Fund
Manager
Training
Clinical Trial Budgets 101
Clinical Trials
Clinical Trials Administration Office
David Geffen School of Medicine
May 17, 2016
Clinical Research & Clinical Trials
Clinical
Research
Clinical
Trials
Investigator
Initiated
Sponsor
Initiated
What is a Clinical Trial?
September 2006
At UCLA a “Clinical Trial” is defined as:
The controlled, clinical testing in human subjects of investigational
new drugs, devices, treatments, or diagnostics, or comparisons of
approved drugs, devices, treatments, or diagnostics, to assess their
safety, efficacy, benefits, costs, adverse reactions, and/or outcomes.
•
Such studies may be conducted under an industry-authored protocol or an
investigator-authored protocol.
•
Financial support for a clinical trial must be provided by a for-profit entity.
www.research.ucla.edu/ocga/memos/CT_Definition_Memo.pdf
What is NOT a Clinical Trial...
•
•
Retrospective chart review
Laboratory Research
•
•
(e.g. bench and basic science studies)
Federally funded clinical research
(NIH, DOD, VA, CMS, FDA grant studies)
Indirect Costs
Facilities & Administrative (F&A) costs
aka: “overhead” or “indirect costs”
• Industry-sponsored “Clinical Trials” (both, sponsor-authored &
investigator-authored):
• ALL COSTS subject to 26% indirect cost rate (with the
exception of mandatory IRB fees)
• Other Clinical Research conducted on campus (e.g. does NOT meet
UCLA definition of a “Clinical Trial”):
• Select costs (“Modified Total Direct Costs”) subject
to 54% indirect cost rate.
Sponsor-Initiated Clinical Trials
•
Industry Sponsor authors the protocol
• Industry Sponsor submits & maintains the IND/IDE
•IND = Drug Study (Investigational New Drug)
•IDE = Device Study (Investigational Device Exemption)
•
Industry Sponsor funds the study
•
Industry Sponsor assumes most liability
Investigator-Initiated Clinical Trials
•
Investigator authors the protocol
• Investigator usually submits/maintains the IND/IDE
• Industry Sponsor funds the study
•
University generally assumes most liability
Clinical Trial Set-up
Confidentiality Disclosure Agreement (CDA)
Submit to clinincaltrials@mednet.ucla.edu
Regulatory Packet and
Sponsor Budget/Contract Templates
IRB
Contract Office
Submit Min Docs to clinicaltrials@mednet.ucla.edu
Draft Budget (OnCore)
Includes: Coverage Analysis, CPT
Codes, Research Rates
Pre-Study Approvals
*IRB
Budget
Clinical Trials
Pre-Study Approvals
Research
Connect
Calendar
Build
Process
Contract &
Grant
*Additional
Approvals
* These Pre-Study Approvals are often managed by the PI or his/her study team.
Contract
Contract Updates
MINIMUM DOCUMENTS
REQUIRED TO INITIATE
CONTRACT REVIEW:




IRB Number (protocol and
ICF must be uploaded to
webIRB application)
EPASS (signed by PI)
UCLA Financial
Disclosure Forms
Draft Contract
SUBMIT TO
CLINICALTRIALS@MEDNET.UCL
A.EDU
Contract
Financial Disclosure Forms
700-U
700-U Addendum
State of California
University Form
Principal Investigator
PI & Key Personnel
Form:
State or local
Requirement:
Who
Discloses:
What to
Disclose:
Positive Disclosure
$500 +
Supplement
$10,000 +
CIRC Review
Note: CIRC must review & approve disclosures prior to contract execution.
Contract
Financial Disclosure Forms & Instructions
http://rpc.research.ucla.edu/RPC/Pages/COIForms.aspx
Contract
Financial Disclosure Process
• Disclosures are effective for a 12-month period:
• 700-U: report 12 months prior
•
700-U Addendum: report 12 months prior & future
• CIRC only meets once a month:
•
Contracts office must receive disclosure documents at least
three (3) business days prior to CIRC deadline.
