1. PRCSG Training Webinar: Budget for Industry Sponsored Studies
Anne Johnson, Senior Specialist-Project Management
Cincinnati Children’s Hospital
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2. Outline Start up costs overview
Comparative start up costs – 3 clinical trials
Routine study visit costs
Conclusion

3. Start up costs (1) IRB fees
Average initial submission for a local IRB $3500
Average fee per amendment approval $1250
Average fee for continuing review $2000
The initial submission fee and the time/labor costs needed for the submission packet to be completed are usually included in the start up costs provided before the study starts.
The amendment and annual review fees usually have to be invoiced separately as they occur.

4. Start up costs (2) Pharmacy fees
Average start up fees for investigation pharmacy are $3,500.
Every visit usually incurs an additional dispensing fee.
Check with your pharmacy about fees for drug reconciliation and policies for return of used and unused drug at every study visit.
Pharmacy staff should take care of their own delegation log and study forms for drug receipt, dispensing, reconciliation, and destruction.

5. Start up costs (3)
Administrative start up fee can range from 5-10K depending on the sponsor.
Regulatory coordinator time to collect and file necessary “reg docs” (1572, delegation log, CVs, licenses, HSP training, financial forms)
Time needed to write consents per site and sponsor templates, IRB submission documents
Training followup for protocol, IB, pharmacy manual for all staff listed on the delegation log

6. Start up costs (4)
Will you use a clinical trial research center? Costs and time for application.
Sometimes the CTRC requires a protocol application in addition to the IRB submission.
The hourly costs for CTRC use can either be under your “other costs” section of the contract (need to be invoiced) or included in the patient per visit costs.

7. “Other costs”
Some contracts will offer close out fees as well as start up fees.
Check your contract for other costs that must be invoiced to collect payment.
Screen failures
pK sampling if not included in the patient visit costs

8. Comparative start up costs by sponsor
Local IRB fees
$3,500
actual
$4,000
IRB amendment fee
$1,250
IRB annual review
$2,000
Admin start up
$10,385
$12,750
$6,500
IRB document prep
none
$1,200
Pharmacy start up
$2,500
Lab set up
$550
Screen fails
$921
$1,619
Close out fee
Additional samples
$40
$300
$95
Record retention
$1,360
Total start up costs
$20,596
$20,660
$12,214

9. Routine study visit costs
Schedule of events should be broken down by visit in the contract to show what needs to be done when and how much the sponsor will pay for the activity.
These costs are usually paid directly once the visits are completed and entered into the EDC. No invoice is needed to collect these payments.
It is a good idea to double check these activities with your clinic practice procedures. Most hospitals require a breakdown of research vs. standard of care charges for study visits.

10. Routine study visit typical costs (1)
Informed consent/parent permission/assent and complete medical history $150-$200
Uveitis assessment (slit lamp exam) $100
Complete physical exam (baseline and pivotal time points) $300-$400
Partial physical exam (other time points) $250
Tanner stage (usually done twice-baseline and last visit) $75-$100
Quantiferon-TB (blood test) done at baseline or screening visit and possibly yearly $75-$100

11. Routine study visit typical costs (2)
Complete joint evaluation by certified assessor (sometimes blinded depending on protocol) $75-$125
Physician Global Evaluation of Overall Disease Activity $50-$75
Subject Reported Outcomes
CHAQ
CHQ
PedsQL
Pain and global evaluations $35-$50

12. Routine study visit typical costs (3)
ESR or CRP (marker of inflammation)- this could be onsite testing or collection and shipping to central lab, prices vary by process $25-$50
Sample collection, processing, and shipping for central lab $50-$80
Study Treatment management
Review patient diary, answer questions
Collect used/unused IP, reconciliation records
Pharmacy orders and returning used/unused IP
Dispense new IP to patient $85-$100

13. Routine study visit typical costs (4)
Study Treatment management (continued)
If IP is by injection, some protocols require that the subject administer while in clinic and then wait 30 minutes for repeat vitals
If IP is by infusion, this extra cost for CTRC or infusion center might be included in the visit charge or might be listed under “other costs”. Make sure the cost of the infusion is listed somewhere in the contract. Typical infusions take minutes and then need repeat vitals.

14. Routine study visit typical costs (5)
Study Coordinator Fees
Confirming eligibility criteria with PI
Consenting procedures
Prior/concomitant meds
Vital signs, height, weight, possible repeat vitals after IP administration will be needed
Randomization
Submitting assessments to PRCSG for some studies and some visits
AE/SAE review, monitoring with PI $150-$200

15. Routine study visit typical costs (6)
Data entry into EDC $100-$150
Subject/caregiver travel reimbursement (depends on protocol and time spent on site) $50-$100
PK sampling might be part of protocol $40-$50
Urine or blood pregnancy tests for WOCBP, depending on protocol, every time new IP is given or as requested by sponsor $50

16. Routine study visit typical costs (7)
Total costs should be listed per visit and then per patient
Costs should be listed with and without overhead

17. Conclusion
Repeat webex September 13, 11am
Questions?
Comments?
Proposed topics for future webex training?