the Clinical Research Management System (CRMS) Ed Finerty, NC TraCS Institute Laura Cowan, NC TraCS Institute

4. CRMS.UNC.EDU

5. 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

6. What is the UNC CRMS? 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 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.

8. Submissions to the Office of Clinical Trials (OCT)

9. CRMS pre-populates all RRF information that you have already entered • Email notifications to the submitter and PI when the OCT status changes

11. 98 Account Submission &Using the Research Fee Schedule

12. PROCEDURES

15. Submitting your 98 Account request

16. 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.

17. Submissions toInvestigational Drug Services (IDS)

18. CRMS electronic IDS submissions do not require PI signature authorization CRMS Electronic 1572, protocol, and investigator brochure uploading You can request a pharmacist online through CRMS Electronic Protocol Intensity Worksheet New CRMS Medication Wizard

20. Budget Development

21. SCHEDULE OF EVENTS Fill all visits or procedures by cohort from one screen

22. BUDGET SUMMARY

23. PER VISIT COMPARISON

24. FEASIBILITY ANALYSIS

25. Other CRMS tools: • RAMSeS Submission Tracking • IRB List Organization • Schedule of Events Building • Recruitment Needs Analysis • Study Subject Advertising

26. Group by Coordinator or PI Export to Excel Sort by IRB expiration date

27. If an eIPF is attached to an IRB number, the information pulls to submissions page and you can check the current status

28. RESEARCHSTUDIES.UNC.EDU

30. TRACS.UNC.edU / RESEARCH CENTRAL

31. Upcoming Training: Visit the site below and look for CRMS Training • http://tracs.unc.edu/events-other-training/calendar/calendar.html • Please contact Ed Finerty @ 843-2861 if you have any questions or recommendations about the system.

32. Hospital 98 accounts and research billing Mary-Ann Minsley Amelia Rountree Nancy Rose - from UNC Healthcare

33. 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.

34. 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.

35. 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.

36. 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 • The In-patient hospital room Research 98 Account Request (for bed only) • 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)

37. 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.

38. Who to Contact for 98# Help • Contact people for questions or help • CRMS for assistance with 98# submission process • Laura Cowan @ 843-0726, lbcowan@med.unc.edu • Person on hospital side assigning 98#: • Amelia Rountree @ 966-7603, ARountre@unch.unc.edu

39. 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.

40. 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 account

41. 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.

42. Hospital Systems that use 98 number • G.E. • PIDX • 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 you. • The study coordinator should not feel as if they have to use the system and order the test themselves.

43. 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 / subject. • 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

44. 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 denied.

45. 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 arountre@unch.unc.edu • Send copy of bill, identify research study and 98 number to be charged, etc. • Incorrect billing can be corrected

46. Contact Information For questions: • UNC Hospitals Patient Account Services: Amelia Rountree 966-7603 phone, arountre@unch.unc.edu Nancy Rose 966-4887, nrose@unch.unc.edu • ISD Helpdesk (for linking 98# to patients) 966-5647

47. Budgeting and accounting of research Funds Jillyan Cunnup Administrator, Division of Endocrinology

48. The Financial Struggle

49. 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

50. 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