Project Management and Budgeting - The Ottawa Hospital ... - Wkshp 3... · project management and...

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PROJECT MANAGEMENT AND BUDGETINGBEST PRESENTATION EVER!

PRESENTED BY MARC VENTURIPROGRAM ANALYSTOCTOBER 17, 2016

Affiliated with • Affilié à 2

I have no conflicts of interest related to this presentation

▶ Overview of Project Management in Research

▶ Tools• Work Breakdown Structure, Gantt, Tracking

▶ Going to the budget▶ Steps with examples▶ Negotiations▶ Grant vs Industry▶ Odds and Ends

OUTLINE

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▶ 45% of trials fail to reach 80% of pre-specified sample size.

▶ Less then 1/3 of trials recruit their original target number of participants with the time originally specified.

▶ 1/3 of trials need to be extended in time and resources.

▶ 1/10 trials never enroll a single patient▶ According to the FDA only 6% of trials

complete on time

WHY BOTHER?• Trial emphasis is on

Scientific data and compliance. Need to place a much higher emphasis on conduct.

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▶ Defining scope• Defining the project

▶ All people

▶ All steps

▶ All costs

▶ Project Plan (road map)

All for just a few hours a month

WHAT IS PM ABOUT?• Managing risk!

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TRADITIONAL PROJECT MANAGEMENT AND CLINICAL RESEARCH

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InitiationAnalysis and

ReportingMonitoring and

Compliance

▶ Visual guide to every aspect of a trial• Includes leaders for each task

▶ Focus on “what”, NOT “how”. • How is taken care of by the leads

▶ Plan outcomes not actions

▶Nouns not Verbs

WORK BREAKDOWN STRUCTURE• WBS

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WBS EXAMPLE – ROCK CONCERT

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ANOTHER EXAMPLE – CLINICAL RESEARCH

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Project (initials)

A:Governance and

Management

A1: Core Team A2: DSMB

A2.1 Annual Reporting

A3: Steering committee

B: Approved Research Plan

B1:Health Canada Approval

Monitoring Plan

B2: REB Approval B3: Contracts

B3.1: SITE1

C: Data

C1: Data Collection

D:Analysis and Results

E: Knowledge mobilization

WBSALTERNATIVE LAYOUT• WBS

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Project X (initials)

1. Governance and Management (XX)1. Core Team2. DSMB

1. Annual Reporting3. Steering Committee

2. Approved Research Plan (XX)1. Health Canada Approval(XX)

1. CTA2. Site Information Form

2. Monitoring plan3. REB approval

1. Consent form1. Translated to French

4. Medical Imaging Approval5. Pharmacy Approval6. Cardiovascular services approval7. Contracts

1. Site 1

WBS CONTINUED

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▶ List/map items according to how it makes sense for you and your team

▶ Should include all deliverables (not actions)• Regularly test it

• Update it accordingly

▶ Becomes the foundation for all other work.• Think of this as a checklist with some

additional details and features

GANTT CHARTS“fancy” scheduling tool- How to develop your project schedule

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▶ List deliverables based on WBS▶ Carefully note time required for each

deliverable▶ Identify deliverables with dependencies or

strict time constraints▶ Starting with your last deliverable build

your schedule taking into account the above

▶ Don’t forget milestones!▶ Adjust until the schedule fits and there are

not bottlenecks

GANTT CHART EXAMPLE

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GANTT CHART EXAMPLE 2

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No Deliverable/Subdeliverable

A Governance and ManagementA1 Core TeamA2 DSMBB Approved Research PlanB1 REB ApprovalC Data AcquisitionC1 RecruitmentC2 Data CollectionD Analysis and ResultsE knowledge Moviliation Km

Jan-17

Governance and Management

Research Plan

Data Acquisition

Analysis and Results

Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16

CRITICAL PATH AND TIPS

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▶ Identify sequence of activities that defines the end date• Critical path item is delayed by a month the

whole project is off by a month

▶ Identify non-critical path activities• Non-critical means they are flexible

▶ In research there is always uncertainty regarding what activities are critical or near-critical. Near is critical

▶ Look over your seemingly independent events for relationships• Analysis and results cannot occur before data

is acquired.

