industry sponsored clinical trials and program development accounts jerry grabner sr. financial...
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Industry Sponsored Clinical Trials andProgram Development Accounts
Jerry Grabner
Sr. Financial Analyst
Sponsored Projects Administration (SPA)
Audience
This course is intended for :Division ManagersDepartment AdministratorsClinical Research CoordinatorsDepartment Fiscal managers Department Effort CoordinatorsAnyone who wants to know more about the
financial management of Industry Sponsored Clinical Trials
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
Definition of a Clinical Trial at OHSUThe study of a drug, device or therapy using
human subjects• Mission Code 54 in OGA
Terms Used in Clinical Trials
Terms Used in Clinical Trials
Study Phases I - IV:Clinical Trials are conducted in phasesEach phase has a different purpose to help
scientists answer different questions
(See handout for more information regarding each phase.)
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
Clinical Trials I (Pre-Award)Industry Sponsored Clinical Trials
The course is available at: http://www.ohsu.edu/research/rda/spa/ct1_2pep.shtml
Clinical Trials I (Pre-Award)
This course follows the financial life cycle of a clinical trial up to clinical trial implementation:Policies and guidanceBudget preparationPayment schedulesSet-up of AccountsThird party payer approvals
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
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=132:1:14251149068476920202
Negotiates the Agreement
Executes the Agreement
Sends the Agreement to Sponsored Projects Administration (SPA) to be setup in OGA
Industry Sponsored Clinical Trials
(Post-Award Administration)
Topics we will be covering:Account Management ResponsibilitiesAccount Set-upBudgets (Post-award)Cash ManagementEnd DatesInvoicingExpensesDeficitsCloseoutsPost-closing (PDA’s and DRA’s)
Account Management Responsibilities(Financial Perspective)
Department (PI & Staff)
Clinical Trials Office (CTO - Contacting)
Sponsored Projects Administration (SPA)
Department (PI & Staff)Develop budgets that accurately reflect the true cost
of performing the work on the projectConduct the study per the protocol and contractManage 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)
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=132:1:14251149068476920202
Negotiates the Agreement
Executes the Agreement
Sends the Agreement to Sponsored Projects Administration (SPA) to be setup in OGA
Account Management Responsibilities (Financial Perspective)
Account Management Responsibilities (Financial Perspective)
Sponsored Projects Administration (SPA)Setup award / project in OGAProvide expertise and guidance in project
managementProvide mechanism for review of expendituresProvide mechanism to certify the termination of the
financial aspects of a projectInvoice for Setup costs / Initial and ongoing IRB
Fees
Turn around time for setupThe flow - - Setup Review & Analysis
SPA Intake – logging, review for documentsSFA – for analysis, review, budget/invoice figures Setup Specialist – input to OGA, scan and attach
agreement, file setup, send the NoticeSFA – for review of OGA setupSPA Award Revenue – Invoicing
Setup Process
Notice of OGA Account Setup/Revision
(The Notice)
Notification to Department — (The Notice) Notice of OGA Account Setup/RevisionDocuments how the study has been setup in
OGAProvides information needed to begin spendingNotify the SPA Account Setup Team if there are
any errors
SPA Account Setup: [email protected]
Sent by email to people designated at the Award & Project level Roles:Principal InvestigatorFiscal Manager / AdministratorStudy Coordinator (CRC)Pre-Award Contact (CTO / RGC)SPA AnalystIRB
Notice of OGA Account Setup/Revision
(The Notice)
Review the (The Notice) carefullyNotify SPA if there are any errorsContact for Questions regarding setup:
- Email to:
SPA Account Setup: [email protected]
Notice of OGA Account Setup/Revision
(The Notice)
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)
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: [email protected]
End Date Extensions
Policy & Procedure http://www.ohsu.edu/research/rda/spa/spapolicies.shtml
Current IRB Approval RequiredSPA Review/Extension Process
Signature DateContract Terminated or Lapsed IRB Approval
Budgets
Oracle Grants Accounting (OGA)Budget = Cash
Budget ControlsBudget Categories
Direct CostsFacilities & Administrative (F&A) Costs
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)
Cash Management(Award Revenue)
