1. Industry Sponsored Clinical Trials and Program Development Accounts Jerry Grabner Sr. Financial Analyst Sponsored Projects Administration (SPA)

2. Audience This course is intended for :  Division Managers  Department Administrators  Clinical Research Coordinators  Department Fiscal managers  Department Effort Coordinators  Anyone who wants to know more about the financial management of Industry Sponsored Clinical Trials

3. Course Content The areas covered in this course are:  Terms Used in Clinical Trials  Clinical Trials I (Pre-Award): A Quick Review  Clinical Trials II (Post-Award)  Program Development Accounts

4. Clinical Trial (Definition) Study Phases Protocol Terms Used in Clinical Trials

5. Definition of a Clinical Trial at OHSU  The study of a drug, device or therapy using human subjects Mission Code 54 in OGA Terms Used in Clinical Trials

6. Study Phases I - IV:  Clinical Trials are conducted in phases  Each phase has a different purpose to help scientists answer different questions (See handout for more information regarding each phase.)

7. Terms Used in Clinical Trials Protocol: A study plan on which a Clinical Trial is based.  Identifies the specific research questions to be answered  Describes the parameters of the study  Safeguard the health of the participants

8. Clinical Trials I (Pre-Award) Industry Sponsored Clinical Trials The course is available at: http://www.ohsu.edu/research/rda/spa/ct1_2pep.shtml

9. Clinical Trials I (Pre-Award) This course follows the financial life cycle of a clinical trial up to clinical trial implementation:  Policies and guidance  Budget preparation  Payment schedules  Set-up of Accounts  Third party payer approvals

10. Clinical Trials I (Pre-Award) Clinical Trials Office (CTO - Pre-study)  For Industry Sponsored Studies, CTO - Pre-study can do your budget, IRB submission, and account requests for you. Fee paid by the sponsor –Median budget 19% higher –IRB approvals 22% faster –(excludes cancer trials)  Contact Bridget Adams, CTO – Pre-study Manager http://www.ohsu.edu/research/crp/cto/index.shtml

11. Clinical Trials I (Pre-Award) Clinical Trials Office (CTO – Contracts)  Receives Sponsor’s proposed Agreement  Initiates Jellyfish Tracking PPQ number assigned –http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=132:1:14251149068476920202http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=132:1:14251149068476920202  Negotiates the Agreement  Executes the Agreement  Sends the Agreement to Sponsored Projects Administration (SPA) to be setup in OGA

12. Clinical Trials II (Post-Award) Industry Sponsored Clinical Trials

13. Industry Sponsored Clinical Trials (Post-Award Administration) Topics we will be covering:  Account Management Responsibilities  Account Set-up  Budgets (Post-award)  Cash Management  End Dates  Invoicing  Expenses  Deficits  Closeouts  Post-closing (PDA’s and DRA’s)

14. Account Management Responsibilities (Financial Perspective) Department (PI & Staff) Clinical Trials Office (CTO - Contacting) Sponsored Projects Administration (SPA)

15. Department (PI & Staff)  Develop budgets that accurately reflect the true cost of performing the work on the project  Conduct the study per the protocol and contract  Manage the financial aspects of the project - - (Review expenses and income on a regular basis)  Close the financial aspects of the study and determine the disposition of the residual balance Account Management Responsibilities (Financial Perspective)

16. Clinical Trials Office (CTO – Contracts)  Receives Sponsor’s proposed Agreement  Initiates Jellyfish Tracking PPQ number assigned –http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=132:1:14251149068476920202http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=132:1:14251149068476920202  Negotiates the Agreement  Executes the Agreement  Sends the Agreement to Sponsored Projects Administration (SPA) to be setup in OGA Account Management Responsibilities (Financial Perspective)

17. Sponsored Projects Administration (SPA)  Setup award / project in OGA  Provide expertise and guidance in project management  Provide mechanism for review of expenditures  Provide mechanism to certify the termination of the financial aspects of a project  Invoice for Setup costs / Initial and ongoing IRB Fees

18. Turn around time for setup The flow - - Setup Review & Analysis  SPA Intake – logging, review for documents  SFA – for analysis, review, budget/invoice figures  Setup Specialist – input to OGA, scan and attach agreement, file setup, send the Notice  SFA – for review of OGA setup  SPA Award Revenue – Invoicing Setup Process