▶ Drives progress in the context of WBS and Schedule

▶ Every month, quarter or biweekly, a new worksheet is populated in the tracking sheet• Provides snapshot of progress and near-term

planning• Color provides relative change and

understanding at a glance

▶ Eliminates the need for many other documents. E.g.. Detailed minutes, list of action items• Estimate time required is 3-6hours/month to

complete all.

RPM TRACKING SHEET• Source: Research

Project Management www.researchpm.comAlison Paprica PhD PMP

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http://www.researchpm.com/

RPM TRACKING – EXAMPLE 1

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Task/Milestone 1 sk/Mileston Task/Milestone 6

Upcoming 4-6 Tasks/Milestones and Target Completion Dates (changes relative to last version

highlighted with blue, italic, bold font)

No. Deliverable/ Subdeliverable Name

Lead Initials

Last Accomplishment or Completed Task/Milestone

Status (Green, Yellow, Red)

RPM TRACKING – EXAMPLE 2

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Task/Milestone 1 Task/

B1 Monitoring Plan MFIdentified group willing to swap time for monitoring Green

Confirm ability to monitor study over 2 year term and Set dates.

C Analysis and Results DWD Not Started

B2 REB AT Submitted REB form to OHSN-REB GreenLetter of concerns to be addressed.

Upcoming 4-6 Tasks/Milestones


Lead Initials



January 11, 2016

January 25, 2016

Task/Milestone 1 Task/M

B1 Monitoring Plan MF

TD and FE from Othro have agreed to Monitor our study on July 24, 2016, and MF will monitor their study in August. -Sched to abe adjusted Green

C Analysis and Results DWD Not Started

B2 REB AT

Letter of concerns received. - Significant issues, will require 2nd review by full board. Yellow

Letter of concerns to be addressed.

Upcoming 4-6 Tasks/Milestones


Lead Initials



▶ Planning for too many activities in the last quarter of month of funding.

▶ Recognizing and responding to risks to late.

▶ Too little delegation of work.▶ Straight application of standard Project

Management Tools. ▶ Insufficient support for novice Project

Managers/ Coordinators.

COMMON MISTAKES

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ON TO BUDGETS!

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WHEN AND WHY

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▶ When• ASAP

▶ Why• Should you conduct a trial that will lose $?

• Accurate costing adds value to grant proposals

Affiliated with • Affilié à

STEP 1 – STAFF COSTS

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Hourly wage

(everything in)

Important time on

Non-Working activities

Time working

Productivity Adjusted Cost/hr

STEP 1

STAFF COSTS

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Compensation Components Coordinator 2Current Annual Salary/Expected earnings 70,000.00$ Expected Salary increase / year 3%Salary in Year 2 72,100.00$ Salary in Year 3 74,263.00$ Salary in Year 4Total Days 260Vacation Days 20Holidays 10Sick Days 5Investigator meetings, pass, siv and Training 15Available days 210Hours in a day 7.5Adjusted annual available Hours 1575Hourly wage before benefits 36.99$ Benefit Percentage 24%Cost of all benefits 17,309.04$ Adjusted employee cost 89,430.04$ Fully Loaded employee cost per hour 56.78$ Productivity rate 90%Productivity adjusted cost per hour 63.09$

STEP 2

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▶ Read the ENTIRE protocol▶ Compare the schedule of tests (if

there is one)▶ Make your own schedule – (essentially

the WBS in list form)• All steps for each study visit

• Including procedure and tests.

