Industry Sponsored Clinical Trials and Program Development Accounts Jerry Grabner Sr. Financial...

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

Clinical Trial (Definition)

Study Phases

Protocol


Definition of a Clinical Trial at OHSUThe study of a drug, device or therapy using

human subjects• Mission Code 54 in OGA



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.)


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 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 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

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

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)


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

Setup Process

Award/Project Relationship

Start Dates

End Dates

Close Dates

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


(The Notice)

Review the (The Notice) carefullyNotify SPA if there are any errorsContact for Questions regarding setup:

- Email to:

SPA Account Setup: [email protected]


(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


(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


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


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?


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)


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)


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


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


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


Jerry Grabner

Sr. Financial Analyst



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?


What are they?• Unrestricted funds from the residual balances

of Fixed Price Agreements – Industry Sponsored Clinical Trials


Who’s responsible for the management of a PDA?

• The Department– The PI– Department Fiscal Manager


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).


What restrictions are there on the use of the funds?

• No human or animal related expenses.• Not permitted to have a deficit balance.


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


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


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


What is the F&A rate on a PDA?• Zero % on direct cost expenses


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


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



Transfers of PDA funds• Between PDA’s• From PDA’s to PDA funded Defined Research

Projects (DRA’s)• From OHSU• To OHSU



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


How to contact me?

Email: Jerry Grabner - - [email protected]

Phone: 503-494-6827Fax: 503-494-1191Campus Mail: L106SPALocation: 0690 SW Bancroft St.


Key Course Handouts:

Invoicing MatrixDeficit MatrixPDA Quick Reference SheetPDA / DRA Comparison MatrixDepartment Assessment GuidelineOGA Reports

Questions?

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