19. Award/Project Relationship Start Dates End Dates Close Dates

20. Notice of OGA Account Setup/Revision (The Notice) Notification to Department — (The Notice) Notice of OGA Account Setup/Revision  Documents how the study has been setup in OGA  Provides information needed to begin spending  Notify the SPA Account Setup Team if there are any errors SPA Account Setup: spasetup@ohsu.edu spasetup@ohsu.edu

21. Sent by email to people designated at the Award & Project level Roles:  Principal Investigator  Fiscal Manager / Administrator  Study Coordinator (CRC)  Pre-Award Contact (CTO / RGC)  SPA Analyst  IRB Notice of OGA Account Setup/Revision (The Notice)

22. Review the (The Notice) carefully Notify SPA if there are any errors Contact for Questions regarding setup: - Email to: SPA Account Setup: spasetup@ohsu.eduspasetup@ohsu.edu Notice of OGA Account Setup/Revision (The Notice)

23. Notices can be printed by the Department ZPA - OGA Account Setup (The Notice) ZPA - Project Setup Validation ZGMS - Award Setup Validation Agreements are attached to the project Can be printed by the Departments Notice of OGA Account Setup/Revision (The Notice)

24. IRB & Setup Cost Invoicing IRB and Setup Cost Invoicing by SPA  Prepare invoice to Sponsor / CRO for the initial IRB review and setup costs  Invoice sent to dept for two days for concurrence  Contact for IRB and setup cost invoices: - Email to: SPA Award Revenue Mailbox: spacash@ohsu.eduspacash@ohsu.edu

25. End Date Extensions Policy & Procedure  http://www.ohsu.edu/research/rda/spa/spapolicies.shtml http://www.ohsu.edu/research/rda/spa/spapolicies.shtml Current IRB Approval Required SPA Review/Extension Process  Signature Date  Contract  Terminated or Lapsed IRB Approval

26. Budgets Oracle Grants Accounting (OGA)  Budget = Cash Budget Controls Budget Categories  Direct Costs  Facilities & Administrative (F&A) Costs

27. Budgets Budget Categories (Cont)  Facilities & Administrative Costs Assessment to Sponsor = 25% Applied to Project through OGA –20% University –5% Department (Department Assessment) (Stays in the project if Department chooses not to take it)

28. Cash Management (Award Revenue) What Initiates Payments?  CRF’s  Milestones  Specific Dates  Other Automatic payments  Invoices issued  Note: Check your contract for specifics

29. Cash Management (Award Revenue) Application of Cash  The Process  Notification of Cash Applied  Specific Items: IRB (Initial) & Setup Fees Payments DC/F&A Split (80%/20%) Reimbursements

30. Application of Cash  Specific Items (Cont): Reimbursements –Processing & Notification –100% DC to Expenditure Type being reimbursed »F&A automatically adjusts (reduces) at the F&A Rate »If no expenses, or reimbursement is greater than expenses, then applied as cash with DC/F&A split Cash Management (Award Revenue)

31. Invoicing SPA  IRB Initial Review and On-going IRB Activities  Setup Fees Departments  Per contract for study payments  Reimbursable items  Other items identified in the contract Invoice template and sample on SPA website: http://www.ohsu.edu/research/rda/spa/spapolicies.shtml http://www.ohsu.edu/research/rda/spa/spapolicies.shtml

32. Invoicing Invoicing and Follow-up Responsibilities:  Industry Sponsored Clinical Trial Invoicing Process Summary (Invoice Summary Matrix)

33. Expenses General Guidelines:  Not as restrictive as Federal or Foundation Accounts  There may be items excluded by the contract  Subject to OHSU’s general guidelines for expenditures

34. Sources of Direct Cost Expenses in OGA  Internal Billing System (Service Centers) Examples: Hospital Charges, Telecom, Pharmacy, etc.  Disbursement & Check Requests; Purchase Orders, Vendor Invoices, etc. (Accounts Payable)  Labor Distribution - Payroll System (Payroll & Travel)  Journal / Adjustment Entries Foundation Transfer Form (Departments & SPA) University Adjustment Forms (Departments & SPA) Pre-Approved Batches (SPA) Expenses

