Industry Sponsored Clinical Trials
and
Program Development Accounts
Jerry Grabner
Sr. Financial Analyst
Sponsored Projects Administration (SPA)
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
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
Terms Used in
Clinical Trials

Clinical Trial (Definition)

Study Phases

Protocol
Terms Used in
Clinical Trials

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

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.)
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 guidance
Budget preparation
Payment schedules
Set-up of Accounts
Third 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
Clinical Trials II (Post-Award)
Industry Sponsored Clinical Trials
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)
Account Management
Responsibilities
(Financial Perspective)

Department (PI & Staff)

Clinical Trials Office (CTO - Contacting)

Sponsored Projects Administration (SPA)
Account Management
Responsibilities
(Financial Perspective)

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)

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)

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
Setup Process
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

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/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
Notice of OGA Account
Setup/Revision
(The Notice)

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)
Review the (The Notice) carefully
 Notify SPA if there are any errors
 Contact for Questions regarding setup:

- Email to:
SPA Account Setup: spasetup@ohsu.edu
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
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.edu
End Date Extensions

Policy & Procedure
 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
Budgets

Oracle Grants Accounting (OGA)
Budget = Cash
Budget Controls
 Budget Categories

Direct Costs
Facilities & 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’s
Milestones
Specific Dates
Other Automatic payments
Invoices issued
Note: Check your contract for specifics
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
Cash Management
(Award Revenue)

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
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
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
Accounts
There may be items excluded by the
contract
Subject to OHSU’s general guidelines for
expenditures
Expenses

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

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%)
Expense Review
& Corrections

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

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

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

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

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
Deficits
Deficit spending permitted on CT’s
 Deficits 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 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
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

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 Closeout
The Science - Termination w/ IRB
The Financial – Closing w/ SPA
Prior to Financial Closeout Activities
 Balance Transfer Form
 Process
 Special 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
What is the F&A rate on a PDA?
• Zero % on direct cost expenses
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 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
Miscellaneous
Helpful Items

How to contact me?
Email: Jerry Grabner - - grabnerj@ohsu.edu
Phone: 503-494-6827
Fax: 503-494-1191
Campus Mail: L106SPA
Location: 0690 SW Bancroft St.
Miscellaneous
Helpful Items

Key Course Handouts:
Invoicing Matrix
Deficit Matrix
PDA Quick Reference Sheet
PDA / DRA Comparison Matrix
Department Assessment Guideline
OGA Reports
Questions?