•
Missed deadline may cause a significant delay (30 days min)
Why do we need financial disclosure forms?!
• It’s the law.
• University must manage financial interests.
• Positive disclosure(s) may affect Informed Consent Form language.
Contract
2016 CIRC Meeting Deadlines
Meeting Date
June 08, 2016
July 13, 2016
August 10, 2016
September 14, 2016
October 12, 2016
November 09, 2016
December 14, 2016
Submission Deadline
May 27, 2016
July 01, 2016
July 29, 2016
September 02, 2016
September 30, 2016
October 28, 2016
December 02, 2016
Question & Discussion
True or False: Financial Disclosure Forms are only
completed during study start-up.
FALSE
In the event a contract amendment replaces the
Principal Investigator, or increases funding for the
study, new disclosures will need to be submitted.
Question & Discussion
True or False: Financial Disclosure Forms should only
be completed for the Sponsor.
FALSE
In the event a Contract Research Organization (CRO)
is executing the agreement, disclosure forms must be
completed for the Sponsor and CRO.
Pre-Study Approvals
Research
Connect
Contract
Budget
Clinical Trials
Pre-Study Approvals
*IRB
*Additional
Approvals
* These Pre-Study Approvals are often managed by the PI or study team designee.
Research
Connect
Coverage Analysis Updates
Study Team
Study Activation Workflow
Central Team
Submission of
Minimum
Documents to
Contracting Offices
Contract
Execution &
FAU Issued
Contract Negotiation
CTAO Contracts
Grant
Grant Funding
Funding
Secured
Secured (if
(if
applicable)
applicable)
Feasibility
Feasibility
Initial
Submission to
webIRB
Ancillaries?
Ancillary
Submissions
YES
Budget Build
& Coverage
Analysis
OnCore Intake
Budget
Negotiation/
Completion
Draft Budget
Released to
Study Team
for Negotiation
YES
Is Budget
Build
Required?
Final Budget
Certification
Negotiated
Budget
Returned for
Certification by
CTAO
Ensure
conformity of
Negotiated
Budget,
Contract
Payment
Terms, IRBapproved
consent forms
and Admin
Costs
Study Team
Signoff(s)
Study
Activation
Validate OnCore Build and
Study Ready to Open to
Accrual
NO
IRB Review
IRB Approval
Clinical Content
Build and
Validation
Research
Connect
Coverage Analysis
• Leading intuitions use a formal Coverage Analysis
(CA) process to ensure compliant clinical research
billing.
• CA identifies all clinical items and services associated
with a clinical trial and identifies the financially
accountable party (Funding Source vs.
Insurance/Patient)
• Applicable to all clinical research studies that utilize
Health System Resources or “billable” items.
• Coverage Analysis Process at UCLA ends in a
certification by the Coverage Analysis Team
Research
Connect
Coverage Analysis
Research
Connect
•
•
•
•
Benefits of Coverage Analysis
Full Cost Recovery (UC Policy 95-05)
Prevents Double Dipping
Prevents Risk of Inducement
Appropriate Billing to CMS
Fraud can lead to OIG inspection and potential fines
and penalties in the millions! $$$
Coverage Analysis:
It doesn’t apply to my study!
Everything is billed to the study
NIH study
No investigational drug or device
Not using CareConnect
I’m only using Lab
Processing
IRB waived consent/Anonymous
Data
Coverage Analysis may still apply
Need Guidance?
Contact your Coverage Analyst
CoverageAnalysis@mednet.ucla.edu
Coverage Analysts assigned to a department.
Build a relationship to expedite reviews.
Pre-Study Approvals
Research
Connect
Contract
Budget
Clinical Trials
Pre-Study Approvals
*IRB
*Additional
Approvals
* These Pre-Study Approvals are often managed by the PI or study team designee.