35. F&A (Facilities and Administration)  Rate = 20% applied to Direct Cost Expenses Automatically assessed by OGA Adjustments can be made by SPA Exclusions from F&A  IRB Fees (OHSU IRB)  Pharmacy Setup Fees  Department Assessments (5%) Expenses

36. Review Expenses Monthly  Industrial Account Reports (IBS)  OGA Reports (SPA) Review for:  Expenses that should not be there  Incorrect Amounts  Omitted Expenses Expense Review & Corrections

37. Review Guidelines  Accurate (In the correct amount)  Allowable (OHSU’s and Sponsor’s Guidelines)  Appropriate (Applicable to study / Fulfills Research Mission)  Summary: Is it Reasonable for this study? Expense Review & Corrections

38. Correct Errors at their Source  IBS - - (The Service Center initiating the expense) Includes: Hospital Charges, Telecom, Pharmacy, etc  Disbursement & Check Requests; Purchase Orders, Vendor Invoices, etc. - - (Accounts Payable)  University Adjustment Forms - - (Departments & SPA)  Payroll and Travel - - (Labor Distribution System)  SPA’s Pre-Approved Batches - - (SPA) Expense Review & Corrections

39. Correct Errors at their Source  IBS - - (The Service Center initiating the expense) Includes: Hospital Charges, Telecom, Pharmacy, etc  Disbursement & Check Requests; Purchase Orders, Vendor Invoices, etc. - - (Accounts Payable)  University Adjustment Forms - - (Departments & SPA)  Payroll and Travel - - (Labor Distribution System)  SPA’s Pre-Approved Batches - - (SPA) Expense Review & Corrections

40. Finding Details of the Transaction  Transaction details for charges can be obtained through: General Ledger Inquiry OHSU (OHSU GL) Foundation Acct Inquiry (Foundation GL) OGA Inquiry Expense Review & Corrections

41. Tips for Industrial Account Related Errors  Contact Patient Billing Services if: An Item Has Been Ordered Incorrectly An Expense is Missing  Contact the Specific Service Center if: An Item is Ordered Correctly but Has Been Entered or Billed Incorrectly Expense Review & Corrections

42. Deficits Deficit spending permitted on CT’s Deficits are the responsibility of department $15K - Formal Process begins  Review  Notification  Department response  Resolution

43. Deficits Summary:  It is understood that Clinical Trials may run a deficit balance  Deficits are not taken lightly  A procedure is in place to assist Departments in deficit resolution  The department is responsible for deficit balances  A quick response and action are essential  SPA has authority to move deficits to department accounts if not resolved in a timely manner

44. Closeout Two Elements to the Closeout  The Science - Termination w/ IRB  The Financial – Closing w/ SPA Prior to Financial Closeout Activities Balance Transfer Form Process Special Situations

45. Closeout Prior to Financial Closeout Activities - -  Department – review account to verify that there are no: Encumbrances –Open PO’s –Outstanding Invoices payable Outstanding payments to be received Payroll posting to the project or adjustments pending Recurring payments that have not been stopped Industrial Accounts that have not been cleared Petty Cash Account that have not been closed

46. Closeout Two Elements to the Closeout  The Science - Termination w/ IRB  The Financial – Closing w/ SPA Prior to Financial Closeout Activities Balance Transfer Form Process Special Situations

47. Program Development Accounts Jerry Grabner Sr. Financial Analyst Sponsored Projects Administration (SPA)

48. Program Development Accounts  What are they?  Who’s responsible for the management of a PDA?  For what can they be used?  What restrictions are there on the use of the funds?  What needs to be done to have a PDA setup?  What are the guidelines or parameters for a PDA?  How do the funds get from the ended project into the PDA?  What is the F&A rate on a PDA?  Why is there an F&A expense on the PDA?

49. Program Development Accounts  What are they? Unrestricted funds from the residual balances of Fixed Price Agreements – Industry Sponsored Clinical Trials

50. Program Development Accounts  Who’s responsible for the management of a PDA? The Department –The PI –Department Fiscal Manager

51. Program Development Accounts  For what can they be used? To further the research mission of OHSU. Expenses must be allowable per OHSU guidelines. –Examples: Travel, Conferences, Equipment, Unallowable Expenses and Deficits from other projects, A source for funding new research projects (DRA’s).

