1. ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL MODULE 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

5. What is the UNC 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 Clinical Research Management System (CRMS)

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. PROCEDURESPROCEDURES

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

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. 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. Visit the site below and look for CRMS Training

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.edulbcowan@med.unc.edu Person on hospital side assigning 98#: Amelia Rountree @ 966-7603, ARountre@unch.unc.edu 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.eduarountre@unch.unc.edu Nancy Rose 966-4887, nrose@unch.unc.edunrose@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

51. 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. F&A Ensure correct University F&A rate is being applied

52. Invoiced Items Start Up Fee Advertising Document Storage Rent Screen Fails Adverse Events FDA/Sponsor Audits IRB Fee IRB Renewal IDS Dry Ice Protocol Amendment

53. Facilities and Administration Rate

55. Federally Funded Grants RFA-Request for Application All Federal Funded applications are linked to a RFA which details the requirements for the application. SF424 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.

56. 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

57. Financial Compliance

58. Effort Certification and Reporting Technology 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 worked 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 ecrt.unc.edu 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

59. MEDICARE COVERAGE ANALYSIS Jill Cunnup

60. Medicare’s Clinical Trial Policy applies to (only): Clinical research services provided to Medicare beneficiaries Specifically written for government-funded studies and drug studies Clinical Research Billing Compliance May We Bill Medicare?

61. 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 covered)

62. “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 some Remember, there are consequences for improper billing of Medicare!

63. 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 Visits PaymentExpenses

64. 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 skipped. 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.

65. 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.

66. 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.

67. WE LOOK FORWARD TO SEEING YOU AT FUTURE TRAINING OPPORTUNITIES!

68. PLEASE VISIT FOR A COPY OF THIS PRESENTATION & ADDITIONAL HELPFUL INFORMATION TRACS.UNC.EDU / RESEARCH CENTRAL