heather offhaus director grant review & analysis university of michigan medical school...
TRANSCRIPT
![Page 1: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/1.jpg)
HEATHER OFFHAUSD I R E C T O RG R A N T R E V I E W & A N A LY S I SU N I V E R S I T Y O F M I C H I G A N M E D I C A L S C H O O L
h m i l l s @ u m i c h . e d u
BRIAN FARMERS e n i o r D i r e c t o rA c a d e m i c A ff a i r sC l e v e l a n d C l i n i cb f a r m e r 2 @ c c f . o r g
Managing Clinical Trials For Break Even
![Page 2: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/2.jpg)
What will I hear today?
We’ll discuss the primary issues in a financially successful clinical research enterprise
We’ll discuss the elements of a well developed budget Identify the funds on the front end by budgeting well Identify funds through negotiation
We’ll discuss some processes we use to manage financial results. Identify funds through consistent invoicing and bookwork Identify funds through careful tracking
![Page 3: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/3.jpg)
Can I really be Financially Successful?
It has to be a Departmental/Institutional Choice
It is a Philosophical and a Process
You have to Talk about it, Get Buy-In
Define what you Mean by Financially Successful
You must Build an Enterprise
![Page 4: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/4.jpg)
Clinical Trial Team
One of the most integrated groups
How do you surround yourself?Principal InvestigatorClinical Study Nurse / Trial CoordinatorSponsor / CRO
(though maybe at a longer arm length!)
![Page 5: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/5.jpg)
Extensions of Clinical Trial Team
Billing Calendar Review OfficeHuman Subjects Protection OfficeContract Negotiation Group / Sponsored
Programs OfficeAncillary Review Committees
![Page 6: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/6.jpg)
Specialized Expertise
Use your Competitive Advantage in Negotiations
Do you have Personnel, Techniques, IP that you can Leverage/
Do you Truly have Specialized PatientsGeographic Advantage
![Page 7: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/7.jpg)
Determine Recruitment Potential
Define reasonable & realistic accrual goals
• What measures are necessary to reach the desired subject population?
• How many subjects must be screened to identify an eligible participant?
• What is the recruitment time frame?• What is my patient population?
![Page 8: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/8.jpg)
DISCLAIMER!!!
We will talk through types of charges
We will offer many ways of looking at things
BUT, this is not the exhaustive list!
Many items are protocol/institution specific
![Page 9: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/9.jpg)
Clinical Budget Full Budget Concepts:
Needs to be somewhat flexibleIf not in budget, sponsor is not
obligated to payMust cover all costs
![Page 10: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/10.jpg)
Categorize Budget Items
Fixed and Up-Front Costs
Are needed for study conduct and incurred whether or not a subject is enrolled.
Costs Related to Subject Visits
Sponsor proposals usually link all budget items directly to patient visits.
![Page 11: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/11.jpg)
Identify Universal Costs for Study Conduct
What institutional approvals are needed and need funding?
Are mandated fees charged?Determine institutional Indirect Cost
rate
![Page 12: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/12.jpg)
Indirect Cost Recovery (aka Facility & Administrative charges or Overhead)
Determine correct rate to use on your study
Call your institutional resource!