TASK IDENTIFICATION


SCHEDULE OF TESTS – FROM INDUSTRY

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Study Task Rate Visit 1 Visit 2 Visit 3Informed Consent 150.00$ 150.00$ Inclusion/Exclusion 100.00$ 100.00$ 100.00$ Medical History 125.00$ 125.00$ 125.00$ Randomization 110.00$ 110.00$ Brief Physical exam 75.00$ Vital Signs 25.00$ 25.00$ 25.00$ 25.00$ Complete Physical Exam 200.00$ 200.00$ Wound Site assessments 75.00$ 75.00$ ECG 25.00$ 25.00$ Lab draw and processing 40.00$ 40.00$ 40.00$ 40.00$ Urinalysis 25.00$ 25.00$ Adverse Events 20.00$ Drug distribution accountability 15.00$ Pharmacy dispense fee 5.00$ 5.00$ 5.00$ Subtotal 770.00$ 165.00$ 305.00$



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Study Task Visit 1 Visit 2 Visit 3Informed Consent XInclusion/Exclusion X XMedical History X XRandomization XBrief Physical examVital Signs X X XComplete Physical Exam XWound Site assessments XECG XLab draw and processing X X XUrinalysis XAdverse EventsDrug distribution accountabilityPharmacy dispense fee X X



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Study Task WhoHourly or OHIP Rate

Final Hourly

Rate

Time Based costsInformed Consent Coordinator 65.91$ 120 131.81$ Inclusion/Exclusion Coordinator 65.91$ 15 16.48$ Medical History Coordinator 65.91$ 45 49.43$ Randomization Coordinator 65.91$ 30 32.95$ Brief Physical exam PI OHIP 65.91$ 1 -$ Vital Signs Coordinator 65.91$ 10 10.98$ Complete Physical Exam PI OHIP 1 -$ Wound Site assessments PI OHIP 1 -$ Coordinator fee 65.91$ 60 65.91$ Investigator fee PI HOURLY 333.38$ 10 55.56$ Patient Stipend (parking+meal+cab) Patient 50.00$ 60 50.00$

Time for Task for Study per visit

Beyond standard of care (minutes)

= 1 if OHIP

▶ Build your own spreadsheet of all costs that are not your own labour costs• Medical imaging

• Laboratory & Pathology

• Pharmacy

• Cardiopulmonary services

• Methods center

• Other hospital or research services….

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STEP 3• Non-Staff Costing


PHARMACY EXAMPLE

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Service Category Service Details of Service 2015-2016 Administrative/Start/Close

Start-up Protocol Review and official Quote Preparation, Setup of study binder and drug logs, Study initiation (SIV), Start-up meetings, Correspondence, Protocol specific training, Labelling requirements and Determining drug stability

$ 1,500.00

Annual Service Charge Maintenance of documentation, basic inventory control (ordering, vendor returns, Shipment time)

$ 600.00

Amendments Changes/Revision to study procedure $ 200.00 Study Closeout $ 300.00 Inventory Control

Drug Receipt $ 25.00 Drug Destruction Charge for time to destroy drugs. $ 50.00 Additional Supplies and medication not provided by sponsor

If additional supplies are required the pharmacy will order with an additional charge to compensate for administrative time.

Actual +25%

Dispensing Fees

Dispensing Fee: PO Level I Dispensing of pre-manufactured drug $ 30.00 Dispensing Fee: PO Level II Dispensing requiring compounding $ 40.00 Dispensing Fee: IV Level I Preparation of IV solution $ 45.00 Dispensing Fee: IV Level II Preparation of complicated IV and chemotherapy solutions $ 85.00 Additional Services

Randomization /patient Per patient charge to randomize treatment $ 15.00 Lab Tests Dosage consultation $ 20.00 On-Call Fee /month If study requires on call services, a portion of the total will be charged (the cost is shared

amongst other studies requiring on-call services) $ 875.00

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STEP 4• Summarize

Cost/Visit/Patient

Staff Costs Tests and other Non-Staff costs

OverheadMaintenance and licensing

Cost per visit/patient

If Necessary

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STEP 4• Cost/Visit/Patient

Week 1 4 52

Rate Visit 1 Visit 2 Visit 14 TotalStaff Fees

Informed Consent 131.81$ 1 1Inclusion/Exclusion 100.00$ 1 1Medical History 125.00$ 1 1Randomization 110.00$ 1 1Brief Physical exam 75.00$ 0 0Vital Signs 25.00$ 1 1 1 14Complete Physical Exam 200.00$ 0Wound Site assessments 75.00$ 0Coordinator fee 75.00$ 1 1 1 14Investigator fee 100.00$ 1 1 1 14Patient Stipend (parking+meal+cab) 50.00$ 1 1 1 14