Budget
Budget Development
Step 1: Review OnCore Draft Budget for accuracy
IRB No. (OnCore Protocol No.): 15-000894
PI: Velez, Frederico
Short Title: OPH Pediatrics Velez B&L
Arm 1: Study Drug A Monotherapy
Version: V1 (CRBP Signoff)
Treatment
Negotiated Rate
(enter rate)
Follow Up
Visit 1
1@1Days
Visit 2
1@1Days
Screening (Day -15)
Surgery/Randomization /Begin
Treatment
Day 1
Day 7
Day 14
Day 28
Day 42
Total per
procedure
Day 90
Informed Consent
S
0.00
Demographic Data
S
0.00
Current and relevant medical and ocular history
S
Occular Symptoms
S
S
S
S
S
S
S
S
0.00
VA Assessment
S
S
S
S
S
S
S
S
0.00
Slit lamp biomicroscopy or magnifying lens with penlight
S
S
S
S
S
S
S
S
0.00
Intraocular Pressure (IOP)
S
S
S
S
S
S
S
S
Clinic Visit†
0.00
255.00
Cataract Extraction with or without lens replacement†
255.00
0.00
255.00
255.00
255.00
255.00
255.00
255.00
2,040.00
247.50
247.50
247.50
247.50
247.50
247.50
1,485.00
19.50
136.50
RC1
0.00
Dispensing and Administration - Study Drug A (IV)†
Blood Draw
39.00
Pharmacokinetics
2S
19.50
S
19.50
S
19.50
S
19.50
S
S
*PI Time
0.00
-
*Study Coordinator Time
-
*Data Manager Time
-
*Central Lab Shipping and handling
Subtotal
Indirect Rate (26%)
Total
Enter rates in blue cells
* Budget only procedure/item
S = Sponsor pays for item
2S = event occurs twice at the visit; Sponsor pays for item
RC1 = Routine Cost, Q1 billing modifer (routine cost)
RC0 = Routine Cost Q0 billing modifier (investigational item)
255.00
255.00
541.00
522.00
522.00
522.00
522.00
522.00
3,662.00
66.00
66.00
141.00
136.00
136.00
136.00
136.00
136.00
952.00
321.00
321.00
682.00
658.00
658.00
658.00
658.00
658.00
4,614.00
Budget
Research Rates
Obtaining reduced research rates for ALL procedures & services.
Budget
Budget Development
Obtaining research rates for ALL procedures & services
Budget
Budget Development
Step 2: Supplement OnCore Draft Budget with Admin Costs to
create a UCLA study budget and
IRB No. (OnCore Protocol No.): 15-000894
PI: Velez, Frederico
Short Title: OPH Pediatrics Velez B&L
Arm 1: Study Drug A Monotherapy
Version: V1 (CRBP Signoff)
Treatment
Negotiated Rate
(enter rate)
Follow Up
Visit 1
1@1Days
Visit 2
1@1Days
Screening (Day -15)
Surgery/Randomization /Begin
Treatment
Day 1
Day 7
Day 14
Day 28
Day 42
Total per
procedure
Day 90
Informed Consent
150
150
150.00
Demographic Data
50
50
50.00
Current and relevant medical and ocular history
50
50
Occular Symptoms
50
50
50
50
50
50
50
50
50
400.00
VA Assessment
50
50
50
50
50
50
50
50
50
400.00
50.00
Slit lamp biomicroscopy or magnifying lens with penlight
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Intraocular Pressure (IOP)
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Clinic Visit†
255
255.00
Cataract Extraction with or without lens replacement†
Dispensing and Administration - Study Drug A (IV)†
255.00
0.00
0.00
255.00
255.00
255.00
255.00
255.00
255.00
2,040.00
247.50
247.50
247.50
247.50
247.50
247.50
1,485.00
19.50
136.50
RC1
0.00
248
Blood Draw
20
Pharmacokinetics
20
39.00
19.50
19.50
19.50
19.50
40
20
20
20
20
20
*PI Time
200
200.00
200.00
200.00
200.00
200.00
200.00
200.00
200.00
*Study Coordinator Time
140.00
1,600.00
100
100.00
100.00
100.00
100.00
100.00
100.00
100.00
100.00
800.00
*Data Manager Time
75
75.00
75.00
75.00
75.00
75.00
75.00
75.00
75.00
600.00
*Central Lab Shipping and handling