These are a real cost to the institution
![Page 13: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/13.jpg)
Budgeting a Clinical Trial
Clinical Trial experience is helpful when creating and negotiating budgets
• Understand the nuances of treatments
• Things are not black and white
• There is a patient at the other end of the trial
• The care always has to come first over the protocol
![Page 14: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/14.jpg)
Dissecting the Protocol
• Study Calendar• Identify items that will generate expenses for the site
• Number and complexity of subject visits
![Page 15: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/15.jpg)
Dissecting the Protocol
• Study Calendar• Identify items that will generate expenses for the site
• Number and complexity of subject visits
• Laboratory Assessments (Examinations)• Knowing exactly what is included in each lab cost is key
![Page 16: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/16.jpg)
Dissecting the Protocol
• Study Calendar• Identify items that will generate expenses for the site
• Number and complexity of subject visits
• Laboratory Assessments (Examinations)
• Study Design• Study duration
• Accrual goal
• Number of participating sites
• Cycle length and/or limit
![Page 17: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/17.jpg)
Billing Calendars
Produce list of study procedures / calendarPrincipal Investigator designates Standard
of Care items versus research related itemsBilling Calendar becomes the foundation of
your budget
![Page 18: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/18.jpg)
Billing CalendarForm to take on visit to PI to identify standard of care v. chargeable
items
Screen Cycle 128 Day Cycle
Cycle 228 Day Cycle
Cycle 328 Day Cycle
CPT CDM Day-14 to -1 Day 1Day 8 Day 15 Day 22 Day 1 Day 8 Day 15 Day 22 Day 1 Day 8 Day 15 Day 22
OFFICE VISITS
Physical Examination 99214 26339 RC RC RC RC
LABS
Hematology - CBCPD 85025 35501 RC RC S RC S RC S RC S RC S RC S
Serum Chemistry - COMP 80053 20548 RC RC RC RC RC RC RC
Uric Acid 84550 20701 S S S S S S S
Serum Pregnancy Test 84702 23305 S S S S
Urinalysis - Macro 81003 35303 RC S RC RC
Urinalysis - Micro 81015 35303 S S S S
PROCEDURES
CT Scan - Abdomen 74160 33971 RC RC
![Page 19: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/19.jpg)
Preparing the Budget
![Page 20: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/20.jpg)
Salary Recovery Estimates
• Recovery Estimate Sheet for:• Principal Investigator• Additional faculty / clinician participation• Data Manager/Coordinator• Regulatory Manager/Coordinator• Research/Treatment Nurse• Medical Assistant• Multi-site Study Coordination
• Consider support for:• Finance/Accounting • IT Support for Clinical Research• Difficulty of meeting eligibility criteria• Additional recruitment effort
![Page 21: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/21.jpg)
Consider “Hidden” Study Costs
Delayed start Informed consent processIncreased salaries & operating costs over
timeTravel to clinics or offsite locations
Hotel Stays Tolls / Mileage Meals
![Page 22: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/22.jpg)
More “Hidden” Study Costs
Unscheduled visits Overhead costs for “a la carte” or
one-time procedures Tracking study fundsAudits
![Page 23: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/23.jpg)
Consider Closing Costs
Don’t forget – Closing costs occur AFTER subjects complete
study and BEFORE contract ends
• Query resolution to close database• Sponsor’s close-out visit• Pharmacy close-out• IRB termination• Long-term storage of research records
![Page 24: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/24.jpg)
Potentially Unallowable Costs:
• Finder’s fees/Referral fees
• Enrollment incentives
• Paperwork completion incentives
![Page 25: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/25.jpg)
Feasibility Comparison
The comparison of what you truly need to what you can negotiate….
How do you identify the “institutional investment” in a project?
Always compare any sponsor offered amounts with information you have
When do you say (for financial reasons) you can’t do a study?
![Page 26: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/26.jpg)
Negotiation
• Areas of resistance:• Study team salaries
• Start up fees
• Expensive procedures
• Procedures should be “standard of care”
![Page 27: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/27.jpg)
Tips to overcome resistance:• Justification outline of start up fees• Increase cost of one item to reduce the cost of another• Additional invoicable items• Ask for more than you need, so you can reduce costs
and satisfy sponsor later• Clarify procedure requirements to see if a less
expensive option can be used
*Remember, the sponsor WANTS to work with you!
Negotiation
![Page 28: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/28.jpg)
• Final Logistics Meeting• Identifying equipment/medications/supplies
provided by sponsor (Kits for labs, PK draws, etc.)