Cardiopulmonary ServicesECG 25.00$ 1 1 5

Diagnostic ImagingMRI (1 scan) 715.00$ 2 2 7

LaboratoryUrinalysis 25.00$ 1 1 5Lab draw and processing 40.00$ 1 1 5

PharmacyPharmacy dispense fee 31.00$ 1 1 5

-$ Subtotal 837.81$ 1,680.00$ 1,801.00$ 9,576.81$ Overhead 30% 251.34$ 504.00$ 540.30$ 2,873.04$ Equipment Maintenance and licenseing 2% 16.76$ 33.60$ 36.02$ 249.00$ Total Cost per visit 1,105.91$ 2,217.60$ 2,377.32$ 12,641.39$

Study Task


STEP 5 – START-UP AND CLOSE OUT

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Personnel costs• Protocol review• Consent review and

mods• Departmental approvals• Document collection• Budget prep• Ethics application• PI submission review• SIV • Regulatory prep• Study Team meeting• Feasibility questionnaire• Close out processing

Departmental and Review

• Pharmacy/year• Randomization (pharmacy)• REB• Radiation Safety Committee• Diagnostic Imagine Review• Cardiopulmonary review fee

Admin/Office

• Fax line• Pager• Long-distance• Printing• Courier• Mail• File Storage (25 years)

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STEP 5• Start-up and Close

out

Start-up/Close-out Step Program Manager Coordinator

Protocol Review 7 2 780.86$ 234.26$ Consent Form review and modification based on REB review 15 1,301.43$ 390.43$ Departmental approvals - Protocol submission 4 347.05$ 104.11$ Collection of essential documents, signature and forwarding. 2 173.52$ 52.06$ Budget preparation for Ethics 8 694.10$ 208.23$ Ethics Application form Preparation 8 694.10$ 208.23$ Review and approval of ICF's, Budget and Ethics -$ -$ Attendance of SIV 2 6 694.10$ 208.23$ Documents and start-up training 2 6 694.10$ 208.23$ Prep of regulatory and correspondence binder 2 2 347.05$ 104.11$ Study team meeting 1 1 173.52$ 52.06$ Feasibility Questionnaire 0.25 21.69$ 6.51$ Close-out processing 8 694.10$ 208.23$

Departmental and Review fees -$ Record Storage (25 years) 1,500.00$ 1,500.00$ 450.00$ Pharmacy -Per year1 1,545.00$ 1,545.00$ 463.50$ Randomization 16.00$ 16.00$ 4.80$ Drug Receipt & destruction 78.00$ 78.00$ 23.40$ Pharamcy Closeout 309.00$ 309.00$ 92.70$ Radiation Safety Review 400.00$ 400.00$ 120.00$ Diagnostic Imaging Review fee 78.00$ 78.00$ 23.40$ Cardiopulmonary review fee 60.00$ 60.00$ 18.00$

Administrative/Office Expenses -$ Dedicated fax line 150.00$ 150.00$ 45.00$ Pager 100.00$ 100.00$ 30.00$ Printing 25.00$ 25.00$ 7.50$ Courier/Mailing 100.00$ 100.00$ 30.00$