25
25.00
25.00
25.00
25.00
25.00
25.00
150.00
Subtotal
980.00
730.00
1,081.00
1,042.00
1,042.00
1,042.00
1,042.00
1,042.00
8,002.00
Indirect Rate (26%)
255.00
190.00
281.00
271.00
271.00
271.00
271.00
271.00
2,081.00
1,235.00
920.00
1,362.00
1,313.00
1,313.00
1,313.00
1,313.00
1,313.00
10,083.00
Total
Enter rates in blue cells
* Budget only procedure/item
S = Sponsor pays for item
2S = event occurs twice at the visit; Sponsor pays for item
RC1 = Routine Cost, Q1 billing modifer (routine cost)
RC0 = Routine Cost Q0 billing modifier (investigational item)
Budget
Budget Development
Step 2: Develop an Invoiceable Items List:
•
•
•
•
Non-refundable Start-up Costs
Annual renewal fees
Unscheduled events & assessments
Maintenance & closeout fees
Budget
Budget Development
Step 3: Compare the Sponsor’s Budget Template...
Budget
Budget Development
Step 3: …with the UCLA study budget
IRB No. (OnCore Protocol No.): 15-000894
PI: Velez, Frederico
Short Title: OPH Pediatrics Velez B&L
Arm 1: Study Drug A Monotherapy
Version: V1 (CRBP Signoff)
Treatment
Negotiated Rate
(enter rate)
Follow Up
Visit 1
1@1Days
Visit 2
1@1Days
Screening (Day -15)
Surgery/Randomization /Begin
Treatment
Day 1
Day 7
Day 14
Day 28
Day 42
Total per
procedure
Day 90
Informed Consent
150
150
150.00
Demographic Data
50
50
50.00
Current and relevant medical and ocular history
50
50
Occular Symptoms
50
50
50
50
50
50
50
50
50
400.00
VA Assessment
50
50
50
50
50
50
50
50
50
400.00
50.00
Slit lamp biomicroscopy or magnifying lens with penlight
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Intraocular Pressure (IOP)
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Bundled with
Clinic Visit
Clinic Visit†
255
255.00
Cataract Extraction with or without lens replacement†
Dispensing and Administration - Study Drug A (IV)†
255.00
0.00
0.00
255.00
255.00
255.00
255.00
255.00
255.00
2,040.00
247.50
247.50
247.50
247.50
247.50
247.50
1,485.00
19.50
136.50
RC1
0.00
248
Blood Draw
20
Pharmacokinetics
20
39.00
19.50
19.50
19.50
19.50
40
20
20
20
20
20
140.00
*PI Time
200
200.00
200.00
200.00
200.00
200.00
200.00
200.00
200.00
*Study Coordinator Time
100
100.00
100.00
100.00
100.00
100.00
100.00
100.00
100.00
1,600.00
800.00
*Data Manager Time
75
75.00
75.00
75.00
75.00
75.00
75.00
75.00
75.00
600.00
*Central Lab Shipping and handling
25
25.00
25.00
25.00
25.00
25.00
25.00
150.00
Subtotal
980.00
730.00
1,081.00
1,042.00
1,042.00
1,042.00
1,042.00
1,042.00
8,002.00
Indirect Rate (26%)
255.00
190.00
281.00
271.00
271.00
271.00
271.00
271.00
2,081.00
1,235.00
920.00
1,362.00
1,313.00
1,313.00
1,313.00
1,313.00
1,313.00
10,083.00
Total
Enter rates in blue cells
* Budget only procedure/item
S = Sponsor pays for item
2S = event occurs twice at the visit; Sponsor pays for item
RC1 = Routine Cost, Q1 billing modifer (routine cost)
RC0 = Routine Cost Q0 billing modifier (investigational item)
Budget
Budget Development
Step 4: Amend sponsor’s budget to include all UCLA Study Budget items
or ask Sponsor to use the UCLA Study Budget
Budget
Budget Development
Step 5: Negotiate a final study budget with the Sponsor
Tools for a successful negotiation
• UCLA Facilities & Administrative Cost Rates - http://www.res
earch.ucla.edu/ocga/sr2/idcinfo.htm
• F&A Rate (Overhead) applies to all budget items, except IRB
Initial Review Fee.