What Initiates Payments?CRF’sMilestonesSpecific Dates Other Automatic paymentsInvoices issued
Note: Check your contract for specifics
Cash Management(Award Revenue)
Application of CashThe ProcessNotification of Cash AppliedSpecific Items:
• IRB (Initial) & Setup Fees Payments• DC/F&A Split (80%/20%)• Reimbursements
Application of CashSpecific 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)
Invoicing
SPAIRB Initial Review and On-going IRB ActivitiesSetup Fees
DepartmentsPer contract for study paymentsReimbursable itemsOther items identified in the contract
Invoice template and sample on SPA website: http://www.ohsu.edu/research/rda/spa/spapolicies.shtml
Invoicing
Invoicing and Follow-up Responsibilities:
Industry Sponsored Clinical Trial Invoicing Process Summary (Invoice Summary Matrix)
Expenses
General Guidelines:Not as restrictive as Federal or Foundation
AccountsThere may be items excluded by the
contractSubject to OHSU’s general guidelines for
expenditures
Sources of Direct Cost Expenses in OGAInternal 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
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&AIRB Fees (OHSU IRB)Pharmacy Setup FeesDepartment Assessments (5%)
Expenses
Review Expenses MonthlyIndustrial Account Reports (IBS)OGA Reports (SPA)
Review for:Expenses that should not be thereIncorrect AmountsOmitted Expenses
Expense Review & Corrections
Review GuidelinesAccurate (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
Correct Errors at their SourceIBS - - (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
Correct Errors at their SourceIBS - - (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
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
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
Deficits
Deficit spending permitted on CT’sDeficits are the responsibility of
department$15K - Formal Process begins
Review Notification Department response Resolution
Deficits
Summary:It is understood that Clinical Trials may run a deficit
balanceDeficits are not taken lightlyA procedure is in place to assist Departments in
deficit resolutionThe department is responsible for deficit balancesA quick response and action are essentialSPA has authority to move deficits to department
accounts if not resolved in a timely manner
Closeout
Two Elements to the CloseoutThe Science - Termination w/ IRBThe Financial – Closing w/ SPA
Prior to Financial Closeout ActivitiesBalance Transfer FormProcessSpecial Situations
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
Closeout
Two Elements to the CloseoutThe Science - Termination w/ IRBThe Financial – Closing w/ SPA
Prior to Financial Closeout ActivitiesBalance Transfer Form ProcessSpecial Situations
Program Development Accounts
Jerry Grabner
Sr. Financial Analyst
Sponsored Projects Administration (SPA)
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?
Program Development Accounts
What are they?• Unrestricted funds from the residual balances
of Fixed Price Agreements – Industry Sponsored Clinical Trials
Program Development Accounts
Who’s responsible for the management of a PDA?
• The Department– The PI– Department Fiscal Manager
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).
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.
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#fm
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
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
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
Program Development Accounts Guidelines
Guidelines include:
Terminology
Definitions • PDA’s; DRA’s
Responsibilities• PI/Department; SPA
Closing PDA’s
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
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
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• Balance Transfer Form
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• Defined Research Account Request Form
http://www.ohsu.edu/research/rda/forms.shtml#fm• PDA / DRA Comparison Matrix
http://www.ohsu.edu/research/rda/spa/docs/dracompmatrix.pdf
Any Questions on PDA’s or DRA’s?
SPA Analyst for PDA’s & DRA’s• Hope Asana
• Phone: 503-494-4573
• Mail Code: L106SPA
Miscellaneous Helpful Items
Communication TipsEmails
• 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
Miscellaneous Helpful Items
How to contact me?
Email: Jerry Grabner - - [email protected]
Phone: 503-494-6827Fax: 503-494-1191Campus Mail: L106SPALocation: 0690 SW Bancroft St.
Miscellaneous Helpful Items
Key Course Handouts:
Invoicing MatrixDeficit MatrixPDA Quick Reference SheetPDA / DRA Comparison MatrixDepartment Assessment GuidelineOGA Reports