-$ -$ Total 51.25 25 4,361.00$ 10,976.61$ 3,292.98$

Maintenance charge 219.53$ TOTAL INCLUDING OVERHEAD 14,489.13$

Line Total

Personnel expenses

Hours Spent On TaskPrice Overhead

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STUDY STARTUPAGREEMENT


PASS THROUGH COSTS

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Pass Through Items -Invoicable Price Overhead Maintenance TotalREB review Fee 3,000.00$ 3,000.00$ REB Annual Review fee 500.00$ 500.00$ CRA visit (per visit) 80.00$ 24.00$ 2.08$ 106.08$ Pharmacy Audit Fee 206.00$ 61.80$ 5.36$ 273.16$ Pharmacy Ammendment 206.00$ 61.80$ 5.36$ 273.16$ Clerical services (per hour) 25.00$ 7.50$ 0.65$ 33.15$ Chart retrieval On Site ( per chart) 2.00$ 0.60$ 0.05$ 2.65$ Chart Retrieval Off-Site (per chart) 6.00$ 1.80$ 0.16$ 7.96$ Amendment Report - complex, with ICF changes 1,300.00$ 390.00$ 33.80$ 1,723.80$ Amendment Report - Minor without ICF Changes 650.00$ 195.00$ 16.90$ 861.90$ Translation services (per word) 0.26$ 0.08$ 0.01$ 0.34$ Adverse Event Reporting 20.00$ 6.00$ 0.52$ 26.52$


FINALIZATION

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Institutional Overhead Rate 30%

Surplus/Loss CalculatorTotal Start-up and Close out costs 10,976.61$ Sponsor Will provide 6,000.00$ Total operational Cost per patient 12,641.39$ Sponsor Will provide per patient 16,000.00$ Expected number of patients 4Expected surplus or loss (-) to conduct this study with the expected number of enrolled patients. 6,537.82$


FINALIZATION

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Institutional Overhead Rate 30%

Surplus/Loss CalculatorTotal Start-up and Close out costs 10,976.61$ Sponsor Will provide 6,000.00$ Total operational Cost per patient 12,641.39$ Sponsor Will provide per patient 16,000.00$ Expected number of patients 2Expected surplus or loss (-) to conduct this study with the expected number of enrolled patients. 179.40-$

▶ Do not dismiss the value of making your budget look pretty• Be consistent

• Use headers to classify information

• Use colors if necessary but sparingly▶ Use colors that can be represented in

black and white

• Do not hesitate to include descriptive information.

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BUDGET PRESENTATION

▶ Know your target and walk-away price▶ Know what you and your team bring to

the table• Patients• Skills• Track record

▶ Options • Black box• Open book• Mix

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NEGOTIATING

▶ Overhead • Contracts, regulatory guidance, ethics,

internal monitors/auditors, HR, Finance, Technology Transfer, Health and Safety, Health and Safety, Purchasing, Communications, Utilities (Hydro, water, Housekeeping, etc..)

▶ Equipment Maintenance (2%) direct• PC software licensing, IT, Maintenance

• Must be a “scientist” in OHRI space

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OVERHEADAnd Equipment Maintenance

▶ Equipment purchases: freezers, centrifuge, computers, service contracts

▶ Travel▶ DSMB costs▶ Sample procurement: tubes, needles, wipes,

slides, pipettes…▶ Data collection and analysis▶ Statistician consult▶ Data entry personnel▶ Office expenses: courier, telecom, etc.▶ Drug costs, placebo, shipping▶ And much much more.

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GRANT VS INDUSTRYGrant budget can also include:

▶ Consult your finance department (or me)• Appropriate coding of expenses and

revenue (that’s finance, I don’t like doing that)

▶ Monitoring and compliance• Review budget monthly, quarterly and

annually and forecast

• Prior to completion (90 days) conduct a full financial review

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USE YOUR ORGANIZATIONFor those here: That’s me.

Affiliated with • Affilié à 45

▶ Income• Include arrived $ and what

you have sent out invoices for

“AND THE BUDGET WILL BALANCE ITSELF”

▶ Expense• All purchases

• Time

• Broken down by patient if possible.

▶ Follow the same principles▶ Travel can be a BIG item▶ Use per patient budget with subsites

• Be fair but stringent

• Need to have extra-funds to deal with contingencies

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MULTICENTER TRIALSHow can something have more than one middle…?

“It’s clearly a budget. It’s got a lot of number in it.”

-George W. Bush

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QUESTIONS PERIOD – SOME EXAMPLES BELOW.. THOUGH.. THEY AREN’T VERY GOOD..

▶ Who are you, and what are you doing here?▶ Where did you get that nice suit?▶ After sitting through this I smell purple. Is that a

normal?

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