• This includes: funds for stipends, subcontracts, etc.
• Justification of Costs Memo that describes what each budget
item covers
• Know your minimum costs and where you have flexibility
Budget
Budget Development
Step 6: Submit the Final Sponsor-approved budget to your coverage
analyst for a Final Budget Certification
Final Budget Certification requires review of:
• Final Sponsor Approved Budget that comports with contr
act, protocol, consent form, IRB application and other ap
provals
• Final Contract
• IRB Approval with CA-compliant consent form
• Applicable Additional Approvals (i.e., Noridian Approval,
Technology/Value Analysis Committee, etc.)
• Sign offs in OnCore (ResearchConnect, for in-wave)
Pre-Study Approvals
Research
Connect
Contract
Budget
Clinical Trials
Pre-Study Approvals
*IRB
*Additional
Approvals
* These Pre-Study Approvals are often managed by the PI or study team designee.
*IRB
Consent Form – Cost Language
Research Only:
The study will pay for the cost of supplying and administering the study drug/device, and all required
study items and services as described in this consent form.
Mixed Cost:
The study will pay for research-related items and/or services that are provided only because you are
participating in the study. These research-related items and/or services are explained in other areas of
this consent form.
• You or your health plan may be responsible to pay for all the types of items listed below:
• Items and services that would have been provided to you even if you were not in the study
• Health care given during the study as part of your regular care
• Items or services needed to give you study drugs or devices
• Monitoring for side effects or other problems
• Deductibles or co-pays for these items and/or services
All Standard of Care:
There will be no additional cost to you or your health plan as a result of your participation in this study.
Items and services described in this consent form would have occurred regardless of your participation
in this study or, if research-related, will be provided to you at no cost.
*IRB
Billing Designations
IRB
application
Section
2.4
ICF Cost
Language
Budget/Contract
Pre-Study Approvals
Research
Connect
Contract
Budget
Clinical Trials
Pre-Study Approvals
*IRB
*Additional
Approvals
* These Pre-Study Approvals are often managed by the PI or study team designee.
*Additional
Approvals
Additional Approvals that may be Required
• Sponsor & Regulatory Documents
• UCLA Committees
• Medical Radiation Safety Committee (MRSC)
• Scientific Review Committee (ISPRC)
• UCLA Ancillary Services Departments
• Radiology Research Services
• Investigational Pharmacy Services
• Clinical Pathology Research Services (CPRS)
• Nuclear Medicine
*Additional
Approvals
Additional Approvals that may be Required
For Investigational Device Trials
• Financial Intermediary Approval
(Medicare Administrative Contractor - Noridian)
• Technology Analysis Committee/Value Analysis
Committee
Pre-Award
✔
Research
Connect
✔
Contract
✔
Budget
Clinical Trials
Pre-Study Approvals
✔
*IRB
✔
*Additional
Approvals
* These Pre-Study Approvals are often managed by the PI or study team designee.
Post-Award Issues
Reconciliation of Patient Care Costs
•
All study patient bills & charges must be reviewed for accuracy.
•
Contact billing office(s) for service areas and request that listing of charges be
sent for review and approval PRIOR to bills being charged to the study.
•
Review charges and compare with the Coverage Analysis Matrix to determine if
the charges were paid for by the sponsor or if they should be billed to insurance as
Routine Care.
•
Advise billing office(s) how each charge should be processed, and if it is paid for
the by the sponsor, at what rate it should be charged.
