Developing a Study Budget and Contract - Temple University

Developing a Study Budget 

and Contract 

Arleen Wallen 

Department Administrative Director 

HSC ‐ Office of Clinical Trials 

Administration 

February 14, 2013

Overview 

•Types of Agreements 

•Sponsor Budgets 

•Considerations 

•Sample Sponsor Budgets 

•Sample TU Clinical Trial Budgets

Confidentiality Agreements 

• A CDA is an agreement between the sponsor and the 

University which allows the sponsor to provide a protocol 

to the investigator. It is intended to maintain 

confidentiality of the protocol. 

• In order to protect the University and the investigator, 

this agreement must be reviewed and approved by 

OCT/HSC Legal Counsel. 

• Clinical Trials Administration will process the CDA on 

behalf of the Institution

LOI’s and LOA’s 

• LOI – Agreement between University and Sponsor 

for Indemnification subject injury protection for 

Institution and Subject when CRO is signing the CTA 

• LOA – Letter of Authority when CRO signing for 

Sponsor and CTA includes Indemnification and 

subject injury clauses.

CTA – Clinical Trial Agreement 

Typical Contract Structure 

•General Provisions 

•Special Provisions 

•Miscellaneous Provisions 

•Exhibits & Addenda

Who are the SPONSORS? 

• Pharmaceutical/Medical Device 

Companies 

• Biotech Companies 

• CRO (Contract Research Organization)

Master Agreements (15) 

• Abbott Vascular 

• Amgen 

• Biogen 

• Celgene 

• Duke Rapid Start 

Network 

• Genentech (Roche) 

• GlaxoSmithKline 

• Intermune 

• Medtronic 

• Merck 

• Novo Nordisk 

• Novartis 

• Sanofi 

• Scripps Consortium for 

Liver Research 

• St. Jude

General Provisions 

• Scope of Work: describes the work in 

summary form and incorporates the Study 

Protocol. 

• Personnel: Identify PI & Sub‐investigators 

and what will be done if PI is no longer 

affiliated with institution. 

• Term: Length of study either by date or by 

completed action required under the 

contract.


• Recordkeeping and Access: Describe the terms 

under which the sponsor will have access to original 

study documents and to audit (usually normal 

business hours with reasonable notice). 

• Notice: Who to contact in the event particular info is 

needed from either the Institution or the Sponsor 

and how notice is effectuated.


• Assurances: That the Site meets regulatory 

requirements regarding things like Good Clinical 

Practices, IRB approval, HIPAA; Use of most recent IC 

• Independent Contractor: and specifically not an 

agent of the Sponsor; 

• Use of Name: That parties will not use each others 

names in any promotional activity with out consent; 

pre‐approval for use of website.

Costs and Payment Terms 

Payment terms 

• Incorporated in body of agreement 

• Or as Attachment 

• Sometimes negotiated with 

separate person 

• Sometimes requires separate PI 

signature

Additional Issues with Contracts 

• Use of Clinicaltrials.gov Registry 

• IC 

• Insurance 

• Choice of Governing Law 

• Sufficient Payment for Overhead, Coordinator, 

and Hidden Expenses

ClinicalTrials . Gov 

Listing in ClinicalTrials.gov. now required by law 

Stephanie Brictson (2-9190) can assist with Registering 

Non-Industry sponsored trials

Sample Publication Clauses 

• Sponsor shall (without written authorization) 

allow Institution to list the Study title, 

Sponsor’s name and Participating Investigator 

on the Institution’s website (to encourage 

patient enrollment).

Miscellaneous Provisions 

• Governing/Controlling law 

• Amendments & Severability 

• Assignment 

• Return of drugs/devices 

• Record retention for “x” years 

• Debarment warranty 

• Alternative Dispute Resolution

Exhibits/Amendments 

• Itemized cost breakdown 

• Schedule of payments 

• Protocol –by reference 

• Investigator’s Agreement/Acknowledgement 

• LOI – Letter of Indemnification


• Cost and payment terms of the 

contract 

• Start‐up costs (non‐refundable, administrative) 

• incentives (enrollment & time targets) 

• administrative fees (institutional overhead) 

• infrastructure costs (IRB, advertising, 

pharmacy, radiology set up) 

• In the event of early termination what will be 

paid for work completed and obligated costs?


• Cost and payment terms (continued) 

• Location and Payee Information 

• Payment Schedule (Usually separate) 

• Per Subject Fee 

• Screen Failure 

• Optional payments 

• Additional fees ( Translation, SAE’s, 

Monitoring, Closeout)

Sample Payment terms 

Visits/Procedures Completed: 

• Baseline $880.10 

• Week 1 $795.60 

• Week 2 $2,214.10 

• Week 3 $711.10 

• Week 6 $2,090.50 

• Week 12 $425.10

Sample Payment Terms 

• Variable Patient Fees. 

