Start Up Fees, Invoice, and Financial Expectations

Start Up Fees, Invoice, and Financial Expectations

Fixed Study Start Ups: Non-negotiable and due within 30 days of executed contract

Fee Description:

Amount:

Covers:

Regulatory Preparation and Compliance

$13,500.00 Preparation and submission to WIRB or local IRB (HawkIRB), internal review boards such as

Fees

Protocol Review and Monitoring Committee (PRMC), Radiation Committee, and Clinical

Research Unit (CRU); UI Joint Office for Compliance applications and creation of Research

Billing Plan; Informed consent form review and preparation.

Administration Fee

Protocol review; Site selection visit; Site Initiation visit, PRMC scientific review; Safety committee review; Budget preparation and negotiation; IT programming and set-up.

Investigator Fee

Principal Investigator (PI) protocol and feasibility review; PI legal documentation including CDA; Meetings with budget and regulatory staff; Investigator meeting.

Study Coordinator Fee

Research coordinator efforts including protocol review, meeting with budget, regulatory, and ancillary departments; Site initiation visit; Investigator meeting; Source

documentation development; Electronic data capture training.

Facilities & Administrative (F&A) Fees Total

$3,510.00 26% for all Industry-sponsored clinical trial activity. $17,010.00

Study Start Ups: Non-negotiable and due within 30 days of executed contract (F&A Fees additional)

Fee Description:

Amount:

Covers:

UI Human Subjects Office (HSO) Fee

$1,500.00

HSO preparation and review prior to WIRB submission; Review of local informed consent form. F&A will be assessed at rate of 26%

Hawk IRB Fee (WIRB fees below) Hawk IRB Expedited Review Fee

$2,500.00 $1000

IRB fee for studies sponsored by cooperative groups, consortiums, investigator- initiated, and select industry trials. Also charged to any observational studies or those involving the UI Institutional Biosafety Committee. This fee replaces any WIRB fees. No F/A assessed on this fee which includes initial review, continuing reviews, all protocol amendments and modifications and submission of SAEs.

IRB fee for studies that require expedited review only.

Investigational Pharmacy Set Up Fee--1st

year only

$1,300.00

CRU Review Fee

$573.00

Through UI Investigational Pharmacy Services: Protocol and Investigator's Brochure review; Drug receipt and inventory; Dispensing procedures and staff training; Site initiation meeting; Return and close-out. F&A fees are additional. Only charged if study design requires use of CRU. Covers CRU nursing and administration to review protocol, complete lab tech consultation, and costs of ancillary staff and medical director review. F&A fees are additional.

CRU Order Building Training Document Translation Fee

$110.00/hr Time required to build orders and clinical notes required for CRU appointments

$110.00/hr $40.00/hr.

Includes SIV/EDC/GCP/equipment, procedures and any other training required by the sponsor. Billed per person.

Time required to translate informed consent documents and forms for non-English speaking study participants

Annual and Recurring Fees (F&A Fees additional and Invoiced to Sponsor)

Fee Description:

Amount:

Covers:

Departmental Surcharge

15%

Each department assesses 15% of the total direct cost received (or 12 % of the total

received) from each trial to reflect the responsibility the faculty PI has for administrative

oversight of the trial. This amount reflects the effort each faculty investigator

contributes to the project. This fee is not intended to compensate the faculty member

for any physician fees due to actual clinical work accomplished for each study

participant.

Annual Regulatory and Financial Maintenance Fee--After 1st Year

$2,000.00

Annual Study Coordinator Maintenance ? After 1st Year (Protocol Specific)

Fee

$1,000

-

$5,000

Continuing regulatory and administrative maintenance. Covers IRB continuing reviews,

modifications, safety reports, filing, binder upkeep, IT maintenance, paperwork,

regulatory documentation (1572, CVs, Financial Disclosures); Monthly financials,

invoicing, and reconciliations between sponsor and site.

Binder Fee and Source Documents (Time required printing documents from electronic portal for regulatory binder. This includes money needed to pay for supplies: paper, printer, ink, binder.)

Conference Calls Pre-Screening Subject Fee Re-consent Fee Weekly/Monthly Enrollment Logs Sponsor Specialized Training

Annual Investigative Pharmacy Maintenance Fee--After 1st Year

$700.00

Annual Review Hawk IRB Expedited Review $500.00

Fee

Inventory control/accountability; ordering and drug stock; date extensions; monitoring visits; internal drug audits; expired drug reviews and closeout/return. Annual continuing review for expedited protocol.

Hawk IRB Fee

500.00

Continuing review of the protocol.