•
There are 2 Billing Offices: Hospital/Technical vs. Professional charges
•
Post-Award Issues
Determining Income Earned
Track each patient and all visits completed:
•
Track all invoiceable items:
Post-Award Issues
Invoicing
•
Studies must be invoiced in accordance with the payment
schedule in the contract.
• Payment schedules are unique for each study.
• In some cases, a sponsor may automatically generate payments based on data that is
collected.
• Do not rely on the accuracy of automatic sponsor payments. Instead, determine
income earned & compare with payment(s) received. In the event of a discrepancy,
invoice the sponsor for the outstanding balance.
• Invoiceable Items must still be invoiced to sponsors as these are not included in
automatic payments.
•
Most sponsors require invoices for ALL study costs (patient visits & invoiceables)
• Invoices must include: Patient #, visits completed, dates completed, and
appropriate accounting of costs.
• Invoice templates are available at the CTAO website
Post-Award Issues
Tracking Payments
•You may request that sponsors send payments directly to your attention.
• Please note: many sponsors will only send payments to the
address listed on the agreement (UCLA Remittance Center).
•
If payments are sent directly to you, make a copy of the check and corresponding
documentation prior to sending for deposit.
•
If the sponsor sends payments directly to the remittance center, request that the
sponsor send you supporting documentation that itemizes the payment received.
• Itemized payment spreadsheets will assist in reconciliation of payments
earned vs. payments received.
Post-Award Issues
Policy 913
•
If an unexpected balance remains after close-out of an expired or terminated fixedprice or fixed-rate contract or nonrefundable grant, at the Principal Investigator’s
request, applicable indirect costs will be applied to the balance and the remaining
amount may be converted to unrestricted funds to be made available to the Principal
Investigator.
•
To close a contract & transfer the unexpected balance to Policy 913 (fund 69970),
EFM will require confirmation for the following:
• ALL work has been completed & any applicable reports have been submitted.
• ALL study costs have been appropriately charged to the award fund.
• ALL invoices have been submitted.
• ALL anticipated payments have been received.
• No other expenses are expected to hit the ledger (e.g. payroll & other expenses)
http://www.adminpolicies.ucla.edu/app/default.aspx?&id=913
Post-Award Issues
Policy 913 (continued)
•
If the remaining balance is more than 25% of the total award, the following is required:
•
Principal Investigator must provide written justification explaining the balance
(carbon copy your MSO and Division Chief on the e-mail to EFM).
•
Once EFM has received the required information, EFM will close the fund and transfer
the unexpended balance to fund 69970.
•
Important Points to Remember:
No expenses are allowed that originally occurred outside contract approval dates.
•
EFM will transfer the TOTAL cost balance to 69970 and the Dean’s Office will recharge
the indirect costs quarterly.
Example: Total Unexpended Balance is $1,575 (inclusive of $325 indirect costs)
$1,250 (Direct) + $325 (Indirect) = $1,575 total (EFM will deposit entire amount into fund 69970
However, Dean’s Office will recharge (debit) your account $325 indirect costs. SO DON’T SPEND IT!!
Contracts & Grants Offices
Clinical Trial Administration Office (CTAO)
• Clinical Trial Agreements (CTAs) funded by industry sponsors (for-profit).
•
Includes Investigator-Initiated & Sponsor-Initiated.
Office of Contract & Grant Administration (OCGA)
• Clinical Trials funded by non-profit organizations, including state and federal
government agencies (NIH, FDA, CMS, DOD, VA, etc.)
•
Agreements related to research, but do not meet the definition of a “Clinical Trial”
Office of Intellectual Property & Industry Sponsored Research (OIP-ISR)
• Research Agreements funded by industry sponsors (for-profit).
•
License agreements for University held patents, copyrights, etc.
Contact Info & Questions?
For CTAO or Clinical Trial Contract Questions:
ClinicalTrials@mednet.ucla.edu
For Coverage Analysis Questions:
CoverageAnalysis@mednet.ucla.edu
Maggie Lindenbaum
Project Manager
Clinical Trials Administration Office
mlindenbaum@mednet.ucla.edu
310-794-3788