Screen Failure Fee. ….a rate of ONE THOUSAND, SIX 

HUNDRED SEVENTY‐FIVE DOLLARS ($1,675) per patient, up to 

a maximum of two (2) screen failures for every seven (7) 

Evaluable Patients 

• CT Scan Fee. …on a pass through basis, for the actual and 

reasonable cost of any Study related CT scans performed at 

Visit 12 …Under no circumstances will CT Scan Fee 

reimbursement exceed ONE THOUSAND, TWO HUNDRED 

DOLLARS ($1,200.00). Institute shall provide …with all 

necessary documentation in support of the CT Scan Fees.

Budget Samples 

• Imbedded Budget 

• Total by procedures 

• Spreadsheet by visit 

• Appendix Payment Schedule/Budget

Imbedded 

MDP, on behalf of Sponsor, agrees to 

provide financial support for ACHD QuERI 

in the amount of one thousand and two 

hundred dollars ($1,200.00) (U.S. Dollars) 

per evaluable subject according to Exhibit 

B (hereinafter known as “Budget”), the 

terms of which are incorporated herein and 

made a part of this Agreement. Payments 

will be provided quarterly and will be based 

on the number of subject case report forms 

that have been completed for subject visits, 

as described in Budget, in a given quarter.

Sample by Visit 

Visits Completed: 

• Baseline $ 880.10 

• Week 1 $ 795.60 

• Week 2 $ 2,214.10 

• Week 3 $ 711.10 

• Week 6 $ 2,090.50 

• Week 12 $ 425.10

Spread sheet by Frequency 

Procedure Description Cost Frequency Cost/Patient 

IC 60 1 60 

Hist/Phys and pelvic1 (enrollment) 250 1 250 

Hist/Phys and pelvic (3 visits) 150 3 450 

Urine Pregnancy Test 35 1 35 

Trichomonas 70 1 70 

Chlamydia trachomatis DNA test 70 1 70 

Neisseria Gonorrhoeae DNA test 70 1 70 

Blood test at each visit to test for copper levels GoldenCare Group 31 4 124 

Vaginal yeast culture2 73.5 4 294 

Handling fee 60 4 240 

CRF completion and diary review 50 4 200 

Patient incentive – visit 1, visit 2 25 2 50 

Patient incentive – visit 3, visit 4 50 2 100 

Colposcopy Examination for GoldenCare Group 350 3 1050 

SubTotals 3063 

Totals inc. 35% institutional overhead 4135.05

Spread Sheet by Procedure 

Day 1 2‐7 180 194 

Hospital 

Phone visit 

Procedure Hospital Admission Admission stay discharge Clinic Visit 2 5 TOTAL 

Informed Consent $74 $74 

Medical HX $74 $74 

Inclusion/Exclusion $0 

Full Physical Exam $147 $147 

Vitals & Weight $0 

Medication history $30 $30 $30 $90 

Smoking history $0 

Blood Tests 

Lab Collection and 

$53 $53 $106 

Processing $5 $5 $10 

Urine Pregnancy Test $13 $13 $26 

Total $322 $0 $104 $101 $0 $527 

35% Overhead $112.82 $0.00 $36.40 $35.35 $0.00 $184.57 

TOTAL PROJECT COST $435 $0 $140 $136 $0 $712

How to calculate a clinical trial 

budget? 

• Starts with procedures of the project

Sample Schedule of Events 

Study Procedures Table Screening Visit 1 Visit 2 

Consent x 

Physical Exam x x x x 

Vitals x x x x 

Concomitant Medication x x x 

Serum Pregnancy Test x x x 

Chemistry Profile x 

Hematology Profile x x x x 

Drug Accountability x x x 

Adverse Events x x x x 

Looks like spread sheet without prices 

Early 

Study 

D/C

Standard Calculations (by OCT) 

• Coordinator Time (for per subject fee) ‐ % effort 

• 5 hrs for screening visit to cover pre‐screening unless paid 

separately 

• 1 –2 hr additional per visit for sample processing if 

required 

• Add up time for questionnaires 

• Generally 1 hr for visit plus additional time for drug 

administration/monitoring if required 

• 40 hrs. for pre‐study work/ total number of subjects 

• 5 monitoring visits @ 8 hrs ea / number of subjects per 

year

Estimation of time –Other activities to 

• Pre‐study activities 

include 

• Site Qualification Visit 

• Attend Investigator Meeting 

• IRB application preparation 

• Budget submission (if completing it) 