UI Human Subjects Office (HSO) Fee

$750

Continuing review of the protocol submitted to WIRB. F&A will be assessed at rate of 26%

IRB Fees (Western IRB) Protocol Amendment Fee Binder fee

Direct

$2000.00 $400

Sponsor invoiced directly for WIRB Fees. If sponsor requires UI to pay WIRB fees, sponsor invoice will be assessed 26% F&A and 15% Departmental overhead fee. Fee schedule available at or we can email you the current pricing.

Amendments including contract or budgetary changes. Time required to print documents from electronic portal for regulatory binder. This includes money needed to pay for supplies: paper, printer, ink, binder.

Monitoring Visits, Per Day ? without electronic medical record review

$400.00/day

$500.00/ Monitoring Visits, Per Day ? with electronic 4 hours medical record review

Scheduling and coordination with PI, study coordinator, regulatory, pharmacy and other

visits for monitor; organize documents/binders; time with monitor; facility orientation, IT

and online medical documentation access. In-Person or by phone monitoring if required. Scheduling and coordination with PI, study coordinator, regulatory, pharmacy and other visits for monitor; organize documents/binders; time with monitor; facility orientation, IT and online medical documentation access. In-Person or by phone monitoring if required. Includes monitor time to orient to EMR and sit with monitor if necessary.

$1000.00/ Monitoring Visits, Per Day ? with electronic 8 hour day medical record review

Scheduling and coordination with PI, study coordinator, regulatory, pharmacy and other visits for monitor; organize documents/binders; time with monitor; facility orientation, IT and online medical documentation access. In-Person or by phone monitoring if required. Includes monitor time to orient to EMR and sit with monitor if necessary.

Conference calls

$110/hr

Per person charge for required conference calls.

Source documents

Pre-screening subject fee Monitor Change Fee per change SAE initial and follow-up reporting

$25/subject $600/mo.

$300.00 $800.00

Time required for printing documents from electronic portal and assembling into subject study folder. This includes money needed to pay for supplies: paper, printer, ink, and folder.

Assessed from beginning date of open enrollment to close of study enrollment for daily review of inpatient and clinic census for potential study subjects.

Time for coordinator, regulatory staff, PI and pharmacists to re-introduce new monitor to building, pharmacy, regulatory procedures, and eCRF's Coordinator time to report initial SAEs and follow-up/discharge reports.

Unscheduled Visits, Each Re-consent fee Study Closeout Screen Failures ? per subject

Sponsor-specific specialized training

Weekly/Monthly Enrollment Logs Safety Reports--After 1st 50 Reports

Long Term storage fee

Audit fee Supply costs

Translator/Interpreter services

$350.00 $100.00 $1,000.00 $400.00

$110/hr/ person $50.00 $300.00

Basic coordinator time to follow unscheduled subject visit required by protocol. Re-consenting subject required due to protocol amendment. Regulatory and financial closeout; long-term storage/archiving; shredding. Based on budgeted screening visit costs or pro rated based on tasks performed. Additional time for coordinator, staff, or PI for required online courses or other training.

To send each enrollment log if required by sponsor. Per 50 completed IND Safety Reports up to 50 additional reports. First 50 have no invoiced charges. Each additional set of 50 reports will be charged $300.00/set.

$500/yr

Storage of all study related documents. To be paid with close-out costs based on length of required storage.

$1000.00/day Time required for gathering documents and attending to auditor.

$250/yr

Any miscellaneous supplies required for the study that are not supplied by the sponsor, e.g.

gloves, hand sanitizer, etc.

$40.00/hr Fee assessed for translator to attend visit and translate forms. Assessed per patient per hour.

Expectations-Things to Know: Departmental Fee The University of Iowa Clinical Departments charge a fee on all monies for industry sponsored clinical trials (15% on direct revenue). In the start up fees it is called Departmental Fee . This fee is included in the negotiated per patient amount as a line item. For invoiceable items it is added to the invoice total (along with 26% F&A/overhead). This rate is non-negotiable and will be assessed on all invoices including pass-thru/invoice/direct expenses.

Institutional Overhead The University of Iowa charges overhead (also known as F&A or Facilities and Administration fees) on all expenses. The University of Iowa's Federally Negotiated F&A rate is currently 51%, and raises to 52.5% on July 1, 2016. The University has agreed to lower the overheard rate for industry sponsored clinical trials to 26%. This rate is non- negotiable and will be assessed on all expenses (including pass-thru/invoice/direct expenses/departmental fees). fa-costs

Fees are reviewed annually on July 1st and subject to change.

***Any invoice we send will have overhead and departmental fees added to them as we are assessed these fees by the University and the

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