52. Program Development Accounts  What restrictions are there on the use of the funds? No human or animal related expenses. Not permitted to have a deficit balance.

53. Program Development Accounts  What needs to be done to have a PDA setup? Two Forms: –Program Development Account (PDA) Request Form –Balance Transfer Form –http://www.ohsu.edu/research/rda/forms.shtml#fmhttp://www.ohsu.edu/research/rda/forms.shtml#fm

54. Program Development Accounts  What are the guidelines or parameters for a PDA? One Award per Institutional Unit / Department / Division Multiple projects by PI/Group of PI’s (IU / Dept / Div) New installment for each transfer to the PDA Indefinite End Date (6/30/2025) Award Budgets = total amount moved to the PDA Project Budgets = amount designated for each project Department responsible for tracking spending on each PDA

55. Program Development Accounts  How do the funds get from the ended project into the PDA? Summary: Through a series of budget, expense and revenue adjustments Internal SPA process is much more complicated

56. Program Development Accounts  What is the F&A rate on a PDA? Zero % on direct cost expenses

57. Program Development Accounts  Why is there an F&A expense on the PDA? F&A tracking tool for funds transferred to a PDA –To assure the Department gets “credit” for F&A earned in the distribution of F&A »Process began 7/01/03 »Tracked through a different process 4/01/01 – 6/30/03

58. Program Development Accounts Guidelines Guidelines include:  Terminology  Definitions PDA’s; DRA’s  Responsibilities PI/Department; SPA  Closing PDA’s

59. Program Development Accounts Guidelines Guidelines (continued):  Guidelines identify and delineate between: Undefined Research Program Account (PDA) –General types of research expenses Defined Research Account (DRA) –Research studies with a specific scope of work or involve human or animal subjects –Funded from PDA’s

60. Program Development Accounts Guidelines Guidelines (continued):  Transfers of PDA funds Between PDA’s From PDA’s to PDA funded Defined Research Projects (DRA’s) From OHSU To OHSU

61. Program Development Accounts Guidelines Guidelines (continued):  Guidelines, Helps and Forms SPA Program Development Account Guidelines http://www.ohsu.edu/research/rda/spa/docs/pdguidelines.pdf http://www.ohsu.edu/research/rda/spa/docs/pdguidelines.pdf Balance Transfer Form http://www.ohsu.edu/research/rda/spa/docs/fpastatus.pdf http://www.ohsu.edu/research/rda/spa/docs/fpastatus.pdf SPA Program Development Request Form http://www.ohsu.edu/research/rda/spa/docs/spapdarequest.doc http://www.ohsu.edu/research/rda/spa/docs/spapdarequest.doc Defined Research Account Request Form http://www.ohsu.edu/research/rda/forms.shtml#fm http://www.ohsu.edu/research/rda/forms.shtml#fm PDA / DRA Comparison Matrix http://www.ohsu.edu/research/rda/spa/docs/dracompmatrix.pdf http://www.ohsu.edu/research/rda/spa/docs/dracompmatrix.pdf

62. Any Questions on PDA’s or DRA’s? SPA Analyst for PDA’s & DRA’s Hope Asana Phone: 503-494-4573 Mail Code: L106SPA

63. Miscellaneous Helpful Items Communication Tips  Emails Include the OGA Project # in the subject line Respond on the chain of previous email  Phone Messages Include the OGA Project # Brief question or statement of issue Phone number for return call

64. Miscellaneous Helpful Items How to contact me?  Email: Jerry Grabner - - grabnerj@ohsu.edu grabnerj@ohsu.edu  Phone: 503-494-6827  Fax: 503-494-1191  Campus Mail: L106SPA  Location: 0690 SW Bancroft St.

65. Miscellaneous Helpful Items Key Course Handouts:  Invoicing Matrix  Deficit Matrix  PDA Quick Reference Sheet  PDA / DRA Comparison Matrix  Department Assessment Guideline  OGA Reports

66. Questions?