• Process other regulatory documents

Study activities 

• Study initiation visit 

• Recruit subjects 

• Conduct staff in services 

• Screen subjects 

• Consent subjects/guardian 

• Schedule subjects 

• Administer trial medications

• PI time 

Standard Calculations 

• 1 hr for IRB submission/review 

• 1 hr for IC 

• 1 hr first physical 

• ½hr each additional physical 

• ¼hr for just signing off CRF per visit 

• Additional time as needed for procedures

Standard requests when starting Industry 

Negotiations 

• Non‐refundable administrative start up fee 

• Standard ‐ $5,000 

• Registry study ‐ $2,500 

• Pharmacy set up fee $2,000 (includes both start up ($1,500 

and $500 close out) 

• $250‐$500 Radiology or Laboratory start up fee if numerous 

procedures or considerable set up work 

• $100 per SAE at our institution and $50 per IND safety report 

• $2,500 record storage fee 

• $60 per hour for monitor visits with coordinator or $250 per 

visit

IRB fees – Industry Funded only 

• External IRB (WIRB) paid directly including translations; 

$2000 for translations estimated 

• Local IRB fees 

– $2,800 for the initial review 

– $1,200 Each annual review 

– $490 each change/amendment/external request 

• Administrative IRB review fees when sponsor pays WIRB 

directly 

– Initial Review ‐ $500 

– Annual Review ‐ $200 

– Each amendment or change $100

Internal Budget ‐ Industry 

• Time of Coordinator, PI 

• Procedure Costs 

• Patient Stipend 

• Supplies 

• Miscellaneous/Residual (Final Budget only) 

• OCT fee ‐ 10% of Direct or 8.3% of total 

• Direct total 

• University Overhead –20% of Direct Total –or 16.7% of total 

• Total – [Per Subject plus allocated start up fee] * [# subjects]

Internal Budget of Costs 

Item Notes/# CPT Hosp. TUP Per subject 50 Subjects 

Coordinator - hrs 15 50 $750.00 $37,500.00 

PI - hrs 2 100 $200.00 $10,000.00 

Chest X ray 2 71030 $53.63 $16.67 $140.60 $7,030.00 

Supplies $5.00 $250.00 

Record Storage $10.00 $500.00 

Patient Stipend $10.00 $500.00 

Subtotal $1,115.60 $55,780.00 

Miscellaneous $384.40 $19,220.00 

OCT 10% $166.67 $8,333.33 

Direct $1,666.67 $83,333.33 

F&A 20% $333.33 $16,666.67 

Total $2,000.00 $100,000.00

Clinical Procedures: Research only 

• Industry Funded Trials 

• 150% of Medicare rate; $50 separate surcharge 

for MRI’s, Scans, to cover additional work and 

measurements 

• Grants/ Federal, Unfunded Department 

Research 

• [Hospital current charge master] * [agreed upon 

percentage in federal negotiated rate sheet] 

• On‐Line (Research Accounting Services)

Internal Budget of Costs 



PI - hrs 2 100 $200.00 $10,000.00 

Chest X ray 2 71030 $53.63 $16.67 $140.60 $7,030.00 

Supplies $5.00 $250.00 



Subtotal $1,115.60 $55,780.00 


OCT 10% $166.67 $8,333.33 

Direct $1,666.67 $83,333.33 

F&A 20% $333.33 $16,666.67 

Total $2,000.00 $100,000.00

Final Internal Budget 



PI - hrs 2 100 $200.00 $10,000.00 

Chest X ray 2 71030 $53.63 $16.67 $140.60 $7,030.00 

Supplies $5.00 $250.00 



Subtotal $1,115.60 $55,780.00 


OCT 10% $166.67 $8,333.33 

Direct $1,666.67 $83,333.33 

F&A 20% $333.33 $16,666.67 

Total $2,000.00 $100,000.00

Additional study activities 

• Maintain drug accountability documentation 

• Vital signs 

• Obtain/Process lab specimens 

• Interview (AE assessment, diaries, questionnaires) 

• CRF Forms 

• Preparing source document forms 

• Enter data into electronic data system

Additional study activities 

• Resolve data queries 

• Coordinate/Attend monitoring visits 

• Monitor/Code/Interpret SAE forms 

• IRB correspondence 

• Protocol amendments 

• Sponsor correspondence 

• Update regulatory documents 

• Monitor payments from sponsor 

• Coordinate/attend study termination visit

Hidden activities: 

