Industry Sponsored Clinical Trials and Program Development Accounts Jerry Grabner Sr. Financial Analyst Sponsored Projects Administration (SPA)
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Transcript Industry Sponsored Clinical Trials and Program Development Accounts Jerry Grabner Sr. Financial Analyst Sponsored Projects Administration (SPA)
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: [email protected]
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: [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
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 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 - - [email protected]
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?