• Verifying number of patients expected to accrue
• Fielding questions/feedback from study team that need to go to sponsor in financial areas
• Logistics for conducting trial
• Reviewing draft financial terms from the sponsor
Bring the Team back together
![Page 29: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/29.jpg)
On Going Financial Analysis
Review during the study is criticalExamine the Data Available to youIndependent Review is CriticalAdopt Procedures and Follow ThemDon’t be Afraid to Pull the Plug
![Page 30: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/30.jpg)
Our Process
Research Budget
Include Costs of Clinical Research
Choose Proper Metrics be Transparent
Measure Performance Against Metrics
![Page 31: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/31.jpg)
Metrics and Who is Responsible
Financial Reports Prepared Centrally, Distributed by Post Award Focus of study reports, P/L, Not Budget FTE’s by funding (Phantoms, Labor Pools)
Enrollment DataBilling DataEarned but Not billedOther Data?
![Page 32: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/32.jpg)
Bi-monthly Budget Review
Review of Overall Budget Performance
Finance Personnel
High Level Reports
Detailed Discussion as Needed
![Page 33: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/33.jpg)
Bi-monthly Budget ReviewSample Research P/L
![Page 34: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/34.jpg)
Bi-monthly Budget ReviewSample Metric Report
![Page 35: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/35.jpg)
Quarterly Reviews
Financial StatusDeliverable StatusExamination of Individual StudiesFocus
Past End Date Closing soon Deficit Status Inactive Others
![Page 36: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/36.jpg)
Past End Date or Closing Soon
Financial PositionStatus of DeliverablesStatus of ARStatus of Earned Not BilledClose or Extend
![Page 37: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/37.jpg)
Deficit Status or Inactive
Financial StatusBilling/Payment StatusDiscuss Identified IssuesDevelop Corrective ActionClose Study
![Page 38: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/38.jpg)
Other Discussions for Quarterly Meetings
PI issues requiring interventionCentral Office AssistanceSponsor ProblemsIRB IssuesOther
Communication is Key to any Enterprise!
![Page 39: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/39.jpg)
Other Issues: Renegotiation
If Science is Good, Renegotiate the Troubling Issues
May be Better For Sponsor to Re-Negotiate
Adjust ProtocolThe Worst they can Do is Say NoAsses Institutional Relationship with
Sponsor
![Page 40: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/40.jpg)
Other Issues: IRB
Good Communication with the IRBIRB Approved Protocols without a
Study Account Set-up (Phantom/Orphan)
Informed Consent that Hurts EnrollmentRenewals/Changes
![Page 41: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/41.jpg)
Other Issues: Various
Timing of Gain/Loss RecognitionResearch Billing
Timing Review of charges to studies Error Correction SOP
Collection from SponsorMonitor VisitsTraining of Personnel (duties outside their
background)COMMUNICATE
![Page 42: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/42.jpg)
Other Issues: Residuals
Must Have Written PolicyF & A on ResidualsDistribution ProcessTax ImplicationsRestricted UseInstitutional Funds
![Page 43: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/43.jpg)
Summary
Know your BusinessDevelop Good BudgetsMonitorInvolve the Whole TeamMonitorWork with the SponsorMonitor
![Page 44: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/44.jpg)
Communication is Key
With PIWith FinanceWith Billing StaffWith Sponsor
The Entire Team, Internal and External
![Page 45: HEATHER OFFHAUS DIRECTOR GRANT REVIEW & ANALYSIS UNIVERSITY OF MICHIGAN MEDICAL SCHOOL hmills@umich.edu BRIAN FARMER Senior Director Academic Affairs Cleveland](https://reader036.vdocuments.us/reader036/viewer/2022070412/5697bf861a28abf838c8804b/html5/thumbnails/45.jpg)
Questions?
Heather Offhaus Director Grant Review & Analysis University of Michigan Medical School [email protected]
BRIAN FARMERSenior DirectorAcademic AffairsCleveland [email protected]