• Clarification of protocol 

• Telephone patient screening 

• Communicating with referral sources 

• Preparing and faxing enrollment 

• Receiving and managing clinical supplies 

• Processing stipend checks 

• Rescheduling subject visits

Coordinator/PI Role 

• Identify for OCT if time estimates seem 

incorrect

Pharmacy Charges 

Included in Internal and Negotiated Budget 

• Randomization 

• Administration 

• Drug 

• Inventory 

• Close out if not in start up

eSPAF –for Industry Trials 

• Requested when project received so not waiting 

when hard copies received; we will change budget 

• Need to process agreement for signature 

• Direct, Indirect and Total budgets usually highlighted 

in yellow on Internal budget 

• Attach Internal Budget sent to you if done after 

completion of negotiations 

• For Industry trials –don’t need all PI’s on eSPAF to 

process for signature. Need PI, Administrator and 

Chair 

• Always clinical trials contract; 20% overhead –F&A 

• Unless $0 budget

Grant Projects 

• Same Considerations but need to know the 

difference between: 

• Direct costs 

• Modified Direct Costs 

• Indirect costs 

• Total Costs 

• Indirect rate: FY 2013 – 54% 

FY 2014 – 55%

Determinantion of Staffing and 

Percent Efforts 

• First year or start‐up time 

• F/U years or study implementation years 

• Last year or close out period

Other categories of expense 

• Office Supplies 

• Equipment 

• Postage 

• Photocopy/Printing 

• Patient Care Costs –Clinical procedures 

• Study Start‐up and close out fees 

• Monitoring in IND or IDE studies

Other considerations cont.: 

• Professional Meetings and Travel 

• Patient Incentives and Reimbursements 

• Software 

• Computing Costs 

• Consultants

Study Timeline Example 

Task 

Finalize Study 

Protocol/Irb 

Approval x 

Hire and Train 

Personnel x 

Develop CRF's and 

Study Manuals x 

Year 1 Year 2 Year 3 

Develop Study 

Database 

Recruitment and 

x 

Randomization 

Intervention 

x x 

Implementation 

Data Collection at 

x x 

Study Visits x x 

Data cleaning x x x 

DSMB 

Meetings/Reports 

Final analysis and 

x x x 

Manuscripts x

Grant Year (Y1, Y2, etc) Y1 Y2 Y3 Y4 Y5 

Account Description 

Fringe 

Rate 

Account 

Expense 

Code 

Full Time Faculty Salaries 33.1% 6001 $ 106,761 $ 109,964 $ 113,263 $ 116,661 $ 120,161 

AY Faculty Salaries (Main Campus Faculty) 33.1% 6001 $ ‐ 

Full Time Technical Professional 33.1% 6520 $ 45,788 $ 47,161 $ 48,576 $ 50,033 $ 51,534 

Part Time Faculty Salary 8.4% 6201 $ ‐ 

Clinical Faculty 19.6% 60xx $ ‐ 

Part Time Technical Professional 8.4% 6620 $ ‐ 

Full Time Administrative Salaries 33.1% 6500 $ ‐ 

Full Time Clerical Salaries 33.1% 6550 $ ‐ 

Part Time Clerical Salaries 8.4% 6650 $ ‐ 

Post Doc 27.3% 6580 $ 41,076 $ 42,309 $ 43,578 $ 44,885 $ 46,232 

Visiting Scholar 6660 $ ‐ 

FT Temporary Salaries 0.0% 6672 $ ‐ 

TA/GA Salaries 23.0% 63xx $ ‐ 

Student Workers/Workstudy 0.0% 67xx $ ‐ 

Fringe Benefits 6990 $ 61,707 $ 63,559 $ 65,465 $ 67,429 $ 69,452 

Consultants 7305

Office Supplies 7208 

Publications 7375 

General Supplies (Lab) 7200 

Chemicals for Lab Tests 7251 

Computer Software 7201 

Computer Equipment < $5,000 7218 

Telephone Services 7421 

Travel ‐ Domestic 7500 

Travel ‐ Foreign 7505 

Food 7602 

Participant Support 7357 

Data Communications 7424 

Equipment Expendable < $5000 7214 

Animal Purchase 7264 

Animal Care & Use 7151 

Drugs 7255 

Shared Resources 7159 

Subcontracts ≤ $25,000 7386 

Miscellaneous 7600 

Sub‐Total 

F&A Costs (Indirect): Adjust formula according to rate(s) effective during period of award 7623 

Equipment‐Fixed >$5,000 7880 

Equipment‐Movable > $5,000 7870 

Subcontracts > $25,000 7387 

Patient Care Costs 7150 

Tuition 7611 

Total

Budgeting for a Clinical Trial 

• Develop budget based on actual costs 

• Develop budget for recovery of all costs and 

at a reasonable margin 

• Consider Delayed Cash Flow in Industry Trials 

–i.e. 10% holdback till the end of the trial.

Questions

Developing a Study Budget and Contract - Temple University

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